Document text
Page 1 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965944
Page 2 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/14/2020
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965945
Page 3 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10871557]
2.Birth Date: 1986
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):ASIAN
6.Racial Designation:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0965946
Page 4 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965947
Page 5 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965948
Page 6 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965949
Page 7 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to under cooked shrimp]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin D Deficiency]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POLYCYSTIC OVARIAN SYNDROME]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965950
Page 8 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965951
Page 9 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
2.Weight: [55.92]
3.Unit: kg
4.Height: [154.94]
5.Unit: cm
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965952
Page 10 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965953
Page 11 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/14/2020
2.Randomization Number: [107612]
3.Randomization Group: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965954
Page 12 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BSJ8JZ]
5.bSample ID [BSJ21L]
5.cSample ID [BR2DSG]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965955
Page 13 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BR2DRB]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965956
Page 14 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/14/2020 13:08
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
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965957
Page 15 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965958
Page 16 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965959
Page 17 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965960
Page 18 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/5/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965961
Page 19 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BR8Y7F]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965962
Page 20 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was
ObservedNot Done Comments
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965963
Page 21 of 158
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965964
Page 22 of 158
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965965
Page 23 of 158
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965966
Page 24 of 158
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965967
Page 25 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965968
Page 26 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965969
Page 27 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965970
Page 28 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965971
Page 29 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965972
Page 30 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965973
Page 31 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965974
Page 32 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965975
Page 33 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965976
Page 34 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965977
Page 35 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965978
Page 36 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965979
Page 37 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965980
Page 38 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965981
Page 39 of 158
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 EXPOSURE DURIN
G PREGNANCY Oct/24/2020
UNK:UNK YES Repeating
Pages
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965982
Page 40 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965983
Page 41 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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:
[Sexual Intercourse]
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965984
Page 42 of 158
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965985
Page 43 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965986
Page 44 of 158
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965987
Page 45 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965988
Page 46 of 158
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965989
Page 47 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965990
Page 48 of 158
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatme
ntStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965991
Page 49 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965992
Page 50 of 158
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965993
Page 51 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965994
Page 52 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965995
Page 53 of 158
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965996
Page 54 of 158
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965997
Page 55 of 158
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965998
Page 56 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0965999
Page 57 of 158
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966000
Page 58 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966001
Page 59 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966002
Page 60 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966003
Page 61 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966004
Page 62 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966005
Page 63 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966006
Page 64 of 158
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966007
Page 65 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966008
Page 66 of 158
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to return
for Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR otherwise
not eligible
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966009
Page 67 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966010
Page 68 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966011
Page 69 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966012
Page 70 of 158
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966013
Page 71 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/5/2020
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966014
Page 72 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966015
Page 73 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin
Cannon Approved Mar-05-2021 15:33:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966016
Page 74 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-19-2020 10:43:32 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966017
Page 75 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966018
Page 76 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
1Nov-06-2020 09:10:47 (UTC-05:00)
Eastern Time (US & Canada)IP PERMANENTLY WITHDRAWN
DUE TO PREGNANCY
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966019
Page 77 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966020
Page 78 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966021
Page 79 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966022
Page 80 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966023
Page 81 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966024
Page 82 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966025
Page 83 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966026
Page 84 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966027
Page 85 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
10Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966028
Page 86 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
11Nov-11-2020 09:50:35 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966029
Page 87 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Nov-09-2020 15:40:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966030
Page 88 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin
Cannon Approved Mar-05-2021 15:33:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966031
Page 89 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020
10:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020
10:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966032
Page 90 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020
10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Ob
tained
Oct/14/2020Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966033
Page 91 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020
10:41:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10871557Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020
10:41:51
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1986Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020
10:43:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-09-2020
17:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966034
Page 92 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-09-2020
16:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Nov-09-2020
16:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPANI
SH ORIGINTranscription
Error
Nov-09-2020
08:52:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL -
Ethnicity is
reported as NOT
Hispanic;
however, SAE
report has
ethnicity
reported as
Hispanic. Please
review,
harmonize
ethnicity status
and update in
the required
location.
Nov-09-2020
07:43:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Candidate CLINICAL -
Ethnicity is
reported as NOT
Hispanic;
however, SAE
report has
ethnicity
reported as
Hispanic. Please
review,
harmonize
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966035
Page 93 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
ethnicity status
and update in
the required
location.
Nov-09-2020
07:42:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed reissue as
Candidate
Nov-06-2020
14:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered please unfreeze
so that I may
update
Nov-06-2020
09:34:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL -
Ethnicity is
reported as NOT
Hispanic;
however, SAE
report has
ethnicity
reported as
Hispanic. Please
review,
harmonize
ethnicity status
and update in
the required
location.
Oct-19-2020
10:43:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966036
Page 94 of 158
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020
10:43:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASIANInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966037
Page 95 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
10:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966038
Page 96 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020
10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966039
Page 97 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020
10:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Allergy to un
der cooked sh
rimp
Start Date
:UNK/UNK/2
005
Ongoing: YESInitial Entry
Oct-19-2020
10:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Allergy to un
der cooked sh
rimp
Start Date
:UNK/UNK/2
005
Ongoing:Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020
10:48:46
(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:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966040
Page 98 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-19-2020
10:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to under cooked s
hrimpInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-19-2020
10:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020
10:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-19-2020
10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Vitamin D
Deficiency
Start Date: UNK/UNK
/2018
Ongoing: YESInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966041
Page 99 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020
10:50:07
(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
Nov-10-2020
23:42:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Nov-10-2020
17:03:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered MED HX HAS
BEEN
UPDATED
Nov-09-2020
08:50:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL - per
PREGNANCY
report, subject
has a history of
polycystic ovary
disease. Please
review for
clinical relevance
to the pregnancy
event, and add to
Medical History
if appropriate
Nov-09-2020 ACV0PFEINFP6000 Query 2: Candidate CLINICAL - per
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966042
Page 100 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
07:41:08
(UTC-05:00)
Eastern Time (US
& Canada)PREGNANCY
report, subject
has a history of
polycystic ovary
disease. Please
review for
clinical relevance
to the pregnancy
event, and add to
Medical History
if appropriate
Nov-09-2020
07:40:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed move to
candidate form
Nov-06-2020
14:58:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered please unfreeze
so that we may
update
Nov-06-2020
09:27:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL - per
PREGNANCY
report, subject
has a history of
polycystic ovary
disease. Please
review for
clinical relevance
to the pregnancy
event, and add to
Medical History
if appropriate
Oct-19-2020
10:50:07ACV0PFEINFP6000 Data Entry:
Vitamin D DeficiencyInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0966043
Page 101 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)
1.b Start Date:
Date Location User Value Reason
Oct-19-2020
10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020
10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-10-2020
17:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History
Term:POLYCYSTIC
OVARIAN SY
NDROME
Start Dat
e:UNK/UNK/20
05
Ongoing
:YESInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966044
Page 102 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Line/MH Number:
Date Location User Value Reason
Nov-10-2020
17:03:29
(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
Nov-10-2020
17:03:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
POLYCYSTIC OVARI
AN SYNDROMEInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-10-2020
17:03:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-10-2020
17:03:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966045
Page 103 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-19-2020
10:44:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966046
Page 104 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
55.92Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
154.94Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966047
Page 105 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Unit:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.3Initial Entry
7.a
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 36.6
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966048
Page 106 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
7.a Temperature:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-19-2020
10:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966049
Page 107 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966050
Page 108 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Specimen Type:
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Iden
tifier:113
Test:: Choriogonad
otropin Beta_
PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020
10:45:18ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966051
Page 109 of 158
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00) Eastern
Time (US & Canada)PX113
6.a Result:
Date Location User Value Reason
Oct-19-2020
10:45:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966052
Page 110 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020
10:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020
10:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
107612Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966053
Page 111 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
10:46:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
10:46:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
17:59:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
10:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966054
Page 112 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-19-2020
10:46:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
17:59:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJ8JZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
17:59:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSJ8JZInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020
18:01:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSJ21
LInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966055
Page 113 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
18:01:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSJ21LInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
18:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR2DS
GInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
18:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR2DSGInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966056
Page 114 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
10:46:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
10:46:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
17:58:35
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
10:46:38
(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.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966057
Page 115 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-19-2020
10:46:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
17:58:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR2DR
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
17:58:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR2DRBInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966058
Page 116 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 13:08Initial Entry
5. Anatomical Location:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966059
Page 117 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION PE
RIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Oct-19-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966060
Page 118 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10:47:13
(UTC-05:00) Eastern
Time (US & Canada)YES
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966061
Page 119 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-19-2020
10:47:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966062
Page 120 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020
08:52:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966063
Page 121 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Nov-06-2020
09:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
2.a
Date Location User Value Reason
Nov-06-2020
09:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperatur
e:36.7
Temperatur
e Unit:C
Temperatur
e Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-06-2020
09:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966064
Page 122 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-06-2020
09:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-06-2020
09:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-06-2020
09:07:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0966065
Page 123 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966066
Page 124 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Specimen Type:
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Iden
tifier:113
Test:: Choriogonad
otropin Beta
_PX113
Result:: POSITIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-06-2020
09:07:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-06-2020
09:07:57ACV0PFEINFP6000 Data Entry:
Choriogonadotropin BetInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966067
Page 125 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-05:00)
Eastern Time (US
& Canada)a_PX113
6.a Result:
Date Location User Value Reason
Nov-07-2020
03:02:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-06-2020
09:12:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered PREGNANCY
DISCOVERED
AT VISIT 2.
SUBJECT HAD
NEGATIVE
PREGNANCY
TEST AT V1
AND NO
REASON TO
BELIEVE SHE
WAS
PREGNANT.
VAX 2 NOT
GIVEN AT V2
Nov-06-2020
09:07:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Lab result is
“Positive”, but
subject has been
vaccinated.
Please review
and update as
appropriate. Else
explain.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966068
Page 126 of 158
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-06-2020
09:07:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966069
Page 127 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020
09:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020
09:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
09:32:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-06-2020
09:08:12
(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.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966070
Page 128 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-06-2020
09:08:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020
09:32:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BR8Y7
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020
09:32:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR8Y7FInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966071
Page 129 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-12-2020
02:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-11-2020
09:51:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Not Done added
to form level
comment
Nov-11-2020
09:50:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Nov-11-2020
04:07:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Patient is
discontinued, if
correct please
update this form
as Not done by
selecting form
level comment
or else clarify.
Thank you.
2. Treatment Name
Date Location User Value Reason
Nov-11-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0966072
Page 130 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)Not Done
3. Formulation:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0966073
Page 131 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966074
Page 132 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-11-2020
09:50:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966075
Page 133 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966076
Page 134 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020
09:14:19
(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
Nov-16-2020
11:09:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Clos
edfollow-up was received and
already updated in safety
database
Nov-16-2020
11:08:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Reis
sued:OpenedSAE RECON 1:Per PSSR
confirmation, no follow up
form was received
indicating update in
term.Please submit a follow
up AEM form to update
term in Safety database.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966077
Page 135 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-14-2020
10:23:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Reis
sued:Candidat
ePending SDB update
Nov-13-2020
16:37:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ans
weredupdated report just sent to
safety with term "exposure
during pregnancy"
Nov-13-2020
05:33:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ope
nedSAE
RECON:AER#2020433197,
the term in Safety database
was recorded as pregnancy.
Per 3 Nov EDP guidance
(study communication),the
term should be reported as
'EXPOSURE DURING
PREGNANCY'. Please
submit a follow up AEM
form to update SDB term.
Nov-10-2020
08:16:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Clos
edupdate submitted (as drug
exposed pregnancy)
Nov-08-2020
09:46:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ope
nedCLINICAL - please submit
updated event term
'Exposure during
Pregnancy' as a SAE safety
update.
Nov-08-2020
09:18:52
(UTC-05:00)ACV0PFEINFP6000 Query 2: Clos
edResponse satisfies query
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966078
Page 136 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US & Canada)
Nov-08-2020
09:18:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clos
edResponse satisfies query
Nov-07-2020
12:03:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ope
nedSAE
RECON:AER#2020433197,
the term in Safety database
was recorded as pregnancy.
Based on the latest EDP
guidance,the term should be
reported as 'EXPOSURE
DURING PREGNANCY'.
Please submit a follow up
AEM form to update SDB
term.
Nov-06-2020
14:55:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ans
weredEvent is termed exposure
during pregnancy
Nov-06-2020
09:32:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ope
nedCLINICAL - Healthy
Pregnancy is not an AE,
required to be on the CRF.
Please update event to
Exposure during Pregnancy.
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EXPOSURE
DURING PR
EGNANCYInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0966079
Page 137 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020
05:17:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
Closedonset date updated in SDB. issue
resolved
Nov-17-2020
00:46:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
Reissued:
CandidatePending SDB update
Nov-16-2020
15:53:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
AnsweredAn SAE Follow up report was
sent to safety on Friday
13NOV2020 with an undated
start date of 24OCT2020
Nov-14-2020
11:41:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
OpenedSAE
RECON:AER#2020433197,onset
date reported as 24Oct2020 in
AE CRF while recorded as
14Oct2020 in Safety
database.Per LMP, subject was
pregnant before Vax1. The
correct onset date is the date of
vaccination1 = 14Oct2020.
Please confirm and update.
Nov-12-2020
13:32:54
(UTC-05:00)ACV0PFEINFP6000 Query 3:
ClosedQuery closed; will follow for
SAE update with onset date
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0966080
Page 138 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US &
Canada)
Nov-12-2020
13:00:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
AnsweredOctober 24th is the correct date.
Updated SAE reported being sent
to safety confirming this
information.
Nov-12-2020
13:00:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
Oct/24/20
20 UNK:
UNKOctober 24th is the correct date.
Updated SAE reported being sent
to safety confirming this
information.
Nov-11-2020
16:42:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
OpenedCLINICAL - Event start date is
24Oct20; however, SAE event
start date is 14Oct20. Please
review to harmonize, and update
in the appropriate location.
Nov-10-2020
08:18:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Closedwrong pt
Nov-10-2020
08:17:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedCLINICAL Estimated date of
Conception was 24Sep20 rather
than 24Oct20; please review and
update if appropriate
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966081
Page 139 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-08-2020
09:20:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies query
Nov-06-2020
14:54:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answeredupdated
Nov-06-2020
14:54:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
Oct/24/20
20 12:28updated
Nov-06-2020
09:38:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
OpenedCLINICAL Pregnancy onset
occurred before the date of +
pregnancy test at Visit 2; please
update AE & PG report
(#2020433197) to either the
estimated date of conception
(24Oct20) or date by any
ultrasound (considered more
accurate)
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
Nov/5/202
0 12:28Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966082
Page 140 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020
17:03:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response
satisfies query
Nov-09-2020
15:40:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-09-2020
15:39:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-09-2020
15:39:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Nov-09-2020 ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966083
Page 141 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
11:08:59
(UTC-05:00)
Eastern Time (US
& Canada)For exposure
during
pregnancy
events, toxicity
grade can be
entered as Not
Applicable.
Please update
Nov-06-2020
09:14:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial 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
12:28:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: C
losedResponse satisfies query
Nov-12-2020
12:44:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: A
nsweredupdated per query.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966084
Page 142 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-12-2020
12:44:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: D
eletedupdated per query.
Nov-12-2020
12:44:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
NOupdated per query.
Nov-11-2020
16:39:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: O
penedCLINICAL - The event reported
here is study Drug Exposure
during the regular pregnancy
itself, which is NOT considered
to be a SAE. Should a
complication of pregnancy
occur in the future, that event
will also be reported, with it's
own severity.
Nov-11-2020
02:45:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: R
eissued:Ca
ndidateFor Clinical review
Nov-10-2020
17:02:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: A
nsweredsubject is currently pregnant so
it is unknown if outcome will be
abnormal. What is the
appropriate choice here?
Nov-07-2020
12:01:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: O
penedSAE RECON:
AER#2020433197,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966085
Page 143 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
criteria is met there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Nov-07-2020
12:00:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: D
eletedQuery can be addressed
internally
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: C
andidateFor AE EXPOSURE DURING
PREGNANCY: Response to "Is
the adverse event serious?" is
'Yes' but "Serious Adverse
Event Number" is blank.
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
YES
Is this ser
ious even
t associat
ed with c
ongenital
anomaly
or birth d
efect?
NO
Did this s
erious ev
ent result
in death?
NOInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966086
Page 144 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Did this s
erious ev
ent requir
e or prolo
ng hospit
alization?
NO
Did this s
erious ev
ent result
in persist
ent or sig
nificant d
isability/i
ncapacity
?
NO
Is this ser
ious even
t life thre
atening?
NO
Other me
dically i
mportant
serious e
vent
YES
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966087
Page 145 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Nov-06-2020
09:14:19
(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
Nov-17-2020
19:30:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966088
Page 146 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-17-2020
16:54:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Katherine Liau Query
1: Clos
edResponse satisfies query
Nov-17-2020
16:25:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredChanged Information
Nov-17-2020
16:25:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s),
this e
vent i
s due
to:
OT
HE
RChanged Information
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966089
Page 147 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
If
Ot
her
, s
pe
cif
y:
S
e
x
u
al
I
n
te
r
c
o
u
rs
e
Nov-17-2020
16:24:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredSexual Intercourse
Nov-17-2020
05:23:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Open
edSAE
RECON:AER#2020433197,causality
was recorded as RELATED in AE
CRF.Per narrative of the case The
investigator considered there was
NOT a reasonable possibility that the
event was related to any clinical trial
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966090
Page 148 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
procedure.Please update as
appropriate.
Nov-16-2020
18:39:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Katherine Liau Query
1: Reiss
ued:Op
enedGPD CLIN: Study relation is in
reference to event of pregnancy.
Please review and update causality
as soon as possible. Thank you.
Nov-16-2020
14:50:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredRelated
Nov-15-2020
12:59:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Reiss
ued:Op
enedCLINICAL - drug exposure during
pregnancy is NOT reported as
related to itself (so NOT
RELATED). Any later issue with the
pregnancy or baby would be reported
as a separate event, and relationship
assessed for that.
Nov-13-2020
15:31:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredThe PI is unsure how to assess this
as the pregnancy at this point is
normal and the outcome is unknown.
Should it be assessed as related to
IP?
Nov-13-2020
13:10:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Reiss
ued:Op
enedCLINICAL - Thank you. As both
Pregnancy and study Drug Exposure
are in the term, the causality is not
related to those 2 events themselves;
ie PG would not be related to PG.
Please review, and update as
appropriate.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966091
Page 149 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-11-2020
15:59:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredThe PI has assessed a causal
relationship to IP in this case. As this
subject would not have had
"exposure during pregnancy" had
she not been vaccinated with IP. We
are open to changing the response if
needed.
Nov-11-2020
11:23:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
1: Reiss
ued:Op
enedCLINQUERY: The question is
asking in regard to whether the study
treatment had a causal relationship to
the event (pregnancy). Please review
if current entry is correct
Nov-10-2020
16:59:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredplease advise how this should be
assessed
Nov-10-2020
06:54:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
1: Open
edCLINQUERY: Exposure during
Pregnancy has been reported as
Related to study treatment. Please
review and update as appropriate
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
RELAT
EDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966092
Page 150 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020
06:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0966093
Page 151 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-12-2020
02:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020
16:17:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Please advise? as
there is not an end
date but the subject
is still pregnant so is
still marked yes.
Nov-11-2020
16:00:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE
EXPOSURE
DURING
PREGNANCY:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Nov-11-2020
16:00:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Updated per query.
Nov-11-2020
16:00:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNUpdated per query.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966094
Page 152 of 158
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-11-2020
05:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020433197,
the outcome in AE
CRF was reported
as NOT
RECOVERED/NOT
RESOLVED.Based
on the latest EDP
guidance, outcome
should be recorded
as UNKNOWN.
Please confirm and
update accordingly.
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020
09:14:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966095
Page 153 of 158
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-06-2020
09:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020
09:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020
09:10:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-06-2020
09:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is
PREGNANCY
but "Specify
Status" is
Provided.
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966096
Page 154 of 158
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-06-2020
09:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-06-2020
09:10:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Nov-06-2020
09:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
IP Permanently withdr
awn as it was discover
ed on 05NOV2020 that
subject is pregnantInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966097
Page 155 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021
14:45:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966098
Page 156 of 158
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-19-2021
14:47:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willi
ng to return for Vaccinat
ion 3 OR otherwise not e
ligibleInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966099
Page 157 of 158
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-06-2020
09:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-19-2020
10:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Oct-19-2020
10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-06-2020
09:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
Oct-19-2020
10:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Oct-19-2020
10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966100
Page 158 of 158
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871557 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Mar-05-2021
15:33:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Kevin
CannonData Entry:
Click Here to EnableInitial Entry
090177e196ae403a\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0966101