125742 S1 M5 CRF c4591001 1171 11711045

Document text

Page 1 of 213
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944790
Page 2 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944791
Page 3 of 213
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11711045]
2.Birth Date: /1946
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944792
Page 4 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944793
Page 5 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944794
Page 6 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944795
Page 7 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pulmonary Fibrosis]
Start Date: Aug/17/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTRIC SLEEVE]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944796
Page 8 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTRIC BYPASS]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIP REPLACEMENT (LEFT)]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SHOULDER REPLACEMENT (LEFT)]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944797
Page 9 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANKLE REPLACEMENT (RIGHT)]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CERVICAL SPINAL FUSION SURGERY]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944798
Page 10 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hot Flashes]
Start Date: UNK/UNK/1986
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cough]
Start Date: UNK/UNK/2019
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944799
Page 11 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [137.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [25.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944800
Page 12 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944801
Page 13 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [230292]
3.Randomization Group: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944802
Page 14 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP0YW0]
5.bSample ID [BP0YW1]
5.cSample ID [BP0YW2]
5.dSample ID [BPHHD3]
5.eSample ID [BPHHD4]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944803
Page 15 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP0Z41]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944804
Page 16 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/17/2020 15:47
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
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944805
Page 17 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944806
Page 18 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944807
Page 19 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944808
Page 20 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944809
Page 21 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0ZBH]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944810
Page 22 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 13:50
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
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944811
Page 23 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944812
Page 24 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BP9NK0]
5.bSample ID [BP9NK1]
5.cSample ID [BP9NK2]
5.dSample ID [BRTTC0]
5.eSample ID [BRTTC1]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944813
Page 25 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944814
Page 26 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944815
Page 27 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944816
Page 28 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944817
Page 29 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944818
Page 30 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944819
Page 31 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944820
Page 32 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944821
Page 33 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944822
Page 34 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944823
Page 35 of 213
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944824
Page 36 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944825
Page 37 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944826
Page 38 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944827
Page 39 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Perforated Intestinal m
arginated Ulcer Jan/31/202
1 00:00 NO
End Date Time:
Jan/31/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944828
Page 40 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Perforated Intestinal marginated Ulcer]
4.Start Date Time: Jan/31/2021 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/31/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944829
Page 41 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[N/A]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2021149075]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944830
Page 42 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944831
Page 43 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944832
Page 44 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944833
Page 45 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944834
Page 46 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944835
Page 47 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944836
Page 48 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944837
Page 49 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944838
Page 50 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944839
Page 51 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944840
Page 52 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944841
Page 53 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944842
Page 54 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944843
Page 55 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vaccination
1.Was there a temporary delay
of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944844
Page 56 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944845
Page 57 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944846
Page 58 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944847
Page 59 of 213
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to return
for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944848
Page 60 of 213
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944849
Page 61 of 213
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944850
Page 62 of 213
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944851
Page 63 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944852
Page 64 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944853
Page 65 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944854
Page 66 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944855
Page 67 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944856
Page 68 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9PDZ]
5.bSample ID [BP9PF0]
5.cSample ID [BP9PF1]
5.dSample ID [BLG55R]
5.eSample ID [BLG55S]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944857
Page 69 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9PF2]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944858
Page 70 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 11:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944859
Page 71 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944860
Page 72 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944861
Page 73 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2Z9S]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944862
Page 74 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 14:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944863
Page 75 of 213
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944864
Page 76 of 213
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944865
Page 77 of 213
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944866
Page 78 of 213
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944867
Page 79 of 213
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944868
Page 80 of 213
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944869
Page 81 of 213
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT
- UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944870
Page 82 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944871
Page 83 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944872
Page 84 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Earl Martin  Approved Mar-03-2021 11:27:09 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, 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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944873
Page 85 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-17-2020 14:52:41 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944874
Page 86 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-19-2021 12:54:35 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944875
Page 87 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944876
Page 88 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944877
Page 89 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944878
Page 90 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944879
Page 91 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944880
Page 92 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Jan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944881
Page 93 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944882
Page 94 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944883
Page 95 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aJan-19-2021 12:56:16 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944884
Page 96 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormFeb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944885
Page 97 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Feb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944886
Page 98 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Feb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944887
Page 99 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Feb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944888
Page 100 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Feb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944889
Page 101 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Feb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944890
Page 102 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aFeb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944891
Page 103 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aFeb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944892
Page 104 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aFeb-10-2021 18:34:35 (UTC-06:00)
Central Time (US & Canada)Subject not of childbearing potential
Not Done
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944893
Page 105 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Earl Martin  Approved Mar-03-2021 11:27:09 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend
that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-10-2021 18:34:11 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Jan-28-2021 11:40:57 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, 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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944894
Page 106 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
 N/A Jan-16-2021 12:54:42 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Oct-20-2020 15:42:39 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, 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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944895
Page 107 of 213
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020
14:50:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020
14:50:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944896
Page 108 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020
14:50:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/17/2020Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944897
Page 109 of 213
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020
14:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11711045Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020
14:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1946Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020
14:51:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020
14:51:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944898
Page 110 of 213
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020
14:51:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944899
Page 111 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020
14:52:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944900
Page 112 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-17-2020
14:53:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020
14:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020
14:53:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944901
Page 113 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020
14:54:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Pulmonary
Fibrosis
Start Date: Aug/17/20
00
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020
14:54:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020
11:56:26
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Aug-18-2020
11:48:21
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000  Mueed Bari Query 1: Answered Subject has
been stable, per
PI.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944902
Page 114 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Canada)
Aug-18-2020
11:31:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Please clarify if
the disease has
been stable
during the 6
weeks before
enrollment.
Aug-17-2020
14:54:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Pulmonary FibrosisInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020
14:54:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-17-2020
14:54:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944903
Page 115 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-17-2020
14:54:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:HYPERTE
NSION
Start Date: UNK/UN
K/2005
Ongoing: YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944904
Page 116 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-17-2020
14:54:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
14:54:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-17-2020
14:54:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-17-2020
14:54:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944905
Page 117 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
14:55:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:GASTRIC S
LEEVE
Start Date: UNK/UNK/
2010
Ongoing: NO
End Date:
UNK/UN
K/2010Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944906
Page 118 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Aug-17-2020
14:55:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
14:55:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
GASTRIC SLEEVEInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-17-2020
14:55:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-17-2020
14:55:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.d
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944907
Page 119 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
14:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:GASTRIC B
YPASS
Start Date: Oct/UNK/20
19
Ongoing: NO
End Date:
Oct/UNK
/2019Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944908
Page 120 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Aug-17-2020
14:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
14:58:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
GASTRIC BYPASSInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-17-2020
14:58:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-17-2020
14:58:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/UNK/2019Initial Entry
1.e
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944909
Page 121 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
15:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:HIP REPLAC
EMENT (LEF
T)
Start Date
:UNK/UNK/20
10
Ongoing: NO
End Date:
UNK/UNK/
2010Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944910
Page 122 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.e Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
15:00:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
HIP REPLACEMENT (
LEFT)Initial Entry
1.e Start Date:
Date Location User Value Reason
Aug-17-2020
15:00:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-17-2020
15:00:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.f
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944911
Page 123 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
15:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History
Term:SHOULDER R
EPLACEMENT
(LEFT)
Start Da
te:UNK/UNK/201
3
Ongoing
:NO
End Date:
UNK/UNK/2
013Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944912
Page 124 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
15:00:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
SHOULDER REPLACE
MENT (LEFT)Initial Entry
1.f Start Date:
Date Location User Value Reason
Aug-17-2020
15:00:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-17-2020
15:00:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.g
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944913
Page 125 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
15:01:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:ANKLE REPL
ACEMENT (RI
GHT)
Start Dat
e:UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944914
Page 126 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.g Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:01:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
15:01:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ANKLE REPLACEME
NT (RIGHT)Initial Entry
1.g Start Date:
Date Location User Value Reason
Aug-17-2020
15:01:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-17-2020
15:01:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.h
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944915
Page 127 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
17:13:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:8
Medica
l Histor
y Term
:CERVICAL S
PINAL FUSI
ON SURGER
Y
Start D
ate:UNK/UNK/20
16
Ongoin
g:NO
End Date:
UNK/UNK
/2016Changed
Information
Aug-17-2020
15:01:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:8
Medical
History
Term:CERVICAL
SPINAL FU
SION
Start Da
te:UNK/UNK/2
016
Ongoing
:NO
End Date:
UNK/UN
K/2016Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944916
Page 128 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.h Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-17-2020
19:36:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Aug-17-2020
17:13:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged
Information
Aug-17-2020
17:13:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
CER
VICA
L SPI
NAL
FUSI
ON S
URG
ERYChanged
Information
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944917
Page 129 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-17-2020
17:03:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify as
follows..
CERVICAL
SPINAL
FUSION, if
reporting a
surgical
fusion edit
to state
"procedure',
"surgery",
"operation"
"surgical"
etc..
Aug-17-2020
15:01:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
CER
VICA
L SPI
NAL
FUSI
ONInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-17-2020
15:01:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944918
Page 130 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-17-2020
15:01:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.i
Date Location User Value Reason
Aug-17-2020
15:02:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:HYSTEREC
TOMY
Start Date: UNK/UNK/
1986
Ongoing: NO
End Date:
UNK/UN
K/1986Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944919
Page 131 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:02:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
15:02:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMYInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-17-2020
15:02:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1986Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-17-2020
15:02:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1986Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944920
Page 132 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.j
Date Location User Value Reason
Aug-17-2020
15:02:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:Hot Flashe
s
Start Date: UNK/UN
K/1986
Ongoing: YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944921
Page 133 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.j Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:02:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
15:02:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Hot FlashesInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-17-2020
15:02:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1986Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-17-2020
15:02:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944922
Page 134 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
15:03:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:Cough
Start Date: UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944923
Page 135 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.k Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:03:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020
11:56:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Aug-18-2020
11:50:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Mueed Bari Query 1: Answered Symptom is
associated with
participant's
pulmonary
fibrosis, and has
been stable in
the past 6
weeks, per Sub
I.
Aug-18-2020
11:35:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Please clarify if
1)this symptom
is associated
with
participant's
pulmonary
fibrosis or is
related to
another disease
diagnosis; 2) if
it has been
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944924
Page 136 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
stable in the past
6 weeks.
Aug-17-2020
15:03:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
CoughInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-17-2020
15:03:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-17-2020
15:03:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-17-2020
15:05:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:Osteoarthr
itisInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944925
Page 137 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: UNK/UN
K/2005
Ongoing: YES
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944926
Page 138 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.l Line/MH Number:
Date Location User Value Reason
Aug-17-2020
15:05:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
15:05:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OsteoarthritisInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-17-2020
15:05:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-17-2020
15:05:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944927
Page 139 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
137.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000  Data Entry:
61.0Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944928
Page 140 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Canada)
5. Unit:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.9Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 97.7
Temperature
Unit:F
Temperature
Location::FOREH
EADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020
15:34:41ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944929
Page 141 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time (US &
Canada)
7.a Temperature:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020
15:34:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944930
Page 142 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944931
Page 143 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonad
otropin Beta_
PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Bet
a_PX113Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944932
Page 144 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time (US &
Canada)
6.a Not Done:
Date Location User Value Reason
Aug-17-2020
15:35:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944933
Page 145 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020
15:35:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020
15:35:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
230292Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944934
Page 146 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020
16:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020
16:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020
16:13:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-17-2020
16:13:52
(UTC-06:00) Central
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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944935
Page 147 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-17-2020
16:13:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020
16:13:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0YW0Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
16:13:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0YW0Initial Entry
5.b
Date Location User Value Reason
Aug-17-2020
16:14:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0YW1Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944936
Page 148 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Sample ID
Date Location User Value Reason
Aug-17-2020
16:14:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0YW1Initial Entry
5.c
Date Location User Value Reason
Aug-17-2020
16:14:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0YW2Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020
16:14:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0YW2Initial Entry
5.d
Date Location User Value Reason
Aug-17-2020
16:14:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BPHHD3Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944937
Page 149 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Aug-17-2020
16:14:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BPHHD3Initial Entry
5.e
Date Location User Value Reason
Aug-17-2020
16:14:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BPHHD4Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020
16:14:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BPHHD4Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944938
Page 150 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020
16:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020
16:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020
16:07:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-17-2020
16:07:17
(UTC-06:00)
Central 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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944939
Page 151 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-17-2020
16:07:17
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020
16:07:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0Z41Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
16:07:21
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP0Z41Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944940
Page 152 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Aug/17/2020 15:47Initial Entry
5. Anatomical Location:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944941
Page 153 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-17-2020
16:19:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Aug-17-2020
16:19:00ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944942
Page 154 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944943
Page 155 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-09-2020
03:28:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Data updated per
query
Sep-03-2020
08:33:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020
08:33:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTTranscription Error
Sep-03-2020
04:47:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-17-2020 ACV0PFEINFP6000  Mueed Bari Data Entry: Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944944
Page 156 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
16:14:19
(UTC-06:00)
Central Time (US
& Canada)YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECT
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944945
Page 157 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020
14:17:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sep/8/2020Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944946
Page 158 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020
15:30:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020
15:30:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Record Identifi
er::1
Temperature: 97.5
Temperature U
nit:F
Temperature L
ocation::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020
15:30:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020
15:30:10ACV0PFEINFP6000  Mueed Bari Data Entry:
97.5Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944947
Page 159 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)
2.a Unit:
Date Location User Value Reason
Sep-08-2020
15:30:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020
15:30:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FOREHEADInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944948
Page 160 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944949
Page 161 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonad
otropin Beta_
PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Choriogonadotropin Beta_
PX113Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944950
Page 162 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6.a Not Done:
Date Location User Value Reason
Sep-08-2020
15:30:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOT DONEInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944951
Page 163 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020
15:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020
15:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
15:30:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
15:30:34
(UTC-06:00)
Central 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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944952
Page 164 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-08-2020
15:30:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
15:30:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP0ZBHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
15:30:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP0ZBHInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944953
Page 165 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sep/8/2020 13:50Initial Entry
5. Anatomical Location:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944954
Page 166 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020
15:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-08-2020
15:31:04ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944955
Page 167 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944956
Page 168 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
13:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Oct/6/2020Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944957
Page 169 of 213
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
15:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
15:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
15:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
15:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-06-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944958
Page 170 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
15:33:51
(UTC-06:00) Central
Time (US & Canada)YES
Date of Collection:
Oct/6/2020
5.a
Date Location User Value Reason
Oct-06-2020
15:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9NK0Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
15:34:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9NK0Initial Entry
5.b
Date Location User Value Reason
Oct-06-2020
15:34:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9NK1Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020
15:34:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9NK1Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944959
Page 171 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c
Date Location User Value Reason
Oct-06-2020
15:34:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9NK2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020
15:34:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9NK2Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020
15:34:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTTC0Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-06-2020
15:34:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTTC0Initial Entry
5.e
Date Location User Value Reason
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944960
Page 172 of 213
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-06-2020
15:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTTC1Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-06-2020
15:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTTC1Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944961
Page 173 of 213
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-07-2020
09:46:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020
09:46:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020
09:46:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944962
Page 174 of 213
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944963
Page 175 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00) Central
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
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Perforated Intestinal mar
ginated UlcerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 00:00Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944964
Page 176 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/31/2021 UNK:UN
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-09-2021
12:48:17
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Ok Thanks.
Mar-09-2021
12:35:03
(UTC-06:00)ACV0PFEINFP6000  Query 2: Answered Medical records
have been
requested a
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944965
Page 177 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time (US &
Canada)second time,
information
pending
Feb-25-2021
17:21:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Reissued:Open
edThanks for
confirming.
Please provide a
future date for a
FUp so I can
close the query
Feb-19-2021
10:22:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered Medical records
have been
requested, data
will be updated
once available
Feb-17-2021
05:16:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened Medical
Monitor_ Pls
provide further
details on
clinical
presentation,
workup
performed and
treatment
received in a FU
form so this
information is
added to the
safety report.
Thanks.
Feb-16-2021
23:56:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944966
Page 178 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Perforated
Intestinal
marginated
Ulcer: Response
to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event as
sociated with congenit
al anomaly or birth def
ect?
NO
Did this serious event
result in death?
NO
Did this serious event
require or prolong hos
pitalization?
YES
Did this serious event
result in persistent or s
ignificant disability/in
capacity?
NOInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944967
Page 179 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Is this serious event lif
e threatening?
NO
Other medically impor
tant serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-16-2021
16:04:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-09-2021
14:26:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Mar-09-2021
11:59:09
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Per PI -
Awaiting
medical records.
Unlikely to be
related, due to
location of
perforation.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944968
Page 180 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-03-2021
15:53:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Causality is
noted as NA.
However, NA
does not explain
the most likely
cause of the AE.
Please clarify
the cause of
Perforated
Intestinal
Marginated
Ulcer and
update the CRF
as appropriate.
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:
N/AInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944969
Page 181 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021
20:37:32
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Closed Response
satisfies query
Feb-22-2021
09:37:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed
Information
Feb-22-2021
09:37:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESChanged
Information
Feb-21-2021
15:40:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Opened GPDClin: Per
SAE report, a
surgery was
performed. If
yes, please
change the
answer to "Yes".
Feb-18-2021
12:37:48ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944970
Page 182 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time (US &
Canada)
Feb-18-2021
11:36:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-18-2021
11:36:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription
Error
Feb-16-2021
23:45:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Was a
Non-Drug
Treatment
given?" is
missing. Kindly
review and
update.
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944971
Page 183 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-16-2021
16:04:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-16-2021
23:56:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021149075Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944972
Page 184 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-16-2021
12:54:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944973
Page 185 of 213
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-16-2021
12:54:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to r
eturn for Vaccination 3
Participant is:
eligible per local/natio
nal recommendations
and confirmed to have
received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944974
Page 186 of 213
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-16-2021
12:54:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-16-2021
12:54:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL VA
CCINATIONInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944975
Page 187 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
12:53:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944976
Page 188 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021
12:54:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent O
btained
Jan/19/2021Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944977
Page 189 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-19-2021
12:55:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 12:55:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021
12:55:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944978
Page 190 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944979
Page 191 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time (US &
Canada)
5. Specimen Type:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defin
ed Identifier:Not Ap
plicable
Test:: Not Ap
plicable
Result:: Not Ap
plicable
Not Done:: Not Ap
plicableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944980
Page 192 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-19-2021
12:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944981
Page 193 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 12:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 12:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021
12:57:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
12:56:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-19-2021
12:56:33ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944982
Page 194 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time (US &
Canada)Date of Collection:
Jan/19/2021
5.a
Date Location User Value Reason
Jan-19-2021
12:57:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9PDZInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021
12:57:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP9PDZInitial Entry
5.b
Date Location User Value Reason
Jan-19-2021
12:57:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9PF0Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944983
Page 195 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Sample ID
Date Location User Value Reason
Jan-19-2021
12:57:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP9PF0Initial Entry
5.c
Date Location User Value Reason
Jan-19-2021
12:57:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9PF1Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-19-2021
12:57:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP9PF1Initial Entry
5.d
Date Location User Value Reason
Jan-19-2021
12:57:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG55RInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944984
Page 196 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Jan-19-2021
12:57:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BLG55RInitial Entry
5.e
Date Location User Value Reason
Jan-19-2021
12:57:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG55SInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-19-2021
12:57:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BLG55SInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944985
Page 197 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 12:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 12:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021
12:57:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
12:57:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-19-2021
12:57:40ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944986
Page 198 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time (US &
Canada)Date of Collection:
Jan/19/2021
5.a
Date Location User Value Reason
Jan-19-2021
12:57:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9PF2Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021
12:57:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BP9PF2Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944987
Page 199 of 213
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-19-2021
12:58:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-19-2021
12:58:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 11:52Initial Entry
5. Anatomical Location:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944988
Page 200 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021
12:58:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944989
Page 201 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-19-2021 12:58:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Jan-19-2021
12:58:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944990
Page 202 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
18:34:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944991
Page 203 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944992
Page 204 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time (US &
Canada)
5. Specimen Type:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Define
d Identifier:Not D
one
Test:: Not D
one
Result:: Not D
one
Not Done:: Not D
oneInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944993
Page 205 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-10-2021
18:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944994
Page 206 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
18:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
18:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
18:35:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
18:34:52
(UTC-06:00)
Central 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.
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944995
Page 207 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-10-2021
18:34:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
18:35:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2Z9SInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
18:35:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BR2Z9SInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944996
Page 208 of 213
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021 14:03Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944997
Page 209 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944998
Page 210 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Feb-10-2021
18:35:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944999
Page 211 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-07-2020
09:46:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-17-2020
15:35:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZ
EDInitial Entry
Aug-17-2020
14:53:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-16-2021
23:56:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-16-2021
16:04:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answe
redChanged data per query
Feb-15-2021
04:54:12
(UTC-06:00)ACV0PFEINFP6000  Query 1: Opene
dSAE
RECON:AER#2021149075
perforated intestional
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945000
Page 212 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time
(US & Canada)marginated ulcer(onset
date:31Jan2021)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Oct-07-2020
09:46:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Aug-17-2020
15:35:43
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
Aug-17-2020
14:53:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945001
Page 213 of 213
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020
15:11:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d4c\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945002