125742 S1 M5 CRF c4591001 1157 11571134

Document text

Page 1 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841955
Page 2 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
Sep/2/2020
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841956
Page 3 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11571134]
2.Birth Date: 1951
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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841957
Page 4 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841958
Page 5 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841959
Page 6 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841960
Page 7 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:[Depression]
Start Date: Jan/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Osteoarthritis Multiple Joints]
Start Date: UNK/UNK/2004
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Post Menopause]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841961
Page 8 of 131
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [141.0]
3.Unit: LB
4.Height: [64.75]
5.Unit: in
6.Body Mass Index: [23.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841962
Page 9 of 131
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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/2/2020
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
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841963
Page 10 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249134]
3.Randomization Group: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841964
Page 11 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
Sep/2/2020
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 [BP1WBY]
5.bSample ID [BP1WBZ]
5.cSample ID [BP1WC0]
5.dSample ID [BLC2CS]
5.eSample ID [BLC2CT]
5 fSample ID [BLC2CV]
5.gSample ID [BLC2CW]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841965
Page 12 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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/2/2020
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 [BP1WKM]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841966
Page 13 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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/2/2020 09:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841967
Page 14 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841968
Page 15 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841969
Page 16 of 131
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841970
Page 17 of 131
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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/24/2020
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
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841971
Page 18 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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/24/2020
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 [BP1WR5]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841972
Page 19 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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/24/2020 09:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841973
Page 20 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841974
Page 21 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
Nov/5/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR842P]
5.bSample ID [BR842R]
5.cSample ID [BR842S]
5.dSample ID [BPM0FV]
5.eSample ID [BPM0FW]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841975
Page 22 of 131
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841976
Page 23 of 131
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841977
Page 24 of 131
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841978
Page 25 of 131
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841979
Page 26 of 131
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841980
Page 27 of 131
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841981
Page 28 of 131
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841982
Page 29 of 131
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841983
Page 30 of 131
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841984
Page 31 of 131
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841985
Page 32 of 131
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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?
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841986
Page 33 of 131
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841987
Page 34 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841988
Page 35 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841989
Page 36 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841990
Page 37 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841991
Page 38 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841992
Page 39 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841993
Page 40 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841994
Page 41 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841995
Page 42 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Suspected Transient Ischemi
c Attack Oct/27/2020 05:30  NO
End Date Time:
Oct/28/2020 14:00
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Tremor  Oct/13/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841996
Page 43 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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)[Suspected Transient Ischemic Attack]
4.Start Date Time: Oct/27/2020 05:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 14:00
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
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:
[Atherosclerotic vs Embolic disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841997
Page 44 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020419861]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841998
Page 45 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Tremor]
4.Start Date Time: Oct/13/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841999
Page 46 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842000
Page 47 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842001
Page 48 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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[ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842002
Page 49 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842003
Page 50 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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: //
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842004
Page 51 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842005
Page 52 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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?
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842006
Page 53 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842007
Page 54 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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?
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842008
Page 55 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842009
Page 56 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842010
Page 57 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842011
Page 58 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842012
Page 59 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842013
Page 60 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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?
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842014
Page 61 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842015
Page 62 of 131
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842016
Page 63 of 131
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842017
Page 64 of 131
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842018
Page 65 of 131
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842019
Page 66 of 131
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842020
Page 67 of 131
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842021
Page 68 of 131
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842022
Page 69 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842023
Page 70 of 131
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842024
Page 71 of 131
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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: [ ]
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842025
Page 72 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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 Nov/5/2020
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842026
Page 73 of 131
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842027
Page 74 of 131
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842028
Page 75 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-02-2020 12:03:02 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842029
Page 76 of 131
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-08-2021 11:16:15 (UTC-08:00) Pacific Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jamshid Saleh  Approved Nov-13-2020 13:55:38 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JamshidSaleh, 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.
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842030
Page 77 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
Sep-02-2020 12:02:15
(UTC-08:00) Pacific 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
Sep-02-2020 12:02:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842031
Page 78 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 12:02:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842032
Page 79 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-03-2020 06:54:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed reissued in AE LOG
Oct-31-2020 07:10:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened SAE RECON 1: In safety
database 'suspected
transient ischemic attack'
was recorded as separate
entry from CVA. Please
confirm if this is indeed a
separate SAE that and
should be added in AE
CRF.Otherwise,please
submit a follow up AEM
form to clarify event
Oct-31-2020 07:08:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Cerebrovascular attack
added in AE CRF
Oct-30-2020 08:47:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered AE has been entered
Oct-30-2020 08:47:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Ae has been entered
Oct-30-2020 05:24:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020419861
suspected transient
ischemic attack(onset
date:27Oct2020)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-29-2020 04:06:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020419861
suspected
stroke/CVA(onset
date:27Oct2020)was
reported as serious in
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842033
Page 80 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-02-2020 12:02:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11571134Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 11:57:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 12:02:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 12:02:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020 12:02:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842034
Page 81 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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-02-2020 12:02:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842035
Page 82 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020 12:03:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 12:03:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 12:03:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842036
Page 83 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 12:03:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:Depression
Start Date: Jan/UNK/202
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 12:03:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 13:12:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-08-2020 09:51:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered This is ongoing, per PI
this did not meet
exclusion 1. Subject is
taking medication to
keep this condition
stable
Sep-04-2020 11:30:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Depression is noted
from Jan2020 to
ongoing. Please
confirm if this Medhx
is truly ongoing and if
the subject meets
Exclusion 1 as per the
PI's assessment, then
update the CRF as
appropriate.
Sep-02-2020 12:03:39
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842037
Page 84 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
1.a Start Date:
Date Location User Value Reason
Sep-02-2020 12:03:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 12:03:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-02-2020 12:07:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Osteoarthritis Multi
ple Joints
Start Date: UNK/UNK/2004
Ongoing: YESInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842038
Page 85 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 12:07:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 12:07:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Osteoarthritis Multiple JointsInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 12:07:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 12:07:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-02-2020 12:07:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Post Menopaus
e
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842039
Page 86 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020 12:07:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 06:05:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Nov-03-2020 14:40:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Follow up SAE to be
submitted today
Oct-30-2020 12:35:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened If test was NOT done
or NOT available,
please summit FU
report so this
information is added
to the case narrative as
well. Thanks
Oct-30-2020 08:50:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered No Covid testing was
done at the hospital
Oct-30-2020 07:57:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Kindly confirm if any
SARS-CoV-2 (NAAT
or other) tests were
performed on the SAE
submitted to safety. If
test performed = YES,
please provide FU
report with results. If
test was NOT done or
NOT available, please
FU as well. Thanks
Sep-02-2020 12:07:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Post MenopauseInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020 12:07:31
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0842040
Page 87 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020 12:07:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842041
Page 88 of 131
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
141.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
64.75Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.6Initial Entry
7.a
Date Location User Value Reason
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842042
Page 89 of 131
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.2
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 12:08:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842043
Page 90 of 131
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842044
Page 91 of 131
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020 13:52:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842045
Page 92 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020 13:52:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020 13:52:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
249134Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842046
Page 93 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 13:52:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 13:52:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 13:52:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 13:52:43
(UTC-08:00) Pacific 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.
Sep-02-2020 13:52:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 13:52:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1WBYInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 13:52:49
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BP1WBYInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0842047
Page 94 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
5.b
Date Location User Value Reason
Sep-02-2020 13:52:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1WBZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 13:52:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1WBZInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 13:53:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1WC0Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 13:53:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1WC0Initial Entry
5.d
Date Location User Value Reason
Sep-02-2020 13:53:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC2CSInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 13:53:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLC2CSInitial Entry
5.e
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842048
Page 95 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-02-2020 13:53:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC2CTInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 13:53:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLC2CTInitial Entry
5.f
Date Location User Value Reason
Sep-02-2020 13:54:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC2CVInitial Entry
5.f Sample ID
Date Location User Value Reason
Sep-02-2020 13:54:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLC2CVInitial Entry
5.g
Date Location User Value Reason
Sep-02-2020 13:54:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC2CWInitial Entry
5.g Sample ID
Date Location User Value Reason
Sep-02-2020 13:54:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLC2CWInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842049
Page 96 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 13:54:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 13:54:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 13:55:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 13:54:23
(UTC-08:00) Pacific 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.
Sep-02-2020 13:54:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 10:16:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1WKMTranscription Error
Sep-02-2020 13:55:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1WKSInitial Entry
5.a Sample ID
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842050
Page 97 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-09-2020
04:35:23
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Saumitra Dubey Query 2: Clo
sedSample ID is updated
to BP1WKM.
Sep-08-2020
13:00:56
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-08-2020
10:16:11
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Ans
weredTranscription Error
Sep-08-2020
10:16:11
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription Error
Sep-08-2020
10:16:11
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1WKMTranscription Error
Sep-08-2020
01:20:11
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Saumitra Dubey Query 2: Op
enedLIMS Query: As per
lab, sample ID is
BP1WKM and not
BP1WKS as reported
here. Please check
and correct the data,
else clarify.
Sep-03-2020
00:21:12
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Op
enedDMW4593536;The
barcode BP1WKS is
recorded for two
subjects 11571134
and 11571135, please
review and update as
appropriate.
Sep-02-2020
13:55:05
(UTC-08:00)
Pacific TimeACV0PFEINFP6000  Data Entry:
BP1WKSInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0842051
Page 98 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842052
Page 99 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 09:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842053
Page 100 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-02-2020 13:55:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842054
Page 101 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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-02-2020 13:55:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842055
Page 102 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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-28-2020 22:49:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 08:35:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-28-2020 08:35:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
Sep-26-2020 03:41:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete ‘Date of
Visit, Nasal Swab,
Pregnancy Test,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842056
Page 103 of 131
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 08:36:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020 08:36:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.8
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 08:36:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-28-2020 08:36:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020 08:36:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 08:36:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842057
Page 104 of 131
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842058
Page 105 of 131
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-28-2020 08:42:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842059
Page 106 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 08:43:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 08:43:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 08:43:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 08:43:31
(UTC-08:00) Pacific 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.
Sep-28-2020 08:43:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 08:43:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1WR5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 08:43:38
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BP1WR5Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0842060
Page 107 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0842061
Page 108 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 09:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842062
Page 109 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-28-2020 08:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842063
Page 110 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-09-2020
22:38:41
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedClosed per SITE response,
added to PD tracker for
Clinical Review
Nov-09-2020
12:02:02
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredVisit was done on 05 Nov
2020 OOW due to the subject
having an SAE of TIA and not
feeling capable of coming in
for a Visit 3 at the originally
scheduled visit on 30 Oct 2020
Nov-06-2020
23:32:52
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 7 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Nov-06-2020
09:05:53
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Nov/5
/2020Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0842064
Page 111 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 09:06:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 09:06:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 09:17:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 09:06:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-06-2020 09:06:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020 09:17:44
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR842PInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 09:17:44
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BR842PInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0842065
Page 112 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
5.b
Date Location User Value Reason
Nov-06-2020 09:17:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR842RInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020 09:17:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR842RInitial Entry
5.c
Date Location User Value Reason
Nov-06-2020 09:17:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR842SInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020 09:17:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR842SInitial Entry
5.d
Date Location User Value Reason
Nov-06-2020 09:19:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPM0FVInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-06-2020 09:19:07
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPM0FVInitial Entry
5.e
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842066
Page 113 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-06-2020 09:19:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPM0FWInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-06-2020 09:19:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPM0FWInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842067
Page 114 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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
Nov-06-2020 09:19:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020 09:19:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020 09:19:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842068
Page 115 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842069
Page 116 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842070
Page 117 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-07-2020 07:52:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-06-2020 09:37:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-06-2020 09:37:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Suspected Transient Ischemic AttackNew Information
Nov-06-2020 03:37:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1: The
event term in Safety
database was retained
as'suspected transient
ischemic attack' while
recorded as
Cerebrovascular attack
in AE CRF. Please
confirm correct term
and update accordingly.
Nov-04-2020 03:02:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate SAE recon: pending
SDB update
Nov-03-2020 14:39:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered These are not separate
SAEs a follow up SAE
will be submitted today
with updated SAE term
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842071
Page 118 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-03-2020 06:55:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:In safety
database 'suspected
transient ischemic
attack' was recorded as
separate entry from
CVA. Please confirm if
this is indeed a separate
SAE that and should be
added in AE
CRF.Otherwise,please
submit a follow up
AEM form to clarify
events
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Cerebrovascular AttackInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020 05:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-30-2020 08:46:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/28/2020 14:00New Information
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842072
Page 119 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
Oct-31-2020 07:07:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Cerebrovascular
Attack: Response to "Is
the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
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 prol
ong hospitalization?
YES
Did this serious event result in persis
tent or significant disability/incapaci
ty?
NO
Is this serious event life threatening?
NO
Other medically important serious e
vent
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842073
Page 120 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
Atherosclerotic vs Embolic disea
seInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-30-2020 08:46:50 ACV0PFEINFP6000  auto query Query 1: Closed Close Auto Query
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842074
Page 121 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-08:00) Pacific Time
(US & Canada)(autoquery)
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Cerebrovascular
Attack: Response to
"What was the
outcome of this
adverse event?" is 3
but End Date/Time is
missing.
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-30-2020 08:46:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-31-2020 07:07:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020419861Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842075
Page 122 of 131
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TremorInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-04-2021 07:34:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-21-2020 09:02:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered This is an ongoing
medical condition not
foreseen to resolve
Dec-15-2020 08:22:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
verify if Tremor is
ongoing, then update
the END DATE and
OUTCOME as
appropriate.
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842076
Page 123 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-11-2020 11:58:00
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Nov-11-2020 11:23:02
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered The suspected
Conmed is Cymbalta
Nov-09-2020 14:44:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
specify which
ConMed was the
suspected cause of
this AE.
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0842077
Page 124 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
CONCOMITANT DRUG TREAT
MENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 12:24:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-11-2020 12:16:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842078
Page 125 of 131
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-11-2020 11:21:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Nov-11-2020 11:21:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-11-2020 11:21:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Nov-10-2020 19:57:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Did the adverse event
cause the subject to be
discontinued from the
study? = YES,
however, the FUP
page for this subject is
not completed. Please
clarify if subject
discontinued from
study and if so
complete FUP page or
else clarify.
Nov-10-2020 12:25:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Study
Discontinuation is
marked Yes. This field
should only be
checked Yes if the
subject will no longer
be followed up on.
The EOT notes
COMPLETED &
Follow Up Disposition
CRF is blank. Please
review update the CRF
as appropriate
Nov-05-2020 16:39:34
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842079
Page 126 of 131
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 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-08-2021 11:16:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842080
Page 127 of 131
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 10:14:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vacc
ination 3
Participant is:
eligible and NOT confirmed to hav
e received only placebo at Vaccinat
ion 1/2Transcription Error
Feb-08-2021 11:16:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to return fo
r Vaccination 3 OR otherwise not eligi
bleInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842081
Page 128 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-08-2021 11:16:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-24-2021
21:54:58
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Cl
osedAuto closed by
Validation Check:
VC_DS001_35
Feb-24-2021
10:14:51
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: A
nsweredChanged data per query
Feb-24-2021
01:50:47
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Re
issued:Open
edDM: Revax contact
form is unfrozen,
kindly review and
update.
Feb-23-2021
12:19:30
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: A
nsweredForm is still frozen
Feb-23-2021
08:38:53
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Re
issued:Open
edrevax contact form is
unfrozen please update.
Thank you
Feb-22-2021
14:17:09
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: A
nsweredPlease unlock revax
contact form to be
updated
Feb-22-2021
12:51:36
(UTC-08:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: O
penedDMW7350366;Primary
Reason for Unblinding
is "ASSESS
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0842082
Page 129 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Pacific Time
(US & Canada)ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-08-2021
11:16:15
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
ASSESS E
LIGIBILIT
Y FOR AD
DITIONAL
VACCINAT
IONInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842083
Page 130 of 131
***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: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-06-2020 09:19:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-02-2020 13:52:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-02-2020 12:03:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-06-2020 09:19:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
Sep-02-2020 13:52:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
Sep-02-2020 12:03:14
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842084
Page 131 of 131
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1157 Site Name: (1157) Paradigm Research
Subject No: 11571134 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-13-2020 13:55:25
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Jamshid
SalehData Entry:
Click Here to EnableInitial Entry
090177e196ae3039\Final\Final On: 01-Apr-2021 04:05 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0842085