125742 S1 M5 CRF c4591001 1037 10371141

Document text

Page 1 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904119
Page 2 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904120
Page 3 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10371141]
2.Birth Date: /1958
3.Sex: FEMALE
4.Ethnicity: NOT REPORTED
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904121
Page 4 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904122
Page 5 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904123
Page 6 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904124
Page 7 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ARTHRITIS]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904125
Page 8 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPOKALEMIA]
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/2020
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ARTERIAL THROMBOSIS]
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
Feb/UNK/2020
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[LEFT TOTAL HIP REPLACEMENT]
Start Date: Jan/UNK/2019
Ongoing: NO
End Date:
Jan/UNK/2019
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904126
Page 9 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[UTERINE FIBROIDS]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CONGESTIVE HEART FAILURE]
Start Date: Feb/UNK/2020
Ongoing: YES
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904127
Page 10 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [69.4]
3.Unit: kg
4.Height: [170.2]
5.Unit: cm
6.Body Mass Index: [24.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904128
Page 11 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and
Address (Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904129
Page 12 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [251380]
3.Randomization Group: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904130
Page 13 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BLBBTZ]
5.bSample ID [BLBBV0]
5.cSample ID [BN5SG3]
5.dSample ID [BN5SG4]
5.eSample ID [BN5SG5]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904131
Page 14 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BN5SM4]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904132
Page 15 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/4/2020 12:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904133
Page 16 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904134
Page 17 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904135
Page 18 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904136
Page 19 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and
Address (Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904137
Page 20 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BM8SCC]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904138
Page 21 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/23/2020 10:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904139
Page 22 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904140
Page 23 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BS6LZF]
5.bSample ID [BLBBD7]
5.cSample ID [BKP264]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904141
Page 24 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904142
Page 25 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904143
Page 26 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904144
Page 27 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904145
Page 28 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904146
Page 29 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904147
Page 30 of 162
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904148
Page 31 of 162
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904149
Page 32 of 162
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904150
Page 33 of 162
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904151
Page 34 of 162
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904152
Page 35 of 162
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904153
Page 36 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904154
Page 37 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904155
Page 38 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904156
Page 39 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904157
Page 40 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904158
Page 41 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904159
Page 42 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904160
Page 43 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904161
Page 44 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904162
Page 45 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904163
Page 46 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904164
Page 47 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904165
Page 48 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904166
Page 49 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904167
Page 50 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904168
Page 51 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904169
Page 52 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904170
Page 53 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904171
Page 54 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904172
Page 55 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904173
Page 56 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904174
Page 57 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904175
Page 58 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904176
Page 59 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904177
Page 60 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904178
Page 61 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904179
Page 62 of 162
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904180
Page 63 of 162
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904181
Page 64 of 162
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904182
Page 65 of 162
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904183
Page 66 of 162
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904184
Page 67 of 162
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904185
Page 68 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904186
Page 69 of 162
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904187
Page 70 of 162
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904188
Page 71 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904189
Page 72 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904190
Page 73 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904191
Page 74 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-04-2020 12:02:37 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904192
Page 75 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904193
Page 76 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904194
Page 77 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904195
Page 78 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904196
Page 79 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904197
Page 80 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904198
Page 81 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904199
Page 82 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904200
Page 83 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-04-2020 12:10:30 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904201
Page 84 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904202
Page 85 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904203
Page 86 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904204
Page 87 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904205
Page 88 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904206
Page 89 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904207
Page 90 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904208
Page 91 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904209
Page 92 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-23-2020 16:41:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904210
Page 93 of 162
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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-23-2021 17:38:36 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Usdan  Approved Oct-26-2020 12:43:37 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaUsdan, 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.
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904211
Page 94 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020
12:01:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020
12:01:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904212
Page 95 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020
12:02:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/4/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904213
Page 96 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020
12:01:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10371141Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020
12:01:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1958Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020
12:02:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904214
Page 97 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020
12:02:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT REPORTEDInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020
12:02:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904215
Page 98 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020
12:02:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904216
Page 99 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020
12:03:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
ClosedClose Auto Query
Sep-04-2020
12:03:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
Sep/4/20
20Transcription Error
Sep-04-2020
12:03:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
OpenedResponse to "Date of
Completion/Discontinuation
/Death" 04/Oct/2020 is a
future date relative to when
it was entered on 04/Sep
/2020. Please correct.
Sep-04-2020
12:03:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
Oct/4/20
20Initial Entry
2. Phase of Disposition:
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904217
Page 100 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-04-2020
12:03:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020
12:03:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904218
Page 101 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020
12:03:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:hyperten
sion
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:03:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:03:33
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904219
Page 102 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-04-2020
12:03:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020
12:03:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-04-2020
12:05:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical Hi
story Term
:HYPERL
IPIDEMI
A
Start Date: UNK/UN
K/2015
Ongoing: YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904220
Page 103 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:05:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:05:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPERLIPIDEMIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020
12:05:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020
12:05:19ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904221
Page 104 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-04-2020
12:05:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:ARTHRI
TIS
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904222
Page 105 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:05:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:05:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ARTHRITISInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020
12:05:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020
12:05:45ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904223
Page 106 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Sep-04-2020
12:06:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:HYPOKA
LEMIA
Start Date
:Feb/UNK/
2020
Ongoing: NO
End Dat
e:
Feb/U
NK/20
20Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904224
Page 107 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:06:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:06:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYPOKALEMIAInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-04-2020
12:06:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-04-2020
12:06:24ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904225
Page 108 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Feb/UNK/2020
1.e
Date Location User Value Reason
Sep-04-2020
12:06:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:5
Medical
History
Term:ARTERIAL
THROMBO
SIS
Start Da
te:Feb/UNK/2
020
Ongoing
:NO
End Date:
Feb/UN
K/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904226
Page 109 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:06:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:06:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ARTERIAL THRO
MBOSISInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-04-2020
12:06:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-04-2020
12:06:57ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904227
Page 110 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Feb/UNK/2020
1.f
Date Location User Value Reason
Sep-04-2020
12:07:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:6
Medica
l Histor
y Term:LEFT TOTA
L HIP REPL
ACEMENT
Start D
ate:Jan/UNK/201
9
Ongoin
g:NO
End Date:
Jan/UNK/
2019Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904228
Page 111 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:07:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:07:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFT TOTAL HIP
REPLACEMENTInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-04-2020
12:07:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-04-2020
12:07:43ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904229
Page 112 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Jan/UNK/2019
1.g
Date Location User Value Reason
Sep-04-2020
12:08:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:UTERINE
FIBROIDS
Start Dat
e:UNK/UNK
/1980
Ongoing: NO
End Date:
UNK/U
NK/198
0Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904230
Page 113 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:08:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:08:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UTERINE FIBROI
DSInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-04-2020
12:08:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-04-2020
12:08:23ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904231
Page 114 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/1980
1.h
Date Location User Value Reason
Sep-04-2020
12:09:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:HYSTERE
CTOMY
Start Date
:UNK/UN
K/1980
Ongoing: NO
End Date
:
UNK/U
NK/198
0Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904232
Page 115 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:09:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:09:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMYInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-04-2020
12:09:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-04-2020
12:09:03ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904233
Page 116 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/1980
1.i
Date Location User Value Reason
Sep-04-2020
12:09:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:9
Medical
History
Term:CONGESTI
VE HEART
FAILURE
Start Da
te:Feb/UNK/2
020
Ongoing
:YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904234
Page 117 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-04-2020
12:09:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020
12:09:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CONGESTIVE HE
ART FAILUREInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-04-2020
12:09:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-04-2020
12:09:36ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904235
Page 118 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904236
Page 119 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
69.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904237
Page 120 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
170.2Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.0Initial Entry
7.a
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:37.0Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904238
Page 121 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904239
Page 122 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
12:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904240
Page 123 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904241
Page 124 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie
r:Not
Don
e
Test:: Not
Don
e
Result:: Not
Don
e
Not Done:: Not
Don
eInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904242
Page 125 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020
12:10:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-04-2020
12:10:30ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904243
Page 126 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904244
Page 127 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020
12:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020
12:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
251380Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904245
Page 128 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
15:40:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
15:40:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
15:40:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Sep-04-2020
15:40:26
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ate'Sample
Collected?' is
Yes, however
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904246
Page 129 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
15:40:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collect
ion:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
15:40:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BLBB
TZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
15:40:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLBBTZInitial Entry
5.b
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904247
Page 130 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-04-2020
15:40:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BLBB
V0Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020
15:40:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLBBV0Initial Entry
5.c
Date Location User Value Reason
Sep-04-2020
15:41:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN5S
G3Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904248
Page 131 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-04-2020
15:41:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SG3Initial Entry
5.d
Date Location User Value Reason
Sep-04-2020
15:41:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN5S
G4Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-04-2020
15:41:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SG4Initial Entry
5.e
Date Location User Value Reason
Sep-04-2020
15:41:34ACV0PFEINFP6000  Data Entry:
Sample I BN5SInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904249
Page 132 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time
(US & Canada)D: G5
5.e Sample ID
Date Location User Value Reason
Sep-04-2020
15:41:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SG5Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904250
Page 133 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
15:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
15:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
15:42:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Sep-04-2020
15:41:54
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ate'Sample
Collected?' is
Yes, however
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904251
Page 134 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
15:41:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collect
ion:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
15:42:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BN5S
M4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
15:42:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BN5SM4Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904252
Page 135 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904253
Page 136 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 12:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904254
Page 137 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-04-2020
12:16:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904255
Page 138 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020
12:16:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904256
Page 139 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020
13:58:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904257
Page 140 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
16:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020
16:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.6
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
16:40:57
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904258
Page 141 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-23-2020
16:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020
16:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020
16:40:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904259
Page 142 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904260
Page 143 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie
r:Not
Don
e
Test:: Not
Don
e
Result:: Not
Don
e
Not Done:: Not
Don
eInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904261
Page 144 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Sep-23-2020
16:41:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-23-2020
16:41:22ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904262
Page 145 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904263
Page 146 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020
09:04:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020
09:04:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020
09:04:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Sep-24-2020
09:04:35
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ate'Sample
Collected?' is
Yes, however
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904264
Page 147 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-24-2020
09:04:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collect
ion:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
09:04:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BM8S
CCInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
09:04:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM8SCCInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904265
Page 148 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904266
Page 149 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 10:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904267
Page 150 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-23-2020
13:58:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904268
Page 151 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
10:35:23
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed resolved
Oct-26-2020
14:48:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answer
edvisit 3 data
has been
uploaded
into
Florence
Oct-26-2020
14:26:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened No source
for this visit
in Florence.
Please
upload as
soon as
possible.
Oct-21-2020
13:06:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904269
Page 152 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
13:07:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
13:07:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
13:07:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Oct-21-2020
13:07:03
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ate'Sample
Collected?' is
Yes, however
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904270
Page 153 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-21-2020
13:07:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collect
ion:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
13:07:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BS6L
ZFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
13:07:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS6LZFInitial Entry
5.b
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904271
Page 154 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-21-2020
13:07:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample
ID:BLBB
D7Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
13:07:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLBBD7Initial Entry
5.c
Date Location User Value Reason
Oct-21-2020
13:07:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BKP2
64Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904272
Page 155 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
13:07:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BKP264Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904273
Page 156 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020
15:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020
15:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020
15:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904274
Page 157 of 162
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021
17:38:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904275
Page 158 of 162
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021
17:39:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904276
Page 159 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-23-2021
17:38:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-23-2021
17:38:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904277
Page 160 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-21-2020
15:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020
12:15:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-04-2020
12:03:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-21-2020
15:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Sep-04-2020
12:15:30ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904278
Page 161 of 162
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Sep-04-2020
12:03:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Transcription
Error
Sep-04-2020
12:03:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/4/2020Initial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904279
Page 162 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
10:43:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae3d47\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904280