Document text
Page 1 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945655
Page 2 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945656
Page 3 of 241
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11771317]
2.Birth Date: /1958
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): ASIAN
6.Racial Designation: JAPANESE
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945657
Page 4 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945658
Page 5 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945659
Page 6 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945660
Page 7 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to latex]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to bee venom]
Start Date: UNK/UNK/1970
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to tomatoes]
Start Date: UNK/UNK/1970
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945661
Page 8 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Transient ischemic attack ("mini stroke")]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes, Type II]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipidemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945662
Page 9 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/1990
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Barrett's esophagus]
Start Date: UNK/UNK/2010
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: UNK/UNK/1990
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945663
Page 10 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Septoplasty]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Deviated septum]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Removal of vocal cord polyp]
Start Date: UNK/UNK/1997
Ongoing: NO
End Date:
UNK/UNK/1997
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945664
Page 11 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vocal cord polyp]
Start Date: UNK/UNK/1997
Ongoing: NO
End Date:
UNK/UNK/1997
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal tunnel syndrome, bilateral]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal tunnel release, bilateral]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945665
Page 12 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Broken wrist, left]
Start Date: Jul/27/2020
Ongoing: NO
End Date:
Jul/27/2020
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Broken wrist repair, left]
Start Date: Jul/27/2020
Ongoing: NO
End Date:
Jul/27/2020
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945666
Page 13 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [79.4]
3.Unit: kg
4.Height: [158.5]
5.Unit: cm
6.Body Mass Index: [31.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945667
Page 14 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945668
Page 15 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [255088]
3.Randomization Group: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945669
Page 16 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP0TFX]
5.bSample ID [BLCGFX]
5.cSample ID [BLCGFY]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945670
Page 17 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP8J8N]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945671
Page 18 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/9/2020 08:48
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
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945672
Page 19 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945673
Page 20 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945674
Page 21 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945675
Page 22 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945676
Page 23 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BR92VG]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945677
Page 24 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/30/2020 08:12
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
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945678
Page 25 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945679
Page 26 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
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 [BRJ5CJ]
5.bSample ID [BSMJ5M]
5.cSample ID [BSMJ5N]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945680
Page 27 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945681
Page 28 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945682
Page 29 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945683
Page 30 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945684
Page 31 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945685
Page 32 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945686
Page 33 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945687
Page 34 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945688
Page 35 of 241
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945689
Page 36 of 241
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945690
Page 37 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945691
Page 38 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945692
Page 39 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945693
Page 40 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945694
Page 41 of 241
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Breast Cancer,
Stage 1 Nov/30/2020
14:00 YES Repeating
Pages
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945695
Page 42 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Breast Cancer, Stage 1]
4.Start Date Time: Nov/30/2020 14:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945696
Page 43 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Neoplasia]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020511355]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945697
Page 44 of 241
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945698
Page 45 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945699
Page 46 of 241
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart D
ateForm Instan
ce
1.1 VACCINATIO
NS NO Flu vaccine Oct/15/
2020 Repeating
Pages
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945700
Page 47 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Flu vaccine]
5.Date: Oct/15/2020
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945701
Page 48 of 241
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945702
Page 49 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945703
Page 50 of 241
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945704
Page 51 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945705
Page 52 of 241
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945706
Page 53 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945707
Page 54 of 241
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945708
Page 55 of 241
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945709
Page 56 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945710
Page 57 of 241
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945711
Page 58 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945712
Page 59 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945713
Page 60 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945714
Page 61 of 241
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945715
Page 62 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945716
Page 63 of 241
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945717
Page 64 of 241
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945718
Page 65 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945719
Page 66 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945720
Page 67 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945721
Page 68 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945722
Page 69 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945723
Page 70 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8VJK]
5.bSample ID [BSH97C]
5.cSample ID [BSH97D]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945724
Page 71 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR92C9]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945725
Page 72 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 07:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945726
Page 73 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945727
Page 74 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945728
Page 75 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR92JH]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945729
Page 76 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 07:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945730
Page 77 of 241
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945731
Page 78 of 241
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945732
Page 79 of 241
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945733
Page 80 of 241
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945734
Page 81 of 241
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945735
Page 82 of 241
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945736
Page 83 of 241
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945737
Page 84 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945738
Page 85 of 241
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945739
Page 86 of 241
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
David
Fitz-Patrick Approved Mar-08-2021 16:40:35 (UTC-10:00)
Aleutian IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, 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.
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945740
Page 87 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-09-2020 12:23:29 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945741
Page 88 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945742
Page 89 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945743
Page 90 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945744
Page 91 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945745
Page 92 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945746
Page 93 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945747
Page 94 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945748
Page 95 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945749
Page 96 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-09-2020 12:24:55 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945750
Page 97 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945751
Page 98 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945752
Page 99 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945753
Page 100 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945754
Page 101 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945755
Page 102 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945756
Page 103 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945757
Page 104 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945758
Page 105 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-30-2020 09:34:46 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945759
Page 106 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-18-2021 08:01:34 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945760
Page 107 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945761
Page 108 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Jan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945762
Page 109 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Jan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945763
Page 110 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Jan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945764
Page 111 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Jan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945765
Page 112 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Jan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945766
Page 113 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aJan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945767
Page 114 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aJan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945768
Page 115 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aJan-18-2021 08:02:06 (UTC-10:00)
Aleutian IslandsNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945769
Page 116 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945770
Page 117 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945771
Page 118 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945772
Page 119 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945773
Page 120 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945774
Page 121 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945775
Page 122 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945776
Page 123 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945777
Page 124 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-08-2021 07:27:16 (UTC-10:00)
Aleutian IslandsSarah
ThompsonNot Applicable
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945778
Page 125 of 241
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
David
Fitz-Patrick Approved Mar-08-2021 16:40:35 (UTC-10:00)
Aleutian IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, 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.
Sarah
Thompson N/A Feb-08-2021 07:27:08 (UTC-10:00)
Aleutian IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Jan-20-2021 11:38:00 (UTC-10:00)
Aleutian IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, 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.
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945779
Page 126 of 241
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
N/A Dec-28-2020 10:29:31 (UTC-10:00)
Aleutian IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Dec-10-2020 15:11:43 (UTC-10:00)
Aleutian IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-10-2020 13:40:22 (UTC-10:00)
Aleutian IslandsEdit - All
signatures
invalidated
Affidavit:
N/A
David
Fitz-Patrick Approved Nov-03-2020 10:49:00 (UTC-10:00)
Aleutian IslandsBOOK Signed
Affidavit:
By my dated signature below, I, DavidFitz-Patrick, 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.
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945780
Page 127 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-09-2020 12:22:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020 12:22:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945781
Page 128 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020 12:22:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Sep/9/2020Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945782
Page 129 of 241
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020
12:22:35
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11771317Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020
12:22:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1958Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020 12:23:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-09-2020 12:23:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945783
Page 130 of 241
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-04-2020
10:58:40
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-04-2020
07:13:43
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Answered Japanese
Dec-03-2020
11:36:19
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Opened Subject is
indicated on
Demography
CRF as Asian,
please specify
further racial
designation as
Japanese (i.e.
defined as all
four
grandparents
born in Japan, of
Japanese
ancestry), or
Other
Sep-09-2020
12:23:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
ASIANInitial Entry
6. Racial Designation:
Date Location User Value Reason
Dec-10-2020
13:40:22
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
JAPANESEInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945784
Page 131 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 12:23:20
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945785
Page 132 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-09-2020 12:23:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020
12:23:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020 12:23:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945786
Page 133 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Sep-09-2020
16:36:24
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Allergic to
latex
Start Date: UNK/UN
K/1990
Ongoing: YESTranscription
Error
Sep-09-2020
16:35:24
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Allergic to l
atex
Start Date: UNK/UNK/
1990
Ongoing: NO
End Date:
UNK/UN
K/1990Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:35:24
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945787
Page 134 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:35:24
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Allergic to latexInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-09-2020 16:35:24
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-09-2020
16:36:24
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YESTranscription
Error
Sep-09-2020
16:35:24
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.b
Date Location User Value Reason
Sep-09-2020
16:36:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Allergic to b
ee venomInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945788
Page 135 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Start Date: UNK/UNK/
1970
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:36:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:36:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Allergic to bee venomInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-09-2020 16:36:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-09-2020 16:36:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945789
Page 136 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-09-2020
16:37:00
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Allergic to t
omatoes
Start Date: UNK/UNK/
1970
Ongoing: YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945790
Page 137 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:37:00
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:37:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Allergic to tomatoesInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-09-2020 16:37:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-09-2020 16:37:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-09-2020
16:38:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945791
Page 138 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical Histo
ry Term:Hypertensi
on
Start Date: UNK/UN
K/2018
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:38:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:38:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-09-2020 16:38:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-09-2020 16:38:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945792
Page 139 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e
Date Location User Value Reason
Sep-09-2020
16:39:57
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History
Term:Transient ischem
ic attack ("mini s
troke")
Start Dat
e:UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1
990Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945793
Page 140 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:39:57
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:39:57
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Transient ischemic attack ("
mini stroke")Initial Entry
1.e Start Date:
Date Location User Value Reason
Sep-09-2020 16:39:57
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-09-2020 16:39:57
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.f
Date Location User Value Reason
Sep-09-2020
16:40:41ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945794
Page 141 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsLine/MH Num
ber:6
Medical Histo
ry Term:Diabetes,
Type II
Start Date: UNK/UN
K/2010
Ongoing: YES
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945795
Page 142 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.f Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:40:41
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:40:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Diabetes, Type IIInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-09-2020 16:40:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-09-2020 16:40:41
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-09-2020
16:41:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945796
Page 143 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical Histo
ry Term:Dyslipide
mia
Start Date: UNK/UN
K/2019
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:41:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:41:09
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
DyslipidemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-09-2020 16:41:09
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-09-2020 16:41:09
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945797
Page 144 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.h
Date Location User Value Reason
Sep-09-2020
16:43:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histo
ry Term:Hypothyro
idism
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945798
Page 145 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.h Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:43:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:43:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-09-2020 16:43:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-09-2020 16:43:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-09-2020
16:43:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945799
Page 146 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical Histo
ry Term:Depressio
n
Start Date: UNK/UN
K/1990
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:43:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:43:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-09-2020 16:43:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-09-2020 16:43:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945800
Page 147 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.j
Date Location User Value Reason
Sep-09-2020
16:44:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:Barrett's es
ophagus
Start Date: UNK/UNK
/2010
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:44:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:44:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Barrett's esophagusInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945801
Page 148 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.j Start Date:
Date Location User Value Reason
Sep-09-2020
16:44:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-09-2020
16:44:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-09-2020
16:44:45
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:Sleep apne
a
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945802
Page 149 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.k Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:44:45
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:44:45
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sleep apneaInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-09-2020 16:44:45
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-09-2020 16:44:45
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-09-2020
16:45:23
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:12Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945803
Page 150 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical Hi
story Term
:Gastroesophag
eal reflux dise
ase
Start Date: UNK/UNK/20
10
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:45:23
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:45:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Gastroesophageal reflux dise
aseInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-09-2020 16:45:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-09-2020 16:45:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945804
Page 151 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.m
Date Location User Value Reason
Sep-09-2020
16:47:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:Septoplasty
Start Date: UNK/UNK/
1986
Ongoing: NO
End Date:
UNK/UN
K/1986Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945805
Page 152 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.m Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:47:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:47:06
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
SeptoplastyInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-09-2020 16:47:06
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1986Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-09-2020 16:47:06
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1986Initial Entry
1.n
Date Location User Value Reason
Sep-09-2020
16:48:15ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945806
Page 153 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsLine/MH Nu
mber:14
Medical Hist
ory Term:Deviated sep
tum
Start Date: UNK/UNK/
1986
Ongoing: NO
End Date:
UNK/UN
K/1986
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945807
Page 154 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.n Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:48:15
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:48:15
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Deviated septumInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-09-2020 16:48:15
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1986Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-09-2020 16:48:15
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1986Initial Entry
1.o
Date Location User Value Reason
Sep-09-2020
16:50:52ACV0PFEINFP6000 Data Entry: Transcription
Error
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945808
Page 155 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsLine/MH
Number:15
Medical H
istory Ter
m:Removal of vo
cal cord polyp
Start Date
:UNK/UNK/19
97
Ongoing: NO
End Date:
UNK/UNK
/1997
Sep-09-2020
16:49:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:15
Medical
History T
erm:Removal of vo
cal chord poly
ps
Start Date
:UNK/UNK/19
97
Ongoing: NO
End Date:
UNK/UNK/
1997Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0945809
Page 156 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.o Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:49:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020
16:50:52
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Removal of vocal cord poly
pTranscription
Error
Sep-09-2020
16:49:09
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Removal of vocal chord pol
ypsInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-09-2020 16:49:09
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-09-2020 16:49:09
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1997Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945810
Page 157 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.p
Date Location User Value Reason
Sep-09-2020
16:50:32
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:16
Medical Hist
ory Term:Vocal cord p
olyp
Start Date: UNK/UNK/
1997
Ongoing: NO
End Date:
UNK/UN
K/1997Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945811
Page 158 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.p Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:50:32
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:50:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Vocal cord polypInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-09-2020 16:50:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-09-2020 16:50:32
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1997Initial Entry
1.q
Date Location User Value Reason
Sep-10-2020
08:12:32ACV0PFEINFP6000 Data Entry: New Information
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945812
Page 159 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsLine/MH
Number:17
Medical
History T
erm:Carpal tunnel s
yndrome, bilate
ral
Start Dat
e:UNK/UNK/20
01
Ongoing: NO
End Date:
UNK/UNK/
2001
Sep-09-2020
16:51:46
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:17
Medical His
tory Term:Carpal tunnel
, bilateral
Start Date: UNK/UNK/2
001
Ongoing: NO
End Date:
UNK/UN
K/2001Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0945813
Page 160 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.q Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:51:46
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-10-2020
21:41:41
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Sep-10-2020
08:12:32
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dNew
Information
Sep-10-2020
08:12:32
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Data
Entry
:
Carpa
l tunn
el syn
drome
, bilat
eralNew
Information
Sep-10-2020
04:03:07
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify the
term
CARPAL
TUNNEL,
BILATERAL
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945814
Page 161 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
as follows.
The term
appears
incomplete,
please clarify
the condition
or procedure
being
reported. Are
you reporting
CARPAL
TUNNEL
SYNDROME
BILATERAL
? Or
CARPAL
TUNNEL
REPAIR
BILATERAL
? Or Other? if
so then edit
as such.
Otherwise
please clarify
the term
further.
Thank you.
Sep-09-2020
16:51:46
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Data
Entry
:
Carpa
l tunn
el, bil
ateralInitial Entry
1.q Start Date:
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945815
Page 162 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-09-2020 16:51:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-09-2020 16:51:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.r
Date Location User Value Reason
Sep-09-2020
16:53:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:18
Medical H
istory Ter
m:Carpal tunnel r
elease, bilateral
Start Date
:UNK/UNK/20
01
Ongoing: NO
End Date:
UNK/UNK/
2001Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945816
Page 163 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.r Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:53:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:53:28
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Carpal tunnel release, bilater
alInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-09-2020 16:53:28
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-09-2020 16:53:28
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.s
Date Location User Value Reason
Sep-09-2020
16:55:29ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945817
Page 164 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsLine/MH Nu
mber:19
Medical Histo
ry Term:Broken wri
st, left
Start Date: Jul/27/2020
Ongoing: NO
End Date:
Jul/27/2
020
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945818
Page 165 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.s Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:55:29
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:55:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Broken wrist, leftInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-09-2020 16:55:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Jul/27/2020Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-09-2020 16:55:29
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/27/2020Initial Entry
1.t
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945819
Page 166 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-09-2020
16:56:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:20
Medical His
tory Term:Broken wrist
repair, left
Start Date: Jul/27/2020
Ongoing: NO
End Date:
Jul/27/202
0Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945820
Page 167 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.t Line/MH Number:
Date Location User Value Reason
Sep-09-2020
16:56:42
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:56:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Broken wrist repair, leftInitial Entry
1.t Start Date:
Date Location User Value Reason
Sep-09-2020 16:56:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Jul/27/2020Initial Entry
1.t Ongoing:
Date Location User Value Reason
Sep-09-2020 16:56:42
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/27/2020Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945821
Page 168 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
79.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
158.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
cmInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945822
Page 169 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020
12:24:43
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.6Initial Entry
7.a
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 97.1
Temperature Un
it:F
Temperature Lo
cation::FOREH
EADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
97.1Initial Entry
7.a Unit:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945823
Page 170 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 12:24:43
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945824
Page 171 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) AleutianACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945825
Page 172 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
6.a
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sponsor-Defined
Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0945826
Page 173 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6.a Not Done:
Date Location User Value Reason
Sep-09-2020 12:24:55
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945827
Page 174 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020 12:25:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020 12:25:23
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
255088Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945828
Page 175 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 14:11:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 14:11:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
14:12:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
14:11:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-09-2020
14:11:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945829
Page 176 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep/9/2020
5.a
Date Location User Value Reason
Sep-09-2020 14:12:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BP0TFXInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 14:12:30
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BP0TFXInitial Entry
5.b
Date Location User Value Reason
Sep-09-2020 14:12:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BLCGFXInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-09-2020 14:12:47
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BLCGFXInitial Entry
5.c
Date Location User Value Reason
Sep-09-2020 14:12:59
(UTC-10:00) AleutianACV0PFEINFP6000 Data Entry:
Sample ID: BLCGFYInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945830
Page 177 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
5.c Sample ID
Date Location User Value Reason
Sep-09-2020 14:12:59
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BLCGFYInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0945831
Page 178 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
14:13:36
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
14:13:36
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 14:13:36
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 14:13:27
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BP8J8NInitial Entry
5.a Sample ID
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945832
Page 179 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-09-2020 14:13:27
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BP8J8NInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945833
Page 180 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 12:25:51
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020
12:25:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
12:25:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 12:25:51
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/9/2020 08:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945834
Page 181 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-09-2020
12:25:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 12:25:51
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
12:25:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020
12:25:51
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-09-2020 12:25:51
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945835
Page 182 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-09-2020 12:26:00
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECTE
D FOR THIS SUBJECTInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945836
Page 183 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 09:34:16
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945837
Page 184 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 09:34:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 09:34:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 97.3
Temperature Un
it:F
Temperature Lo
cation::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 09:34:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 09:34:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
97.3Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945838
Page 185 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.a Unit:
Date Location User Value Reason
Sep-30-2020 09:34:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 09:34:38
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945839
Page 186 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) AleutianACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945840
Page 187 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
6.a
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sponsor-Defined
Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0945841
Page 188 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6.a Not Done:
Date Location User Value Reason
Sep-30-2020 09:34:46
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945842
Page 189 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020
09:47:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020
09:47:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020
09:48:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-30-2020
09:47:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-30-2020
09:47:47ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945843
Page 190 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-10:00)
Aleutian IslandsDate of Collection:
Sep/30/2020
5.a
Date Location User Value Reason
Sep-30-2020 09:48:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BR92VGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 09:48:02
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BR92VGInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945844
Page 191 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020 09:35:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020
09:35:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020
09:35:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-30-2020 09:35:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sep/30/2020 08:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945845
Page 192 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-30-2020
09:35:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-30-2020 09:35:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-30-2020
09:35:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020
09:35:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-30-2020 09:35:21
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945846
Page 193 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 08:28:57
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945847
Page 194 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 09:46:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 09:46:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
09:46:50
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
09:46:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-28-2020
09:46:39
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945848
Page 195 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct/28/2020
5.a
Date Location User Value Reason
Oct-28-2020 09:46:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BRJ5CJInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 09:46:50
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BRJ5CJInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 09:47:01
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BSMJ5MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 09:47:01
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BSMJ5MInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 09:47:16
(UTC-10:00) AleutianACV0PFEINFP6000 Data Entry:
Sample ID: BSMJ5NInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945849
Page 196 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 09:47:16
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
BSMJ5NInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0945850
Page 197 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-28-2020 08:29:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 08:29:07
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 08:29:07
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945851
Page 198 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Dec-28-2020 10:29:31
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Form Created
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945852
Page 199 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021
11:42:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thanks
Jan-15-2021
15:41:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Answered Per CRA, we
should not leave
queries open for
a prolonged
period of time.
Jan-14-2021
13:26:34
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Open
edThanks for
confirming.
Please make
every effort
possible to
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945853
Page 200 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
obtain further
information and
respond to the
query once
additional
information is
available.
Jan-06-2021
16:44:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Answered Information is
unknown at this
time.
Information will
be provided once
site knows more
Jan-06-2021
13:53:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Clinical_ Per
report, the
subject was
diagnosed with
Breast Cancer.
However,
information on
clinical
presentation,
clinical setting
of diagnosis, and
workup
(including
imaging) are not
described.
Kindly provide
information in a
FU report.
Thank you.
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Breast Cancer, Stage 1Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945854
Page 201 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4. Start Date Time:
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Nov/30/2020 14:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-07-2021
09:28:49
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Jan-06-2021
17:00:02
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Answered AE was still
ongoing at last
contact
Jan-06-2021
12:19:45
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Query 1: Opened ClinQuery:
Please verify if
Breast Cancer,
Stage 1 is
ongoing, then
update the END
DATE and
OUTCOME as
appropriate
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945855
Page 202 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-01-2021
20:21:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Breast
Cancer, Stage 1:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YES
Is this serious event assoc
iated with congenital ano
maly or birth defect?
NO
Did this serious event resInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945856
Page 203 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importan
t serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945857
Page 204 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHER
If Other, specify:
NeoplasiaInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945858
Page 205 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-18-2021
21:24:04
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 2:
ClosedResponse satisfies query
Jan-18-2021
07:47:19
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredAnswer Auto Query
Jan-18-2021
07:47:19
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Data Ent
ry:
RECOVE
RING/RE
SOLVIN
GData updated and SAE follow up
report submitted
Jan-18-2021
02:20:52
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 2:
Reissued:
OpenedDM 1: Thank you for the response,
however the response to "What was
the outcome of this adverse event?"
is still 'Unknown' and "Is the
adverse event still ongoing?" is
marked "Yes", kindly review and
update the outcome of the AE.
Jan-07-2021
21:34:20
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 2:
Reissued:
CandidateQuery will be followed up regarding
the outcome of the AE
Jan-06-2021
16:44:01
(UTC-10:00)
AleutianACV0PFEINFP6000 Query 2:
AnsweredPer CRA, queries cannot remain
open for a prolonged period of time.
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945859
Page 206 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Islands
Jan-05-2021
22:23:31
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 2:
Reissued:
OpenedDM: Thank you for response. Please
review once data is available and
update response to "What was the
outcome of this adverse event?" on
this page as needed. Once CRF is
updated, respond to the query.
Jan-05-2021
03:28:41
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 1:
ClosedResponse satisfies query
Jan-04-2021
16:32:31
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 2:
AnsweredSite will follow up regarding the
outcome of the AE
Jan-04-2021
16:30:26
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 auto query
(autoquery)Query 2:
OpenedFor AE Breast Cancer, Stage 1:
Response to "What was the outcome
of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
the adverse event still ongoing?" is
marked "Yes".
Jan-04-2021
16:30:26
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription Error
Jan-04-2021
16:30:26
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Data Ent
ry:
UNKNO
WNTranscription Error
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945860
Page 207 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-01-2021
20:25:24
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Query 1:
OpenedSAE
RECON:AER#2020511355,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian
IslandsACV0PFEINFP6000 Data Ent
ry:
NOT RE
COVERE
D/NOT R
ESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-28-2020
10:29:31
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-01-2021 20:21:30
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
2020511355Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0945861
Page 208 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-28-2020 08:55:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Form Created
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945862
Page 209 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-28-2020 08:55:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-28-2020 08:55:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-28-2020 08:55:26
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Oct-28-2020 08:55:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Flu vaccineInitial Entry
5. Date:
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945863
Page 210 of 241
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-28-2020 08:55:26
(UTC-10:00) Aleutian
IslandsACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945864
Page 211 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021
17:40:52
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945865
Page 212 of 241
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-14-2021
17:41:03
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Participant is willing to re
turn for Vaccination 3
Participant is:
eligible per local/natio
nal recommendations
and confirmed to have
received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945866
Page 213 of 241
***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: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-14-2021
17:40:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-14-2021
17:40:44
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL VA
CCINATIONInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945867
Page 214 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021
08:01:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945868
Page 215 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-18-2021
08:01:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Ob
tained
Jan/18/2021Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945869
Page 216 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-18-2021
08:01:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-18-2021 08:01:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-18-2021
08:01:47
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945870
Page 217 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945871
Page 218 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Sponsor-Define
d Identifier:Not App
licable
Test:: Not App
licable
Result:: Not App
licable
Not Done:: Not App
licableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945872
Page 219 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6.a Result:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-18-2021
08:02:06
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945873
Page 220 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021 08:03:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021 08:03:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-18-2021
08:04:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-18-2021
08:03:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-18-2021
08:03:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945874
Page 221 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan/18/2021
5.a
Date Location User Value Reason
Jan-18-2021
08:04:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BR8VJKInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-18-2021
08:04:12
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
BR8VJKInitial Entry
5.b
Date Location User Value Reason
Jan-18-2021
08:04:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BSH97CInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-18-2021
08:04:21
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
BSH97CInitial Entry
5.c
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945875
Page 222 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Jan-18-2021
08:04:29
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BSH97DInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-18-2021
08:04:29
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
BSH97DInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945876
Page 223 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021 08:04:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021 08:04:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-18-2021
08:05:03
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-18-2021
08:04:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-18-2021
08:04:55
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945877
Page 224 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan/18/2021
5.a
Date Location User Value Reason
Jan-18-2021
08:05:03
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Sample ID: BR92C9Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-18-2021
08:05:03
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
BR92C9Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945878
Page 225 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-18-2021
08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-18-2021
08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
Jan/18/2021 07:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945879
Page 226 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-18-2021
08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945880
Page 227 of 241
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-18-2021 08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Jan-18-2021
08:02:28
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945881
Page 228 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021
07:27:08
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Feb/8/2021Initial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945882
Page 229 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945883
Page 230 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Sponsor-Defi
ned Identifier
:Not Ap
plicable
Test:: Not Ap
plicable
Result:: Not Ap
plicable
Not Done:: Not Ap
plicableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945884
Page 231 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6.a Result:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-08-2021
07:27:16
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 Sarah
ThompsonData Entry:
Not ApplicableInitial Entry
090177e196ae2fd9\Final\Final On: 01-Apr-2021 03:53 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945885
Page 232 of 241
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1177 Site Name: (1177) East-West Medical Research Institute
Subject No: 11771317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021
07:35:23
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021
07:35:23
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021
07:36:22
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-08-2021
07:35:23
(UTC-10:00)
Aleutian IslandsACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
…[truncated]