Document text
Page 1 of 251
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824285
Page 2 of 251
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/3/2020
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824286
Page 3 of 251
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12181051]
2.Birth Date: 1973
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824287
Page 4 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824288
Page 5 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824289
Page 6 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathDec/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824290
Page 7 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[drug allergy: penicillin]
Start Date: Apr/18/2002
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[non-drug allergy: bee stings]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[surgery: hysterectomy]
Start Date: Jan/UNK/2018
Ongoing: NO
End Date:
Jan/UNK/2018
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bladder mesh insertion]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824291
Page 8 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Disease: Migraines]
Start Date: UNK/UNK/1999
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Disease: high blood pressure]
Start Date: UNK/UNK/2002
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Disease: high cholesterol]
Start Date: UNK/UNK/2019
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[heart murmur]
Start Date: UNK/UNK/2019
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824292
Page 9 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[difficulty breathing/wheezing-intermittent]
Start Date: UNK/UNK/2020
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthritis]
Start Date: UNK/UNK/2015
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic bilateral knee pain]
Start Date: Dec/UNK/2015
Ongoing: YES
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824293
Page 10 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/3/2020
2.Weight: [125.1]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [43.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824294
Page 11 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824295
Page 12 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/3/2020
2.Randomization Number: [117431]
3.Randomization Group: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824296
Page 13 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
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 [BR8NVT]
5.bSample ID [BS72CM]
5.cSample ID [BS72CP]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824297
Page 14 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
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 [BR8NVS]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824298
Page 15 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Dec/3/2020 16:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824299
Page 16 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824300
Page 17 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824301
Page 18 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824302
Page 19 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/23/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824303
Page 20 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NY7]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824304
Page 21 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Dec/23/2020 10:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824305
Page 22 of 251
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824306
Page 23 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BS72HN]
5.bSample ID [BS72HM]
5.cSample ID [BR8NJM]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824307
Page 24 of 251
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824308
Page 25 of 251
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824309
Page 26 of 251
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824310
Page 27 of 251
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824311
Page 28 of 251
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824312
Page 29 of 251
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824313
Page 30 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824314
Page 31 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/12/2021
2.Date of First Symptom Started: Jan/9/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/29/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824315
Page 32 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [nasal congestion]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824316
Page 33 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/10/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824317
Page 34 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/10/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT DIAGNOSTICS ID NOW COVID-19
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824318
Page 35 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[site collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824319
Page 36 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
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 [BR8P00]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824320
Page 37 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824321
Page 38 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824322
Page 39 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824323
Page 40 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824324
Page 41 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824325
Page 42 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824326
Page 43 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for La
b TestVendor N
ameCollection
Date:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824327
Page 44 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824328
Page 45 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824329
Page 46 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824330
Page 47 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Jan/12/2021 Record Identifier: Systolic: Diastolic:
1 122 76 Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824331
Page 48 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/12/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [122]
Diastolic: [76]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [69]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824332
Page 49 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Jan/12/2021 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824333
Page 50 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/12/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824334
Page 51 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824335
Page 52 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824336
Page 53 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824337
Page 54 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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.Start Date: //
6.Ongoing?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824338
Page 55 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824339
Page 56 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824340
Page 57 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824341
Page 58 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/24/2021
2.Date of First Symptom Started: Feb/23/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824342
Page 59 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824343
Page 60 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824344
Page 61 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824345
Page 62 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[site collected swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824346
Page 63 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
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 [BR8NLF]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824347
Page 64 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824348
Page 65 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824349
Page 66 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824350
Page 67 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824351
Page 68 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824352
Page 69 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824353
Page 70 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for La
b TestVendor N
ameCollection
Date:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824354
Page 71 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824355
Page 72 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824356
Page 73 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824357
Page 74 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Feb/24/2021 Record Identifier: Systolic: Diastolic:
1 122 82 Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824358
Page 75 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/24/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [122]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[21]
Heart Rate in beats/minute: [61]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824359
Page 76 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Feb/24/2021 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824360
Page 77 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/24/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824361
Page 78 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824362
Page 79 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824363
Page 80 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824364
Page 81 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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.Start Date: //
6.Ongoing?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824365
Page 82 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824366
Page 83 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824367
Page 84 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/17/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824368
Page 85 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
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 [BR8NLC]
5.bSample ID [BS72KD]
5.cSample ID [BS72KC]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824369
Page 86 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824370
Page 87 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824371
Page 88 of 251
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Asthma exacerb
ation Jan/16/2021 UNK:
UNK NO
End Date Time:
Jan/18/2021 UNK:UNK
Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824372
Page 89 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Asthma exacerbation]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/18/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824373
Page 90 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
[Asthma]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021047330]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824374
Page 91 of 251
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication E
rrorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824375
Page 92 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824376
Page 93 of 251
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Medicati
onStart D
ateForm Instanc
e
1.1 VACCINATION
S NO Hepatitis B Adjuva
nt Vaccine Jan/17/2
021 Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824377
Page 94 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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).[Hepatitis B Adjuvant Vaccine]
5.Date: Jan/17/2021
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824378
Page 95 of 251
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824379
Page 96 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824380
Page 97 of 251
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824381
Page 98 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824382
Page 99 of 251
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824383
Page 100 of 251
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824384
Page 101 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824385
Page 102 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824386
Page 103 of 251
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824387
Page 104 of 251
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824388
Page 105 of 251
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824389
Page 106 of 251
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824390
Page 107 of 251
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824391
Page 108 of 251
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824392
Page 109 of 251
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824393
Page 110 of 251
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824394
Page 111 of 251
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824395
Page 112 of 251
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824396
Page 113 of 251
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Jan/21/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824397
Page 114 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824398
Page 115 of 251
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824399
Page 116 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824400
Page 117 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/23/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824401
Page 118 of 251
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824402
Page 119 of 251
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824403
Page 120 of 251
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/21/2021
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824404
Page 121 of 251
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824405
Page 122 of 251
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-10-2021 15:33:04 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824406
Page 123 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-03-2020 16:29:01 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824407
Page 124 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824408
Page 125 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824409
Page 126 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824410
Page 127 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824411
Page 128 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824412
Page 129 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824413
Page 130 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824414
Page 131 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824415
Page 132 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824416
Page 133 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Feb-24-2021 13:32:47 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824417
Page 134 of 251
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-10-2021 15:33:04 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-11-2021 11:47:41 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-29-2021 20:59:34 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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 Jan-29-2021 11:16:19 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824418
Page 135 of 251
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Laura Hammit Approved Jan-26-2021 23:05:46 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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 Jan-25-2021 14:57:54 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-23-2021 07:35:49 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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 Jan-12-2021 15:40:32 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-11-2021 13:37:43 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824419
Page 136 of 251
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, LauraHammit, 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-23-2020 10:12:10 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Dec-04-2020 22:39:42 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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.
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824420
Page 137 of 251
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Dec-03-2020 16:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Dec-03-2020 16:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824421
Page 138 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-03-2020 16:27:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/3/2020Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824422
Page 139 of 251
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-03-2020 16:26:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12181051Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Dec-03-2020 16:26:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-03-2020 16:28:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-03-2020 16:28:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-03-2020 16:28:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AMERICAN INDIAN OR ALA
SKA NATIVEInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824423
Page 140 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-07-2020 01:58:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-04-2020 12:37:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered completed
Dec-04-2020 05:18:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete ‘Medical
History and Vital
Signs' at this visit.
Thank you.
Dec-03-2020 16:28:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824424
Page 141 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Dec-03-2020 16:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-03-2020 16:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-03-2020 16:39:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824425
Page 142 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Dec-04-2020 11:20:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:drug allergy: pe
nicillin
Start Date: Apr/18/2002
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:20:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:20:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
drug allergy: penicillinInitial Entry
1.a Start Date:
Date Location User Value Reason
Dec-04-2020 11:20:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/18/2002Initial Entry
1.a Ongoing:
Date Location User Value Reason
Dec-04-2020 11:20:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824426
Page 143 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b
Date Location User Value Reason
Dec-04-2020 11:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:non-drug allergy:
bee stings
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
non-drug allergy: bee stingsInitial Entry
1.b Start Date:
Date Location User Value Reason
Dec-04-2020 11:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Dec-04-2020 11:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824427
Page 144 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-04-2020 11:33:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:surgery: hyster
ectomy
Start Date: Jan/UNK/2018
Ongoing: NO
End Date:
Jan/UNK/2
018Transcription Error
Dec-04-2020 11:32:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:surgery: hyster
ectomy
Start Date: Jan/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/
2018Transcription Error
Dec-04-2020 11:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:surgery: hyster
ectomy
Start Date: UNK/UNK/20
18
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824428
Page 145 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
surgery: hysterectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-04-2020 11:32:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2018Transcription Error
Dec-04-2020 11:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Dec-04-2020 11:33:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/UNK/2018Transcription Error
Dec-04-2020 11:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.d
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824429
Page 146 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-04-2020 11:32:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:bladder mesh in
sertion
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:32:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:32:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
bladder mesh insertionInitial Entry
1.d Start Date:
Date Location User Value Reason
Dec-04-2020 11:32:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Dec-04-2020 11:32:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824430
Page 147 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.e
Date Location User Value Reason
Dec-04-2020 11:34:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Disease: Migr
aines
Start Date: UNK/UNK/1
999
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:34:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:34:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Disease: MigrainesInitial Entry
1.e Start Date:
Date Location User Value Reason
Dec-04-2020 11:34:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.e Ongoing:
Date Location User Value Reason
Dec-04-2020 11:34:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824431
Page 148 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-04-2020 11:55:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:Disease: high blo
od pressure
Start Date: UNK/UNK/2002
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:55:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:55:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Disease: high blood pressureInitial Entry
1.f Start Date:
Date Location User Value Reason
Dec-04-2020 11:55:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.f Ongoing:
Date Location User Value Reason
Dec-04-2020 11:55:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824432
Page 149 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-04-2020 11:56:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Disease: high ch
olesterol
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:56:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:56:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Disease: high cholesterolInitial Entry
1.g Start Date:
Date Location User Value Reason
Dec-04-2020 11:56:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Dec-04-2020 11:56:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Dec-04-2020 11:57:34 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824433
Page 150 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain
Time (US & Canada)(autocalc) Line/MH Numbe
r:8
Medical History
Term:heart murmu
r
Start Date: UNK/UNK/2
019
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:57:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:57:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
heart murmurInitial Entry
1.h Start Date:
Date Location User Value Reason
Dec-04-2020 11:57:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Dec-04-2020 11:57:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Dec-04-2020 11:58:13
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 9Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824434
Page 151 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) r:
Medical History
Term:asthma
Start Date: UNK/UNK/1
990
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Dec-04-2020 11:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 11:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
asthmaInitial Entry
1.i Start Date:
Date Location User Value Reason
Dec-04-2020 11:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.i Ongoing:
Date Location User Value Reason
Dec-04-2020 11:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Dec-04-2020 12:29:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:10Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824435
Page 152 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Medical Hi
story Term
:difficulty breathing/
wheezing-intermitte
nt
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824436
Page 153 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Dec-04-2020 12:29:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 12:29:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
difficulty breathing/wheezing-int
ermittentInitial Entry
1.j Start Date:
Date Location User Value Reason
Dec-08-2020 02:13:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed per response
'This is related to
asthma issues and
had been going
before any vaccine
administration.'
Dec-07-2020 08:01:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This is related to
asthma issues and
had been going
before any vaccine
administration. Per
participant, they
have not had this
problem "in quite
awhile" but did
happen in 2020.
Should this not be
reported separately
asthma? Thank you.
Dec-07-2020 00:46:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please confirm if
event has been
ongoing since
before? or after first
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824437
Page 154 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
vaccination date
03Dec2020?
Dec-04-2020 12:32:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered she has not had an
issue in awhile but
could not give a
date. this occurs
when she has an
asthma
exacerbation but
hasn't for several
months
Dec-04-2020 12:29:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
03/Dec/2020.
Please review and
update as
appropriate.
Dec-04-2020 12:29:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.j Ongoing:
Date Location User Value Reason
Dec-04-2020 12:29:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Dec-04-2020 12:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:anemia
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824438
Page 155 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.k Line/MH Number:
Date Location User Value Reason
Dec-04-2020 12:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 12:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
anemiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Dec-04-2020 12:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.k Ongoing:
Date Location User Value Reason
Dec-04-2020 12:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Dec-04-2020 12:34:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History T
erm:arthritis
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824439
Page 156 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.l Line/MH Number:
Date Location User Value Reason
Dec-04-2020 12:34:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 12:34:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
arthritisInitial Entry
1.l Start Date:
Date Location User Value Reason
Dec-04-2020 12:34:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.l Ongoing:
Date Location User Value Reason
Dec-04-2020 12:34:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Dec-04-2020 12:34:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histo
ry Term:chronic bilateral
knee pain
Start Date: Dec/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824440
Page 157 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.m Line/MH Number:
Date Location User Value Reason
Dec-04-2020 12:34:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-04-2020 12:34:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chronic bilateral knee painInitial Entry
1.m Start Date:
Date Location User Value Reason
Dec-04-2020 12:34:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2015Initial Entry
1.m Ongoing:
Date Location User Value Reason
Dec-04-2020 12:34:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824441
Page 158 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
125.1Initial Entry
3. Unit:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824442
Page 159 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
43.8Initial Entry
7.a
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Dec-04-2020 12:37:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824443
Page 160 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824444
Page 161 of 251
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-03-2020 17:05:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824445
Page 162 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-03-2020 17:05:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-03-2020 17:05:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
117431Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824446
Page 163 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 17:07:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 17:07:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020 17:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 17:07:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-03-2020 17:07:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-03-2020 17:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NVTInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824447
Page 164 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-03-2020 17:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NVTInitial Entry
5.b
Date Location User Value Reason
Dec-03-2020 17:07:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72CMInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-03-2020 17:07:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72CMInitial Entry
5.c
Date Location User Value Reason
Dec-03-2020 17:08:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72CPInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-03-2020 17:08:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72CPInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824448
Page 165 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-03-2020 17:06:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-03-2020 17:06:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-03-2020 17:06:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-03-2020 17:06:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-03-2020 17:06:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
Dec-03-2020 17:06:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NVSInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824449
Page 166 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-03-2020 17:06:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NVSInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824450
Page 167 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020 16:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824451
Page 168 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-03-2020 17:06:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824452
Page 169 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Dec-03-2020 17:05:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824453
Page 170 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-29-2020 03:31:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed data
has been updated
Dec-28-2020 19:47:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Done
Dec-28-2020 03:06:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete
‘Vaccination form'
at this visit. Thank
you.
Dec-23-2020 10:12:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824454
Page 171 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-23-2020 10:12:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
2.a
Date Location User Value Reason
Dec-23-2020 10:12:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.5
Temperature Unit
:F
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-23-2020 10:12:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-23-2020 10:12:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-23-2020 10:12:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824455
Page 172 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.a Temperature Location:
Date Location User Value Reason
Dec-23-2020 10:12:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824456
Page 173 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824457
Page 174 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Dec-23-2020 10:12:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824458
Page 175 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 11:46:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 11:46:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-23-2020 11:46:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-23-2020 11:46:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 11:46:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
5.a
Date Location User Value Reason
Dec-23-2020 11:46:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NY7Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824459
Page 176 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-23-2020 11:46:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NY7Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824460
Page 177 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-28-2020 19:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 10:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824461
Page 178 of 251
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-28-2020 19:46:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824462
Page 179 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021 11:52:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824463
Page 180 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-11-2021 11:52:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-11-2021 11:52:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-11-2021 11:54:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-11-2021 11:52:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-11-2021 11:52:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
5.a
Date Location User Value Reason
Feb-11-2021 11:54:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72HNInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824464
Page 181 of 251
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Feb-11-2021 11:54:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72HNInitial Entry
5.b
Date Location User Value Reason
Feb-11-2021 11:54:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72HMInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-11-2021 11:54:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72HMInitial Entry
5.c
Date Location User Value Reason
Feb-11-2021 11:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NJMInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-11-2021 11:59:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NJMInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824465
Page 182 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021 01:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-17-2021 12:18:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered completed today
Feb-17-2021 02:26:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened PDQ: Convalescent
visit is missing and
35 days (36) have
passed since
COVID Illness
Visit. If visit
occurred record
data as a matching
CONVA visit; if
visit did not occur
attempt to schedule
visit even if OOW
and obtain the
CONVA sample
else clarify.
Jan-12-2021 15:43:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-12-2021 15:40:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824466
Page 183 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
as appropriate.
Jan-12-2021 15:40:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Jan-12-2021 15:40:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-12-2021 15:40:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0824467
Page 184 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/9/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-02-2021 22:28:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-02-2021 16:37:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Mar-02-2021 16:37:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resol
ved:
Jan/29/2021New Information
Feb-24-2021 21:59:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Next visit
should be entered
only if all the
symptoms at this
visit resolved. If
resolved, please
review and update
the date of last
symptom resolved
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824468
Page 185 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
as appropriate. If
not, please move
details from next
visit into this visit.
Thank you.
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824469
Page 186 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.b Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824470
Page 187 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824471
Page 188 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.e Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824472
Page 189 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824473
Page 190 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.h Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Present
:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-12-2021 15:41:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824474
Page 191 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021 15:41:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Oth
er:nasal congesti
onInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-12-2021 15:41:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
nasal congestionInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824475
Page 192 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824476
Page 193 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/10/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824477
Page 194 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ABBOTT DIAGNOSTICS ID N
OW COVID-19Initial Entry
7. Test Result:
Date Location User Value Reason
Jan-12-2021 15:42:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824478
Page 195 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 15:43:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 15:43:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021 15:43:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-12-2021 15:43:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
site collectedInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824479
Page 196 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 15:43:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 15:43:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021 15:43:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 15:43:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-12-2021 15:43:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/12/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021 15:43:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8P00Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824480
Page 197 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-12-2021 15:43:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8P00Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824481
Page 198 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824482
Page 199 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824483
Page 200 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824484
Page 201 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIO
NInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824485
Page 202 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-12-2021 15:44:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824486
Page 203 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-12-2021 15:44:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNE
SSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-12-2021 15:45:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-12-2021 15:45:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Jan-12-2021 15:44:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Yes is selected,
however, either the
diagnosis details or
date of diagnosis is
missing. Please
correct.
Jan-12-2021 15:44:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Diagnosis:
Jan/10/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-12-2021 15:44:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824487
Page 204 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 10-Oct-2020 15:59 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824488
Page 205 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
2.a
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Systolic:: 12
2
Diastolic:: 76
Respiratory Rate in respir
ations/minute:16
Heart Rate in beats/minute
:69Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Systolic:
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
122Initial Entry
2.a Diastolic:
Date Location User Value Reason
Jan-12-2021 15:46:41 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824489
Page 206 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain
Time (US & Canada)76
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Jan-12-2021 15:46:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824490
Page 207 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Audit Trail
Form Version: 10-Oct-2020 16:04 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-12-2021 15:46:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824491
Page 208 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/12/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Jan-12-2021 15:47:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
2.a
Date Location User Value Reason
Jan-12-2021 15:46:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Oxygen Saturation: 97.0Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-12-2021 15:46:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a SPO2 Pulse Oximetry %
Date Location User Value Reason
Jan-12-2021 15:46:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.0Initial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824492
Page 209 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 15:54:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-24-2021 13:30:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-24-2021 13:30:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Feb-24-2021 13:30:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-24-2021 13:30:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824493
Page 210 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/24/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824494
Page 211 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Prese
nt:YESInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824495
Page 212 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.c Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
Sympto NEW OR INCREAInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824496
Page 213 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) ms: SED MUSCLE PA
IN
Sympto
m Presen
t:YES
4.e Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824497
Page 214 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.f Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Prese
nt:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (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-2021-5683-0824498
Page 215 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
090177e196ae3e9a\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824499
Page 216 of 251
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.i Symptoms:
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-24-2021 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOIni
…[truncated]