Document text
Page 1 of 143
***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: 12181046 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824142
Page 2 of 143
***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: 12181046 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/2/2020
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824143
Page 3 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12181046]
2.Birth Date: 1974
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:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824144
Page 4 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824145
Page 5 of 143
***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: 12181046 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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824146
Page 6 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathDec/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824147
Page 7 of 143
***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: 12181046 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: Sulfa]
Start Date: Feb/4/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rhinitis]
Start Date: Mar/1/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Surgery: Left Eye]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Surgery: Right Knee]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824148
Page 8 of 143
***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: 12181046 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:[Glaucoma]
Start Date: Apr/24/2014
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes]
Start Date: Jan/8/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: May/1/1992
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Detached Retina]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824149
Page 9 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824150
Page 10 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/2/2020
2.Weight: [119.9]
3.Unit: kg
4.Height: [175.5]
5.Unit: cm
6.Body Mass Index: [38.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824151
Page 11 of 143
***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: 12181046 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/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824152
Page 12 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/2/2020
2.Randomization Number: [117234]
3.Randomization Group: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824153
Page 13 of 143
***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: 12181046 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/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS72C9] Comments
5.bSample ID [BS72CB] Comments
5.cSample ID [BR8NVC] Comments
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824154
Page 14 of 143
***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: 12181046 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/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NV9]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824155
Page 15 of 143
***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: 12181046 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/2/2020 12:32
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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824156
Page 16 of 143
***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: 12181046 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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824157
Page 17 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824158
Page 18 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824159
Page 19 of 143
***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: 12181046 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/28/2020
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:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824160
Page 20 of 143
***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: 12181046 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/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NYJ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824161
Page 21 of 143
***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: 12181046 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/28/2020 10:51
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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824162
Page 22 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824163
Page 23 of 143
***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: 12181046 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/29/2021
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 [BR8NK5]
5.bSample ID [BS72JJ]
5.cSample ID [BS72JH]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824164
Page 24 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824165
Page 25 of 143
***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: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824166
Page 26 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824167
Page 27 of 143
***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: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824168
Page 28 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824169
Page 29 of 143
***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: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824170
Page 30 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824171
Page 31 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824172
Page 32 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824173
Page 33 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824174
Page 34 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824175
Page 35 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824176
Page 36 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824177
Page 37 of 143
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824178
Page 38 of 143
***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: 12181046 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:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824179
Page 39 of 143
***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: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824180
Page 40 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Acute Cholecystitis Dec/20/2020 01:0
0 NO
End Date Time:
Dec/22/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 Mature cystic teratoma
left ovary Dec/20/2020 UN
K:UNK NO
End Date Time:
Dec/22/2020 UNK:UN
K
Repeating
Pages
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824181
Page 41 of 143
***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: 12181046 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)[Acute Cholecystitis]
4.Start Date Time: Dec/20/2020 01:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/22/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824182
Page 42 of 143
***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: 12181046 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:
[Acute cholecystitis]
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[2020506377]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824183
Page 43 of 143
***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: 12181046 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mature cystic teratoma left ovary]
4.Start Date Time: Dec/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/22/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown-pelvic mass found incidentally on abdominal ultrasound]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824184
Page 44 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824185
Page 45 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824186
Page 46 of 143
***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: 12181046 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[ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824187
Page 47 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824188
Page 48 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 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.Date: //
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824189
Page 49 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824190
Page 50 of 143
***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: 12181046 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?
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824191
Page 51 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824192
Page 52 of 143
***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: 12181046 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?
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824193
Page 53 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824194
Page 54 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824195
Page 55 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824196
Page 56 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824197
Page 57 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824198
Page 58 of 143
***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: 12181046 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:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824199
Page 59 of 143
***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: 12181046 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:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824200
Page 60 of 143
***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: 12181046 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?
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824201
Page 61 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824202
Page 62 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824203
Page 63 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824204
Page 64 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824205
Page 65 of 143
***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: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824206
Page 66 of 143
***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: 12181046 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 [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824207
Page 67 of 143
***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: 12181046 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/29/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824208
Page 68 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824209
Page 69 of 143
***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: 12181046 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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824210
Page 70 of 143
***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: 12181046 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: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824211
Page 71 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/28/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824212
Page 72 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824213
Page 73 of 143
***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: 12181046 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: [ ]
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824214
Page 74 of 143
***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: 12181046 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/29/2021
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824215
Page 75 of 143
***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: 12181046 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
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824216
Page 76 of 143
***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: 12181046 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 15:30:10 (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.
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824217
Page 77 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-02-2020 13:33:27 (UTC-07:00) Mountain
Time (US & Canada)ALL inclusion criteria met
NO exclusion criteria met
Not Applicable
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824218
Page 78 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-02-2020 17:23:25 (UTC-07:00) Mountain
Time (US & Canada)2mL retain
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824219
Page 79 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-02-2020 17:24:15 (UTC-07:00) Mountain
Time (US & Canada)5mL retain
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824220
Page 80 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-02-2020 17:25:09 (UTC-07:00) Mountain
Time (US & Canada)send
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824221
Page 81 of 143
***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: 12181046 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 15:30:10 (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 12:03:35 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-29-2021 20:57:38 (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 11:56:37 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824222
Page 82 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Laura Hammit Approved Jan-23-2021 07:34:11 (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-11-2021 18:12:01 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Jan-11-2021 13:35:05 (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 Dec-21-2020 15:30:39 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit Approved Dec-04-2020 22:37:40 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824223
Page 83 of 143
***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: 12181046 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.
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824224
Page 84 of 143
***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: 12181046 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
Jan-22-2021 09:06:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-13-2021 14:54:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-13-2021 14:54:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Transcription Error
Jan-10-2021 18:37:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Confirm this was
the current protocol
when the subject
was enrolled.
Dec-02-2020 13:31:22
(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-02-2020 13:31:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0824225
Page 85 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-02-2020 13:31:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Dec/2/2020Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824226
Page 86 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-02-2020 13:31:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12181046Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Dec-02-2020 13:31:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-02-2020 13:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-02-2020 13:31:56
(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-02-2020 13:31:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AMERICAN INDIAN OR AL
ASKA NATIVEInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824227
Page 87 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021 00:19:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-19-2021 14:47:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Jan-19-2021 03:38:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
consider to update
missing HIV
STATUS form or
else clarify. Thank
you.
Dec-02-2020 13:32:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824228
Page 88 of 143
***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: 12181046 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-02-2020 13:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-02-2020 13:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-02-2020 13:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824229
Page 89 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Dec-02-2020 13:37:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Drug Allergy:
Sulfa
Start Date: Feb/4/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:37:02
(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-02-2020 13:37:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Drug Allergy: SulfaInitial Entry
1.a Start Date:
Date Location User Value Reason
Dec-02-2020 13:37:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Dec-02-2020 13:37:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824230
Page 90 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b
Date Location User Value Reason
Dec-02-2020 17:21:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 2
Medical History Te
rm:Rhinitis
Start Date: Mar/1/20
16
Ongoing: YESmultiple concepts
Dec-02-2020 13:37:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:Drug Allergy:
Rhinitis
Start Date: Mar/1/2016
Ongoing: YESInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824231
Page 91 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.b Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:37:36
(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-02-2020
19:06:44
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clos
edDiscrepancy
has been
closed.
Dec-02-2020
17:21:19
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredmultiple
concepts
Dec-02-2020
17:21:19
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Rhinitismultiple
concepts
Dec-02-2020
15:32:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Open
edMultiple
concepts in the
term DRUG
ALLERGY:
RHINITIS.
Split the term
into DRUG
ALLERGY
and
ALLERGIC
RHINITIS and
submit
separately.
Thank you.
Dec-02-2020
13:37:36
(UTC-07:00)ACV0PFEINFP6000 Data Entry:
Drug Allergy:
RhinitisInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824232
Page 92 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Mountain Time
(US & Canada)
1.b Start Date:
Date Location User Value Reason
Dec-02-2020 13:37:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Dec-02-2020 13:37:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Dec-02-2020 13:39:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Surgery: Left E
ye
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/
2012Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824233
Page 93 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:39:26
(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-02-2020 13:39:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Surgery: Left EyeInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-02-2020 13:39:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Dec-02-2020 13:39:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.d
Date Location User Value Reason
Dec-02-2020 13:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Surgery: Right
Knee
Start Date: UNK/UNK/198
8Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824234
Page 94 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Ongoing: NO
End Date:
UNK/UNK/
1988
1.d Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:40:20
(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-02-2020 13:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Surgery: Right KneeInitial Entry
1.d Start Date:
Date Location User Value Reason
Dec-02-2020 13:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.d Ongoing:
Date Location User Value Reason
Dec-02-2020 13:40:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.e
Date Location User Value Reason
Dec-02-2020 13:40:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824235
Page 95 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Medical History Ter
m:Glaucoma
Start Date: Apr/24/201
4
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:40:58
(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-02-2020 13:40:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GlaucomaInitial Entry
1.e Start Date:
Date Location User Value Reason
Dec-02-2020 13:40:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/24/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Dec-02-2020 13:40:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Dec-02-2020 13:41:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 6
Medical History Te
rm:DiabetesInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824236
Page 96 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Start Date: Jan/8/20
20
Ongoing: YES
Dec-02-2020 13:41:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Diabetes
Start Date: Jan/8/20
20
Ongoing:Initial Entry
1.f Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:41:18
(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-02-2020 13:41:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DiabetesInitial Entry
1.f Start Date:
Date Location User Value Reason
Dec-02-2020 13:41:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Dec-02-2020 13:41:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824237
Page 97 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-02-2020 13:41:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Obesity
Start Date: May/1/199
2
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:41:59
(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-02-2020 13:41:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.g Start Date:
Date Location User Value Reason
Dec-02-2020 13:41:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/1/1992Initial Entry
1.g Ongoing:
Date Location User Value Reason
Dec-02-2020 13:41:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Dec-02-2020 13:42:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824238
Page 98 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Medical History
Term:Detached Retin
a
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/
2012
1.h Line/MH Number:
Date Location User Value Reason
Dec-02-2020 13:42:36
(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-02-2020 13:42:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Detached RetinaInitial Entry
1.h Start Date:
Date Location User Value Reason
Dec-02-2020 13:42:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Dec-02-2020 13:42:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824239
Page 99 of 143
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-19-2021 14:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0824240
Page 100 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
119.9Initial Entry
3. Unit:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
175.5Initial Entry
5. Unit:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
38.9Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824241
Page 101 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7.a
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 96.9
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-04-2020 02:37:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
response.
Dec-03-2020 08:20:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered not clinically
significant
Dec-02-2020 21:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Confirmation
on the out of range
value as "clinically
significant" or "not
clinically
significant" is
expected as a
response. Please
review and confirm.
Dec-02-2020 13:36:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824242
Page 102 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.9 F
is outside of
Normal Range 97 -
99.5 F.
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96.9Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Dec-02-2020 13:34:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824243
Page 103 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-02-2020 13:35:16
(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-02-2020 13:35:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-02-2020 13:35:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-02-2020 13:35:16
(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-02-2020 13:35:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824244
Page 104 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-02-2020 13:35:16
(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-02-2020 13:35:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-02-2020 13:35:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Dec-02-2020 13:35:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824245
Page 105 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-02-2020 17:21:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-02-2020 17:21:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
117234Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824246
Page 106 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-02-2020 17:22:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-02-2020 17:22:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-02-2020 17:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-02-2020 17:22:25
(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-02-2020 17:22:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/2/2020Initial Entry
5.a
Date Location User Value Reason
Dec-02-2020 17:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72C9Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824247
Page 107 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-02-2020 17:22:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72C9Initial Entry
5.b
Date Location User Value Reason
Dec-02-2020 17:23:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72CBInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-02-2020 17:23:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72CBInitial Entry
5.c
Date Location User Value Reason
Dec-02-2020 17:24:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NVCInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-02-2020 17:24:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NVCInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824248
Page 108 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-02-2020 17:25:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-02-2020 17:25:30
(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-02-2020 17:25:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-02-2020 17:25:30
(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-02-2020 17:25:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/2/2020Initial Entry
5.a
Date Location User Value Reason
Dec-02-2020 17:25:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NV9Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824249
Page 109 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-02-2020 17:25:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NV9Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824250
Page 110 of 143
***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: 12181046 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-02-2020 13:35:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-02-2020 13:35:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-02-2020 13:35:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-21-2021 08:08:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 William
StewardQuery 1: Closed Response satisfies
query
Jan-11-2021 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-11-2021 18:12:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020 12:32Transcription Error
Jan-10-2021 18:51:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Source has 12:32.
Please review and
update as needed.
Dec-02-2020 13:35:46
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
Dec/2/2020 12:31Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824251
Page 111 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
5. Anatomical Location:
Date Location User Value Reason
Dec-02-2020 13:35:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-02-2020 13:35:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-02-2020 13:35:46
(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-02-2020 13:35:46
(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-02-2020 13:35:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0824252
Page 112 of 143
***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: 12181046 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-02-2020 13:35:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824253
Page 113 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-16-2021
03:50:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Clo
sedConfirmed As-Is
Feb-15-2021
13:21:31
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dWe have looked at
section 8.64 of CCG
and do not find
anything erroneous
in our data entry.
She was unblinded
on 28Dec2020 and
given VAX 2 on
28Dec2020.
Feb-15-2021
04:52:15
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dDM1: Thank you
per response.
However, please
refer section 8.64 of
CCG (FAQ 1
table)and update
data as appropriate.
Else, clarify. Thank
you.
Feb-11-2021
12:04:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dParticipant
unblinded at VAX2
visit as they were
eligible by local
recommendations to
receive vaccine. The
above date is
correct.
Feb-04-2021
06:21:39
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW7063238;The
Date of Visit at Visit
‘REVAX_CONT’ is
the same as the other
Date of Visit at Visit
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824254
Page 114 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Canada) ‘V2_VAX2_L’.
Please review for
duplication and
update as
appropriate.
Dec-29-2020
22:48:07
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedClosed per SITE
response, added to
PD tracker for
Clinical Review
Dec-29-2020
08:13:58
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dYes. Please note that
participant had an
SAE at the time of
her scheduled VAX
2 and was
hospitalized. She
was given her VAX
2 on the first
available day after
her recovery.
Dec-28-2020
22:24:34
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 3
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately.
Dec-28-2020
12:10:42
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Dec/2
8/202
0Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0824255
Page 115 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-28-2020 16:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020Initial Entry
2.a
Date Location User Value Reason
Dec-28-2020 16:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-28-2020 16:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-28-2020 16:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-28-2020 16:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824256
Page 116 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-28-2020 16:29:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824257
Page 117 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-28-2020 16:29:52
(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-28-2020 16:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-28-2020 16:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-28-2020 16:29:52
(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-28-2020 16:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824258
Page 118 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-28-2020 16:29:52
(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-28-2020 16:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-28-2020 16:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-28-2020 16:29:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824259
Page 119 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020 12:10:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020 12:10:56
(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-28-2020 12:11:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-28-2020 12:10:56
(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-28-2020 12:10:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-28-2020 12:11:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NYJInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824260
Page 120 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 12:11:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NYJInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824261
Page 121 of 143
***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: 12181046 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 16:31:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-28-2020 16:31:58
(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 16:31:58
(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 16:31:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020 10:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-28-2020 16:31:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-28-2020 16:31:58
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824262
Page 122 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-28-2020 16:31:58
(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 16:31:58
(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 16:31:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824263
Page 123 of 143
***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: 12181046 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-25-2021 08:59:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-22-2021 12:23:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This event was
already captured as
an SAE in
December. Do I
need to do
anything else?
Feb-20-2021 18:15:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Worksheet
confirms the
subject had an ER
visit, hospital
admission and
urgent care visit.
Please confirm
what this was for
and add AE/SAE
as needed.
Jan-29-2021 11:58:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0824264
Page 124 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 11:59:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 11:59:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 11:59:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 11:59:25
(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-29-2021 11:59:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 11:59:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8NK5Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824265
Page 125 of 143
***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: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 11:59:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8NK5Initial Entry
5.b
Date Location User Value Reason
Jan-29-2021 12:00:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72JJInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-29-2021 12:00:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72JJInitial Entry
5.c
Date Location User Value Reason
Jan-29-2021 12:00:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS72JHInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-29-2021 12:00:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS72JHInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824266
Page 126 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824267
Page 127 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824268
Page 128 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Acute CholecystitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/20/2020 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-28-2020 16:33:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:UNKNew Information
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824269
Page 129 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
6. Toxicity Grade:
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-22-2020 06:52:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Acute
Cholecystitis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YESInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824270
Page 130 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Acute cholecystitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824271
Page 131 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-28-2020 16:34:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-28-2020 16:34:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-28-2020 16:33:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Acute
Cholecystitis:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824272
Page 132 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-21-2020 15:30:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-06-2021 06:49:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020506377Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824273
Page 133 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-14-2021 17:17:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-14-2021 13:42:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-14-2021 13:42:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mature cystic teratoma left ovar
yNew Information
Jan-12-2021 13:33:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Clinical_ Subject
"underwent an
oophorectomy", was
there a final
diagnosis or
pathology report? If
so, kindly provide
this information in a
FU form. Thank
you.
Dec-21-2020 15:34:19
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
Pelvic massInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824274
Page 134 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
4. Start Date Time:
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-28-2020 16:37:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:UNKNew Information
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824275
Page 135 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Unknown-pelvic mass foun
d incidentally on abdomina
l ultrasoundInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824276
Page 136 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-29-2020 00:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed closed per data
updated by site.
Dec-28-2020 16:36:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Dec-28-2020 16:36:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-22-2020 01:09:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Per response,
kindly update
information once
available, change
query status to
answered when
data is updated.
Thank you.
Dec-21-2020 15:52:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered At this time, the
outcome is
unknown. We will
update this once we
have more
information on
what the plan will
be with this
incidental finding.
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Pelvic
mass: Response to
"What was the
outcome of this
adverse event?" is
'Unknown' but End
Date/Time is
provided or "Is the
adverse event still
ongoing?" is
marked "Yes".
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0824277
Page 137 of 143
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-21-2020 15:34:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824278
Page 138 of 143
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 12181046 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
Jan-29-2021 11:57:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-29-2021 11:57:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-29-2021 11:57:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0824279
Page 139 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 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-12-2021
03:03:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clos
edResponse satisfies
query
Feb-11-2021
12:04:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredParticipant
unblinded at VAX2
visit as they were
eligible by local
recommendations to
receive vaccine. The
above date is
correct.
Feb-01-2021
05:56:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7062984;The
Date of Visit at Visit
REVAX_CONTACT
is not in
chronological order
based on the visit
schedule. Please
review and update as
appropriate.
Jan-29-2021
11:56:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry:
Dec/28
/2020Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0824280
Page 140 of 143
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021 09:18:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-11-2021 23:03:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-11-2021 12:03:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-11-2021 12:03:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only plac
ebo at Vaccination 1/2Changed data to
reflect updated
guidance received
Jan-29-2021 11:56:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to r
eturn for Vaccination 3 OR oth
erwise not eligibleInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0824281
Page 141 of 143
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021 09:18:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021 09:18:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824282
Page 142 of 143
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-29-2021 11:57:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Dec-02-2020 17:21:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Dec-02-2020 13:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-29-2021 11:57:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/29/2021Initial Entry
Dec-02-2020 17:21:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/2/2020Initial Entry
Dec-02-2020 13:33:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/2/2020Initial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824283
Page 143 of 143
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181046 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-04-2020 12:04:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e99\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824284