Document text
Page 1 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is
equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What cohort
does the subject belong to?STAGE 3 COHORTS
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940172
Page 2 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940173
Page 3 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11411143]
2.Birth Date: /1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940174
Page 4 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940175
Page 5 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion Met Not Applicable
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940176
Page 6 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940177
Page 7 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[seasonal affective disorder]
Start Date: UNK/UNK/1999
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[insomnia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[generalized pain]
Start Date: UNK/UNK/1980
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[nearsighted]
Start Date: UNK/UNK/1975
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[right hip osteoarthritis]
Start Date: Apr/UNK/2018
Ongoing: NO
End Date:
May/29/2018
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940178
Page 8 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[right hip replacement]
Start Date: May/29/2018
Ongoing: NO
End Date:
May/29/2018
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[degenerative disk disease- back]
Start Date: Jan/UNK/2007
Ongoing: NO
End Date:
Mar/29/2007
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Rods placed in back]
Start Date: Mar/29/2007
Ongoing: NO
End Date:
Mar/29/2007
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[tummy tuck]
Start Date: Apr/UNK/2017
Ongoing: NO
End Date:
Apr/UNK/2017
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[abdominal apron]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
Apr/UNK/2017
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[lower back pain (L5 Region)]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940179
Page 9 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[post menopausal]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940180
Page 10 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [86.0]
3.Unit: kg
4.Height: [157.0]
5.Unit: cm
6.Body Mass Index: [34.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940181
Page 11 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and Address (Derived) [STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940182
Page 12 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [241295]
3.Randomization Group: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940183
Page 13 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BM88SV]
5.bSample ID [BM88SW]
5.cSample ID [BM88SX]
5.dSample ID [BLC9C3]
5.eSample ID [BLC9C2]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940184
Page 14 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BM88SP]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940185
Page 15 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 15:09
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
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940186
Page 16 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940187
Page 17 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940188
Page 18 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940189
Page 19 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and Address (Derived) [STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940190
Page 20 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BM6J0X]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940191
Page 21 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 10:50
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
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940192
Page 22 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940193
Page 23 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BP9M91]
5.bSample ID [BRX71W]
5 cSample ID [BRX71W ]
5.dSample ID [BRX71X]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940194
Page 24 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940195
Page 25 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940196
Page 26 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940197
Page 27 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940198
Page 28 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940199
Page 29 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940200
Page 30 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940201
Page 31 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940202
Page 32 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Collection Specimen Type Specimen Collection Location Assay Code and Description Device Type Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940203
Page 33 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940204
Page 34 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940205
Page 35 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940206
Page 36 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940207
Page 37 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940208
Page 38 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940209
Page 39 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940210
Page 40 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940211
Page 41 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940212
Page 42 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab Tes
tVendor Nam
eCollection Date
:Specimen Typ
eLab Result Form Instance
1. Sponsor-Defined Identifie
rTest
:Result
:Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940213
Page 43 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940214
Page 44 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab T
estVendor Name (DERIV
ED)Collection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940215
Page 45 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940216
Page 46 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940217
Page 47 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in respirations/minute: [ ]
Heart Rate in beats/minute: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940218
Page 48 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940219
Page 49 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940220
Page 50 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940221
Page 51 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940222
Page 52 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Identif
ierCategory for Medicati
onConcomitant Medications Pre-spec
ifiedName of Medicati
onStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940223
Page 53 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter the
full trade or proprietary name. Include
clarifying information in the Medication
text (e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940224
Page 54 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940225
Page 55 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940226
Page 56 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940227
Page 57 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940228
Page 58 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940229
Page 59 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940230
Page 60 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/22/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Subject reported Covid illness symptom on Illness Diary. Subject had headache, chills, fatigue,
reports improvement in symptoms. Vaccine related per PI.]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940231
Page 61 of 165
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940232
Page 62 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940233
Page 63 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940234
Page 64 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940235
Page 65 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Category AE Identifier Adverse Event Start Date Is the Adverse Event Still Ongoing Form Instance
1.ADVERSE EVENT 1 Headache Sep/19/2020 03:00 NO
End Date Time:
Sep/20/2020 08:00
Repeating Pages
2.ADVERSE EVENT 2 Chills Sep/19/2020 03:00 NO
End Date Time:
Sep/20/2020 08:00
Repeating Pages
3.ADVERSE EVENT 3 Fatigue Sep/19/2020 09:00 NO
End Date Time:
Sep/20/2020 08:00
Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940236
Page 66 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Headache]
4.Start Date Time: Sep/19/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 08:00
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: RELATED
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[ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940237
Page 67 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Chills]
4.Start Date Time: Sep/19/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 08:00
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: RELATED
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[ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940238
Page 68 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Sep/19/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 08:00
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: RELATED
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[ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940239
Page 69 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category Medication Error Start Date Is the medication error Still Ongoing Study Medication Errors Action Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940240
Page 70 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the subject
to be discontinued from the study?
9.Was this medication error associated with
any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940241
Page 71 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Identif
ierCategory for Medicati
onConcomitant Medications Pre-spec
ifiedName of Medicati
onStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940242
Page 72 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter the
full trade or proprietary name. Include
clarifying information in the Medication
text (e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940243
Page 73 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionDose Descripti
onForm Instance
1. Repeating
Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940244
Page 74 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter the
full trade or proprietary name. Include
clarifying information in the Medication
text (e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940245
Page 75 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940246
Page 76 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940247
Page 77 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940248
Page 78 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940249
Page 79 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940250
Page 80 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940251
Page 81 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address (Derived) [ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940252
Page 82 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period after
investigational product administration?
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940253
Page 83 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940254
Page 84 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940255
Page 85 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940256
Page 86 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940257
Page 87 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940258
Page 88 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample was
not collected according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940259
Page 89 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940260
Page 90 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is participant
willing to return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940261
Page 91 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940262
Page 92 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940263
Page 93 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of Death: //
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940264
Page 94 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940265
Page 95 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940266
Page 96 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia Winokur Approved Feb-12-2021 12:57:52 (UTC-06:00) Central Time (US
& Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, 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.
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940267
Page 97 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-28-2020 05:26:35 (UTC-06:00) Central Time (US &
Canada)Not Applicable
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940268
Page 98 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia Winokur Approved Feb-12-2021 12:57:52 (UTC-06:00) Central Time (US
& Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, 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-09-2021 10:50:10 (UTC-06:00) Central Time (US
& Canada)Edit - All signatures
invalidated
Affidavit:
N/A
Patricia Winokur Approved Feb-01-2021 11:19:05 (UTC-06:00) Central Time (US &
Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, 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-28-2021 11:02:11 (UTC-06:00) Central Time (US &
Canada)Edit - All signatures
invalidated
Affidavit:
N/A
Patricia Winokur Approved Oct-30-2020 18:12:20 (UTC-06:00) Central Time (US &
Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, 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.
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940269
Page 99 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
N/A Oct-30-2020 15:29:08 (UTC-06:00) Central Time (US &
Canada)Edit - All signatures
invalidated
Affidavit:
N/A
Patricia Winokur Approved Oct-30-2020 10:36:57 (UTC-06:00) Central Time (US &
Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaWinokur, 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.
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0940270
Page 100 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 05:26:01
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 05:26:01
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940271
Page 101 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 05:26:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940272
Page 102 of 165
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 05:25:53
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11411143Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 05:25:50
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 05:26:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 05:26:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 05:26:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940273
Page 103 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 05:26:28
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940274
Page 104 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 05:26:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 05:26:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 05:26:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940275
Page 105 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 05:27:24
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: hypertension
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:27:24
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:27:24
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 05:27:24
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 05:27:24
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020 05:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:seasonal affective diso
rder
Start Date: UNK/UNK/1999
Ongoing: YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940276
Page 106 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
seasonal affective disorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 05:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 05:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-28-2020 05:28:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term: insomnia
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940277
Page 107 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:28:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:28:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 05:28:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 05:28:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-28-2020 05:28:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: generalized pain
Start Date: UNK/UNK/1980
Ongoing: YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940278
Page 108 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:28:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:28:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
generalized painInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 05:28:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 05:28:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-28-2020 05:28:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Term: nearsighted
Start Date: UNK/UNK/1975
Ongoing: YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940279
Page 109 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:28:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:28:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
nearsightedInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 05:28:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 05:28:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-28-2020 05:29:59
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 6
Medical History Ter
m:right hip osteoarthrit
is
Start Date: Apr/UNK/2018
Ongoing: NO
End Date:
May/29/2018Transcription Error
Aug-28-2020 05:29:43
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 6
Medical History Ter
m:right hip osteoarthrit
is
Start Date: Apr/UNK/2018
Ongoing: NO
End Date:
May/19/2018Transcription Error
Aug-28-2020 05:29:27 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940280
Page 110 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central Time (US
& Canada)(autocalc) Line/MH Number: 6
Medical History Ter
m:right hip osteoarthrit
is
Start Date: Apr/UNK/2018
Ongoing: NO
End Date:
May/19/2010
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940281
Page 111 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:29:27
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:29:27
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
right hip osteoarthritisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 05:29:27
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 05:29:59
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/29/2018Transcription Error
Aug-28-2020 05:29:43
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 05:29:43
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/19/2018Transcription Error
Aug-28-2020 05:29:27
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Term right hip
osteoarthritis End Date is
prior to Start Date.
Aug-28-2020 05:29:27
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/19/2010Initial Entry
1.g
Date Location User Value Reason
Aug-28-2020 05:30:37
(UTC-06:00) Central Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940282
Page 112 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
& Canada) Line/MH Number: 7
Medical History Ter
m:right hip replaceme
nt
Start Date: May/29/2018
Ongoing: NO
End Date:
May/29/2018
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:30:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:30:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
right hip replacementInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020 05:30:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/29/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020 05:30:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/29/2018Initial Entry
1.h
Date Location User Value Reason
Aug-28-2020 05:31:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:degenerative disk diseas
e- back
Start Date: Jan/UNK/2007
Ongoing: NO
End Date:
Mar/29/2007Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940283
Page 113 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:31:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:31:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
degenerative disk disease- backInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-28-2020 05:31:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2007Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-28-2020 05:31:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/29/2007Initial Entry
1.i
Date Location User Value Reason
Aug-28-2020 05:32:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Term
:Rods placed in bac
k
Start Date: Mar/29/2007
Ongoing: NO
End Date:
Mar/29/2007Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940284
Page 114 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:32:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:32:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Rods placed in backInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-28-2020 05:32:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/29/2007Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940285
Page 115 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.i Ongoing:
Date Location User Value Reason
Aug-28-2020 05:32:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/29/2007Initial Entry
1.j
Date Location User Value Reason
Aug-28-2020 05:32:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Term: tummy tuck
Start Date: Apr/UNK/2017
Ongoing: NO
End Date:
Apr/UNK/2017Initial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:32:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:32:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
tummy tuckInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-28-2020 05:32:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-28-2020 05:32:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2017Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940286
Page 116 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.k
Date Location User Value Reason
Aug-28-2020 05:33:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Term: abdominal apron
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
Apr/UNK/2017Initial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:33:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:33:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
abdominal apronInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-28-2020 05:33:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-28-2020 05:33:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2017Initial Entry
1.l
Date Location User Value Reason
Aug-28-2020 05:33:35
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:lower back pain (L5 R
egion)
Start Date: UNK/UNK/2007Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940287
Page 117 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:33:35
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:33:35
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
lower back pain (L5 Region)Initial Entry
1.l Start Date:
Date Location User Value Reason
Aug-28-2020 05:33:35
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-28-2020 05:33:35
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-28-2020 05:33:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Term: post menopausal
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940288
Page 118 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.m Line/MH Number:
Date Location User Value Reason
Aug-28-2020 05:33:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 05:33:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
post menopausalInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-28-2020 05:33:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-28-2020 05:33:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940289
Page 119 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
86.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
157.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
34.9Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 96.1
Temperature Unit: FInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940290
Page 120 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Temperature Location:: ORAL CAVITY
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020 04:45:48
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Aug-28-2020 08:10:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Original value is correct
Aug-28-2020 07:24:54
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Confirmation on the
out of range value as
clinically significant or
not is expected. Please
review and confirm.
Thank you.
Aug-28-2020 05:35:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Original value is correct
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.1 F is
outside of Normal Range
97 - 99.5 F.
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
96.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 05:34:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940291
Page 121 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:113
Test:: Choriogonadotropin B
eta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940292
Page 122 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-28-2020 05:34:41
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940293
Page 123 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 05:34:57
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 05:34:57
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
241295Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940294
Page 124 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 05:35:04
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 05:35:04
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 06:06:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 05:35:04
(UTC-06:00) Central 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.
Aug-28-2020 05:35:04
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 06:06:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM88SVInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 06:06:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM88SVInitial Entry
5.b
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940295
Page 125 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 06:06:17
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM88SWInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 06:06:17
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM88SWInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 06:06:29
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM88SXInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 06:06:29
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM88SXInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 06:06:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLC9C3Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 06:06:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLC9C3Initial Entry
5.e
Date Location User Value Reason
Aug-28-2020 06:06:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLC9C2Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940296
Page 126 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 06:06:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLC9C2Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940297
Page 127 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 05:35:13
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 05:35:13
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 06:06:56
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 05:35:13
(UTC-06:00) Central 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.
Aug-28-2020 05:35:13
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 06:06:56
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM88SPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 06:06:56
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM88SPInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940298
Page 128 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 15:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940299
Page 129 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERVAT
ION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-28-2020 05:35:44
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940300
Page 130 of 165
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 05:35:50
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY NOT
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940301
Page 131 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 13:27:22
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940302
Page 132 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 13:27:32
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 13:27:32
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 99.0
Temperature Unit: F
Temperature Location:: ORAL CAVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 13:27:32
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 13:27:32
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
99.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 13:27:32
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 13:27:32
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940303
Page 133 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:113
Test:: Choriogonadotropin B
eta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940304
Page 134 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-18-2020 13:27:51
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940305
Page 135 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 12:09:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 12:09:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 12:09:54
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 12:09:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and correct
as appropriate.
Sep-18-2020 12:09:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 12:09:54
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM6J0XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 12:09:54
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM6J0XInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940306
Page 136 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 10:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940307
Page 137 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERVAT
ION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-18-2020 13:28:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0940308
Page 138 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 16:14:10
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940309
Page 139 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 16:14:17
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 16:14:17
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 06:22:05
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 16:14:17
(UTC-06:00) Central 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.
Oct-19-2020 16:14:17
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 06:22:05
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9M91Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 06:22:05
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9M91Initial Entry
5.b
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0940310
Page 140 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-20-2020 06:22:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX71WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 06:22:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRX71WInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 06:22:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX71WTranscription Error
(DELETED)
Oct-20-2020 06:22:21
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX71WInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 06:22:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRX71WTranscription Error
(DELETED)
Oct-20-2020 06:22:21
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRX71WInitial Entry
5.d
Date Location User Value Reason
Oct-20-2020 06:22:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX71XInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-20-2020 06:22:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRX71XInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (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)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0940311
Page 141 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020 00:47:10
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Deleted Per SITE response 'This
was entered in error. The
erroneous visit was
ticked'
Oct-01-2020 00:45:14
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Data updated.
Sep-30-2020 11:55:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered This was entered in
error. The erroneous visit
was ticked
Sep-30-2020 11:54:45
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate Erroneous Visit is
marked, but date of visit
is entered. Please check
whether other
assessments are
performed at this visit.
Sep-27-2020 02:56:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Sep-27-2020 02:55:54
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened RQ-1: As this visit is
entered in error, Please
tick the radio button to
indicate that the visit
entry is erroneous
Sep-26-2020 09:51:23
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Please advise how to
delete this entry, this was
entered in error thanks
Sep-26-2020 09:49:43
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered This Covid entry was
entered in error please
advise how to go in and
delete this on database.
Sep-26-2020 04:12:04
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Date of Visit is
completed but Date of
Collection in both Nasal
Swab Self and Nasal
Swab are missing. Please
review and update as
appropriate. Thank you.
Sep-26-2020 04:11:39
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened DM: Date of Visit is
completed but Date of
Assessment in the Signs
and Symptoms form is
missing. Please review
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(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)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940312
Page 142 of 165
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
and update as
appropriate. Thank you.
Sep-25-2020 12:43:19
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the Signs
and Symptoms form is
missing. Please review
and update as
appropriate.
Sep-25-2020 12:43:19
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both Nasal
Swab Self and Nasal
Swab are missing. Please
review and update as
appropriate.
Sep-25-2020 12:43:19
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Sep-30-2020 11:54:45
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Sep-25-2020 12:43:19
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940313
Page 143 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020 03:31:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Oct-30-2020 16:03:37
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered contact clinic note was
documented in chart,
created an unplanned
source document as well
to reflect this contact.
Oct-27-2020 02:39:14
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened DM: Per earlier query
response, it seems this
visit initiate in error. If
correct select this visit as
Erroneous visit, else
update UNPL form.
Thank you.
Oct-26-2020 05:48:43
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-25-2020 10:28:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Entered in error please
advise how to delete
thanks
Oct-12-2020 22:47:07
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please update
UNPL form or else
clarify. Thank you.
Sep-24-2020 10:54:40
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940314
Page 144 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Assessments
Date Location User Value Reason
Oct-30-2020 16:02:56
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Oct-30-2020 15:29:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate 'Contact Outcome is
ticked however
'CONTACT OUTCOME'
form is not entered.
Please review and update
as appropriate.
Oct-30-2020 15:29:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
Oct-20-2020 11:51:13
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-20-2020 11:51:13
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Oct-20-2020 11:49:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Contact Outcome is
ticked however
'CONTACT OUTCOME'
form is not entered.
Please review and update
as appropriate.
Oct-20-2020 11:49:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
Sep-25-2020 12:42:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-25-2020 12:42:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-25-2020 06:55:31
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened 'Contact Outcome is
ticked however
'CONTACT OUTCOME'
form is not entered.
Please review and update
as appropriate.
Sep-24-2020 10:54:48
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT OUTCOME'
form is not entered.
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (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-2021-5683-0940315
Page 145 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Please review and update
as appropriate.
Sep-24-2020 10:54:48
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940316
Page 146 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-30-2020 16:02:56
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Oct-30-2020 16:02:56
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Sep/22/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGAT
OR DECISIONInitial Entry
3. Comments:
Date Location User ValueReason
Nov-15-2020
12:58:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Del
etedQuery is invalid or does not apply
Nov-07-2020
14:53:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Can
didateWe can leave the unplanned contact
outcome. AEs have been recorded in the
correct location. A covid illness visit needs
to be scheduled and symptoms will need to
be added to the ediary when the patient
comes in. Hold query discuss further
Nov-07-2020
14:51:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Nov-07-2020
12:14:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM Query: We can leave the unplanned
contact outcome. AEs have been recorded
in the correct location. A covid illness visit
needs to be scheduled and symptoms will
need to be added to the ediary when the
patient comes in.
Nov-06-2020 ACV0PFEINFP6000 Querythis is recorded in AE section please advise
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0940317
Page 147 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on Sep/22/2020 Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
15:14:33
(UTC-06:00)
Central Time
(US &
Canada)1: Ans
weredhow to reconcile delete this unplanned
contact eCRF? thanks
Nov-05-2020
12:04:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Ope
nedThe following text was indicated in the
comment field [Covid illness
symptom,headache,chills,fatigue,improvem
ent in symptoms]. For any symptoms, AEs,
or other key data should be collected on the
appropriate page or eDiary. If this is
already in the predefined list above please
choose the appropriate value. Please review
and update as necessary.
Oct-30-2020
16:02:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Subje
ct rep
orted
Covid
illness
sympt
om on
Illness
Diary.
Subje
ct had
heada
che, c
hills, f
atigue,
report
s impr
oveme
nt in s
ympto
ms. V
accine
relate
d per
PI.Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0940318
Page 148 of 165
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020 16:14:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 16:14:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 16:14:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940319
Page 149 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940320
Page 150 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940321
Page 151 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940322
Page 152 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central 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
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/19/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central 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
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940323
Page 153 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-25-2020 05:55:30
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-24-2020 11:22:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-24-2020 11:22:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDNew Information
Oct-21-2020 00:25:00
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response for
"Is this event related to
study treatment" is
missing. Kindly review
and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (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)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940324
Page 154 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 16:15:15
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940325
Page 155 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central 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
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/19/2020 03:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central 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;
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940326
Page 156 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-25-2020 05:55:53
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-24-2020 11:29:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-24-2020 11:29:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDNew Information
Oct-21-2020 00:25:12
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response for
"Is this event related to
study treatment" is
missing. Kindly review
and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (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)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940327
Page 157 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 16:15:58
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940328
Page 158 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/19/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central 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;
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940329
Page 159 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-25-2020 05:56:09
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-24-2020 11:29:26
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-24-2020 11:29:26
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
Oct-21-2020 00:25:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response for
"Is this event related to
study treatment" is
missing. Kindly review
and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(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-2021-5683-0940330
Page 160 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 16:16:34
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0940331
Page 161 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 11:02:11
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0940332
Page 162 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-09-2021 10:50:10
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-28-2021 21:18:30
(UTC-06:00) Central 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.
Jan-28-2021 11:02:17
(UTC-06:00) Central 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.
Jan-28-2021 11:02:17
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vaccinati
on 3
Participant is:
eligible and NOT confirmed to have rec
eived only placebo at Vaccination 1/2Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0940333
Page 163 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-09-2021 10:50:10
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-09-2021 10:50:10
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0940334
Page 164 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-19-2020 16:14:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 05:34:57
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 05:26:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-19-2020 16:14:25
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-28-2020 05:34:57
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-28-2020 05:26:46
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0940335
Page 165 of 165
***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics
Subject No: 11411143 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-30-2020 05:54:08
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae408e\Final\Final On: 01-Apr-2021 05:42 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0940336