125742 S1 M5 CRF c4591001 1141 11411113

Document text

Page 1 of 147
***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: 11411113 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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939816
Page 2 of 147
***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: 11411113 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/20/2020
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939817
Page 3 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11411113]
2.Birth Date: /1992
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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939818
Page 4 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939819
Page 5 of 147
***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: 11411113 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 MetNot Applicable
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939820
Page 6 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939821
Page 7 of 147
***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: 11411113 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:[Headaches]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939822
Page 8 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [85.4]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [29.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939823
Page 9 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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/20/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939824
Page 10 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [59610]
3.Randomization Group: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939825
Page 11 of 147
***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: 11411113 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/20/2020
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 [BM88LS]
5.bSample ID [BM88LT]
5.cSample ID [BM88LV]
5.dSample ID [BLC994]
5.eSample ID [BLC995]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939826
Page 12 of 147
***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: 11411113 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/20/2020
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 [BM88LM]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939827
Page 13 of 147
***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: 11411113 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/20/2020 16:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939828
Page 14 of 147
***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: 11411113 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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939829
Page 15 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939830
Page 16 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939831
Page 17 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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/11/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939832
Page 18 of 147
***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: 11411113 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/11/2020
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 [BM6HXT]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939833
Page 19 of 147
***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: 11411113 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/11/2020 13:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939834
Page 20 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939835
Page 21 of 147
***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: 11411113 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/9/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9M6D]
5.bSample ID [BRX6YL]
5.cSample ID [BRX6YM]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939836
Page 22 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939837
Page 23 of 147
***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: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939838
Page 24 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939839
Page 25 of 147
***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: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939840
Page 26 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939841
Page 27 of 147
***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: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939842
Page 28 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939843
Page 29 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939844
Page 30 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939845
Page 31 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939846
Page 32 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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?
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939847
Page 33 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939848
Page 34 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939849
Page 35 of 147
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939850
Page 36 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939851
Page 37 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939852
Page 38 of 147
***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: 11411113 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/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939853
Page 39 of 147
***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: 11411113 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: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939854
Page 40 of 147
***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: 11411113 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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939855
Page 41 of 147
***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: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939856
Page 42 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  injection site pain
 Sep/11/20
20 18:00 NO
End Date Time:
Sep/14/2020 08:0
0
 Repeating
Pages
 2.ADVERSE
EVENT 2  swollen left axilla
ry lymph node Sep/12/20
20 08:00 NO
End Date Time:
Sep/14/2020 08:0
0
 Repeating
Pages
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939857
Page 43 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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)[injection site pain]
4.Start Date Time: Sep/11/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/14/2020 08:00
6.Toxicity Grade: 1
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939858
Page 44 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939859
Page 45 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939860
Page 46 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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)[swollen left axillary lymph node]
4.Start Date Time: Sep/12/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/14/2020 08:00
6.Toxicity Grade: 1
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939861
Page 47 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939862
Page 48 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939863
Page 49 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939864
Page 50 of 147
***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: 11411113 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[ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939865
Page 51 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.[ ]      [ ]    Repeating
Pages
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939866
Page 52 of 147
***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: 11411113 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: //
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939867
Page 53 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939868
Page 54 of 147
***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: 11411113 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?
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939869
Page 55 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939870
Page 56 of 147
***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: 11411113 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?
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939871
Page 57 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939872
Page 58 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939873
Page 59 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939874
Page 60 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11411113 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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939875
Page 61 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939876
Page 62 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11411113 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?
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939877
Page 63 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939878
Page 64 of 147
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939879
Page 65 of 147
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939880
Page 66 of 147
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939881
Page 67 of 147
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939882
Page 68 of 147
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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 [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939883
Page 69 of 147
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939884
Page 70 of 147
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939885
Page 71 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/8/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939886
Page 72 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939887
Page 73 of 147
***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: 11411113 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: [ ]
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939888
Page 74 of 147
***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: 11411113 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/9/2020
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939889
Page 75 of 147
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939890
Page 76 of 147
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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-24-2021 08:00:59 (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.
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939891
Page 77 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-21-2020 06:06:26 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939892
Page 78 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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-24-2021 08:00:59 (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-19-2021 09:24:41 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Feb-18-2021 12:51:50 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939893
Page 79 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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-18-2021 10:14:11 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Dec-01-2020 11:44:42 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939894
Page 80 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 Nov-23-2020 11:00:18 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Nov-16-2020 15:17:42 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939895
Page 81 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 Nov-16-2020 15:03:48 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Winokur Approved Oct-22-2020 16:03:18 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939896
Page 82 of 147
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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.
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939897
Page 83 of 147
***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: 11411113 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-20-2020
17:52:26
(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-20-2020
17:52:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939898
Page 84 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020
17:52:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/20/2020Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939899
Page 85 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020
17:52:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11411113Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020
17:52:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1992Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020
17:52:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939900
Page 86 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-20-2020
17:52:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020
17:52:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939901
Page 87 of 147
***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: 11411113 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-20-2020
17:52:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939902
Page 88 of 147
***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: 11411113 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-20-2020
17:53:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020
17:53:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020
17:53:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939903
Page 89 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020
18:09:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Headach
es
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020
18:09:49
(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-20-2020
18:09:49
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
HeadachesInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939904
Page 90 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-20-2020
18:09:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020
18:09:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939905
Page 91 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
85.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939906
Page 92 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.6Initial Entry
7.a
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Record Ide 1Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939907
Page 93 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)ntifier::
Temperatu
re:98.4
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939908
Page 94 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020
21:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939909
Page 95 of 147
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020
21:09:56
(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-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939910
Page 96 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-20-2020
21:09:56
(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-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939911
Page 97 of 147
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020
21:09:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939912
Page 98 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020
21:10:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020
21:10:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
59610Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939913
Page 99 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020
21:10:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
21:10:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020
06:06:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-21-2020
02:58:26ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939914
Page 100 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-20-2020
21:10:18
(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-20-2020
21:10:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
06:06:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88LSInitial Entry
5.a Sample ID
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939915
Page 101 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-21-2020
06:06:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM88LSInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020
06:06:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88LTInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020
06:06:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM88LTInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020
06:06:52
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
Sample ID: BM88LVInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939916
Page 102 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)
5.c Sample ID
Date Location User Value Reason
Aug-21-2020
06:06:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM88LVInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020
06:06:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC994Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-21-2020
06:06:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLC994Initial Entry
5.e
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939917
Page 103 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-21-2020
06:07:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLC995Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-21-2020
06:07:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLC995Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939918
Page 104 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020
21:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
21:10:24
(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-21-2020
06:07:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-21-2020
02:58:26ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939919
Page 105 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-20-2020
21:10:24
(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-20-2020
21:10:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
06:07:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM88L
MInitial Entry
5.a Sample ID
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939920
Page 106 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-21-2020
06:07:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM88LMInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939921
Page 107 of 147
***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: 11411113 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-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939922
Page 108 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020 16:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020
21:10:42
(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-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939923
Page 109 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-20-2020
21:10:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939924
Page 110 of 147
***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: 11411113 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-20-2020
21:10:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939925
Page 111 of 147
***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: 11411113 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-11-2020
16:12:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939926
Page 112 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020
16:13:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020
16:13:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.1
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020
16:13:40
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939927
Page 113 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-11-2020
16:13:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-11-2020
16:13:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
16:13:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939928
Page 114 of 147
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-11-2020
16:13:51
(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-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939929
Page 115 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-11-2020
16:13:51
(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-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939930
Page 116 of 147
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Sep-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-11-2020
16:13:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939931
Page 117 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
13:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
13:26:39
(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-11-2020
13:26:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
13:26:39ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939932
Page 118 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
13:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
13:26:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM6HX
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
13:26:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM6HXTInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939933
Page 119 of 147
***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: 11411113 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-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939934
Page 120 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 13:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
16:14:25
(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-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939935
Page 121 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-11-2020
16:14:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939936
Page 122 of 147
***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: 11411113 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-09-2020
10:23:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939937
Page 123 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020
10:23:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020
10:23:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020
15:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-09-2020
10:23:35ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939938
Page 124 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-09-2020
10:23:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020
15:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP9M6
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020
15:08:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9M6DInitial Entry
5.b
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939939
Page 125 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRX6Y
LInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020
15:08:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRX6YLInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020
15:09:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRX6Y
MInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939940
Page 126 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Oct-09-2020
15:09:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRX6YMInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939941
Page 127 of 147
***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: 11411113 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-09-2020
10:23:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020
10:23:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020
10:23:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939942
Page 128 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939943
Page 129 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939944
Page 130 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020
15:03:48
(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
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
injection site painInitial Entry
4. Start Date Time:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939945
Page 131 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/14/2020 08:0
0Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
15:03:48
(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;
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939946
Page 132 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-16-2020
15:03:48
(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
Nov-16-2020
15:03:48
(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
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939947
Page 133 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020
15:03:48
(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
Nov-16-2020
15:03:48
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939948
Page 134 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020
15:03:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939949
Page 135 of 147
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020
15:05:33
(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
Nov-23-2020
11:52:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response
satisfies query
Nov-23-2020 ACV0PFEINFP6000  auto query Query 1: Answered New
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939950
Page 136 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11:00:18
(UTC-06:00)
Central Time (US
& Canada)(autoquery) Information
Nov-23-2020
11:00:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
swollen left axillar
y lymph nodeNew
Information
Nov-23-2020
02:58:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN:
Please update
the verbatim
term to
include if
swollen
axillary lymph
node is left,
right or
bilateral.
Thank you.
Nov-19-2020
20:34:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Patricia
BancheroQuery 1: Candidate GPDCLIN:
Please update
the verbatim
term to
include if
swollen
axillary lymph
node is left,
right or
bilateral.
Thank you.
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939951
Page 137 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
swollen axillary ly
mph nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/12/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/14/2020 08:0
0Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939952
Page 138 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-16-2020
15:05:33
(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
Nov-16-2020
15:05:33
(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
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939953
Page 139 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939954
Page 140 of 147
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
& Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020
15:05:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939955
Page 141 of 147
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
10:14:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939956
Page 142 of 147
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 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-19-2021
09:24:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-18-2021
21:23:10
(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.
Feb-18-2021
10:14:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939957
Page 143 of 147
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
visit. Please
complete this
date.
Feb-18-2021
10:14:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have received
only placebo at
Vaccination 1/2Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939958
Page 144 of 147
***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: 11411113 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-19-2021
09:24:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-19-2021
09:24:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONAL
VACCINATIONInitial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939959
Page 145 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020
10:23:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020
21:10:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-20-2020
17:53:02
(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-09-2020
10:23:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-20-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939960
Page 146 of 147
***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: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
21:10:08
(UTC-06:00)
Central Time (US
& Canada)(autocalc) Aug/20/2020
Aug-20-2020
17:53:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
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090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1141 Site Name: (1141) University of Iowa Hospital and
Clinics
Subject No: 11411113 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
09:02:32
(UTC-06:00)
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090177e196ae40c3\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0939962