Document text
Page 1 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921177
Page 2 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/14/2020
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921178
Page 3 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10901384]
2.Birth Date: 1979
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:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0921179
Page 4 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921180
Page 5 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921181
Page 6 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921182
Page 7 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/1985
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis]
Start Date: UNK/UNK/2002
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stress Urinary Incontinence]
Start Date: UNK/UNK/2009
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acne]
Start Date: UNK/UNK/1994
Ongoing: YES
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921183
Page 8 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2007
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ear Tube Implantation]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1983
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921184
Page 9 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [78.5]
3.Unit: kg
4.Height: [167.5]
5.Unit: cm
6.Body Mass Index: [28.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921185
Page 10 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/14/2020
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:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921186
Page 11 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [89539]
3.Randomization Group: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921187
Page 12 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BLB7PJ]
5.bSample ID [BLB7PK]
5.cSample ID [BP8F7C]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921188
Page 13 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP8F7D]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921189
Page 14 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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/14/2020 11:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921190
Page 15 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921191
Page 16 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921192
Page 17 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921193
Page 18 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/6/2020
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:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921194
Page 19 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BP8FJP]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921195
Page 20 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: Oct/6/2020 11:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921196
Page 21 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921197
Page 22 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCBFP]
5.bSample ID [BSN4LV]
5.cSample ID [BSN4LT]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921198
Page 23 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921199
Page 24 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921200
Page 25 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921201
Page 26 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921202
Page 27 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921203
Page 28 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921204
Page 29 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921205
Page 30 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921206
Page 31 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921207
Page 32 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921208
Page 33 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921209
Page 34 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921210
Page 35 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921211
Page 36 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921212
Page 37 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921213
Page 38 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921214
Page 39 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921215
Page 40 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921216
Page 41 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921217
Page 42 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921218
Page 43 of 146
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 hemorrhagic cyst on Ri
ght ovary Dec/7/2020 UN
K:UNK NO
End Date Time:
Dec/12/2020 UNK:UN
K
Repeating
Pages
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921219
Page 44 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[hemorrhagic cyst on Right ovary]
4.Start Date Time: Dec/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/12/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921220
Page 45 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[2021148721]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921221
Page 46 of 146
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921222
Page 47 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921223
Page 48 of 146
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Flu vaccine Oct/28/2
020 Repeating
Pages
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921224
Page 49 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Flu vaccine]
5.Date: Oct/28/2020
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921225
Page 50 of 146
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921226
Page 51 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921227
Page 52 of 146
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921228
Page 53 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921229
Page 54 of 146
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921230
Page 55 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921231
Page 56 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921232
Page 57 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921233
Page 58 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921234
Page 59 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921235
Page 60 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921236
Page 61 of 146
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921237
Page 62 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921238
Page 63 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/11/2021
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921239
Page 64 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8GCC]
5.bSample ID [BS1D84]
5.cSample ID [BS1D83]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921240
Page 65 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8GCJ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921241
Page 66 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/25/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921242
Page 67 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/25/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BV0FD9]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921243
Page 68 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/11/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921244
Page 69 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTWT76]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921245
Page 70 of 146
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921246
Page 71 of 146
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921247
Page 72 of 146
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921248
Page 73 of 146
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921249
Page 74 of 146
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921250
Page 75 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921251
Page 76 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921252
Page 77 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lisa Cohen Approved Mar-12-2021 08:53:38 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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.
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921253
Page 78 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-14-2020 16:45:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921254
Page 79 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lisa Cohen Approved Mar-12-2021 08:53:38 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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 Mar-11-2021 15:15:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Mar-01-2021 17:01:17 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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-28-2021 20:51:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0921255
Page 80 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Matthew Hong Approved Feb-25-2021 16:24:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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-25-2021 16:20:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-17-2021 12:36:30 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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-16-2021 17:10:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-16-2021 15:09:46 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0921256
Page 81 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, 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-16-2021 03:34:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-15-2021 17:40:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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-15-2021 15:03:17 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-12-2021 16:04:55 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0921257
Page 82 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, 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-12-2021 15:51:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Feb-12-2021 13:59:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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-12-2021 10:14:33 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Nov-06-2020 13:17:01 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0921258
Page 83 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921259
Page 84 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-14-2020 16:44:08
(UTC-05:00) Eastern
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
Sep-14-2020 16:44:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921260
Page 85 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-14-2020 16:44:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/14/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921261
Page 86 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-14-2020 16:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10901384Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-14-2020 16:43:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-14-2020 16:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-14-2020 16:44:39
(UTC-05:00) Eastern
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
Sep-14-2020 16:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921262
Page 87 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-14-2020 16:44:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921263
Page 88 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-14-2020 16:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-14-2020 16:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-14-2020 16:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921264
Page 89 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-14-2020 16:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Penicillin All
ergy
Start Date: UNK/UNK/1
985
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-14-2020 16:45:53
(UTC-05:00) Eastern
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
Sep-14-2020 16:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Penicillin AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-14-2020 16:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-14-2020 16:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921265
Page 90 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b
Date Location User Value Reason
Sep-14-2020 16:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Allergic Rhin
itis
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-14-2020 16:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 16:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic RhinitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-14-2020 16:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-14-2020 16:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921266
Page 91 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-14-2020 16:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:Stress Urinary In
continence
Start Date: UNK/UNK/2009
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-14-2020 16:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 16:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Stress Urinary IncontinenceInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-14-2020 16:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-14-2020 16:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-14-2020 16:47:23 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921267
Page 92 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Number
:4
Medical History T
erm:Acne
Start Date: UNK/UNK/1
994
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-14-2020 16:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 16:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AcneInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-14-2020 16:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-14-2020 16:47:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-14-2020 16:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921268
Page 93 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical History T
erm:Depression
Start Date: UNK/UNK/2
007
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-14-2020 16:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 16:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-14-2020 16:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-14-2020 16:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-14-2020 16:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Ear Tube Implan
tationInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921269
Page 94 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Start Date: UNK/UNK/198
1
Ongoing: NO
End Date:
UNK/UNK/1
983
1.f Line/MH Number:
Date Location User Value Reason
Sep-14-2020 16:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 16:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ear Tube ImplantationInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-14-2020 16:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1981Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-14-2020 16:49:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1983Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921270
Page 95 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
78.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
167.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.0Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921271
Page 96 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.6
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-14-2020 16:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921272
Page 97 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921273
Page 98 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-14-2020 16:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921274
Page 99 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-14-2020 17:20:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-14-2020 17:20:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
89539Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921275
Page 100 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 16:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 16:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 16:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 16:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 16:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 16:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB7PJInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921276
Page 101 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 16:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB7PJInitial Entry
5.b
Date Location User Value Reason
Sep-14-2020 16:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB7PKInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-14-2020 16:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB7PKInitial Entry
5.c
Date Location User Value Reason
Sep-14-2020 16:47:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8F7CInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921277
Page 102 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User ValueReason
Sep-16-2020
04:09:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-15-2020
16:20:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Sep-15-2020
04:05:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4695722;The
barcode BP8F7C is
recorded for two
subjects 10901384
and 10901385. Two
different subjects can
not have same
Barcode. Please
review and update
the Barcode for either
subject.
Sep-14-2020
16:47:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
BP8F
7CInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0921278
Page 103 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 16:46:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 16:46:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 16:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 16:46:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 16:46:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 16:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8F7DInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921279
Page 104 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 16:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8F7DInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921280
Page 105 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 11:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921281
Page 106 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-14-2020 16:51:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921282
Page 107 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-14-2020 16:51:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921283
Page 108 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 09:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921284
Page 109 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 09:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020 09:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 09:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-07-2020 09:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-07-2020 09:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921285
Page 110 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 09:58:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921286
Page 111 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921287
Page 112 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-07-2020 09:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921288
Page 113 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 16:29:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 16:29:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 16:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 16:29:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-06-2020 16:29:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 16:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8FJPInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921289
Page 114 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 16:29:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8FJPInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921290
Page 115 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 11:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921291
Page 116 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-07-2020 10:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921292
Page 117 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 11:14:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921293
Page 118 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 09:29:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 09:29:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 09:29:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 09:29:42
(UTC-05:00) Eastern
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.
Nov-04-2020 09:29:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020 09:29:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCBFPInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921294
Page 119 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Nov-04-2020 09:29:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCBFPInitial Entry
5.b
Date Location User Value Reason
Nov-04-2020 09:30:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSN4LVInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-04-2020 09:30:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSN4LVInitial Entry
5.c
Date Location User Value Reason
Nov-04-2020 09:30:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSN4LTInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-04-2020 09:30:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSN4LTInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921295
Page 120 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-03-2020 11:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020 11:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020 11:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921296
Page 121 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921297
Page 122 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
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
Mar-12-2021 16:32:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered frozen
Mar-12-2021 16:32:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered please unfreeze
Mar-12-2021 15:33:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - thank you.
Then please
harmonize event term
on AE CRF (still cyst)
by updating to SAE
event term of 'Rt
ovarian Torsion'
Mar-12-2021 11:05:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened SAE RECON:
AER#2021148721,the
term was updated to
'right ovarian torsion'
in Safety database
while recorded as
'hemorrhagic cyst on
Right ovary' in AE
CRF. Please confirm
correct term.If safety
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921298
Page 123 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
update is required,
please submit a
follow-up form.
Mar-12-2021 07:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered NO. the new term T
ovarian torsion is
correct , the only term
and is replacing the
prior term the pt used
to report.
Mar-11-2021 22:31:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - sorry, to
clarify: you are
changing the SAE
report event term back
from 'Rt ovarian
torsion' to the original
'hemorrhagic cyst on
Rt ovary'?
Mar-11-2021 12:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered AE term was updated
after receiving med
records, SAE update
will be faxed to
confirm
Mar-11-2021 12:18:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Event term is
hemorrhagic cyst Rt.
ovary; however, SAE
event term is Rt.
Ovarian Torsion.
Please review,
harmonize reporting,
and update where
appropriate
Mar-03-2021 14:34:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for requested
clinical symptoms
information
Mar-01-2021 13:20:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered awaiting medical
records and will fax
update
Mar-01-2021 11:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - please
submit a SAE safety
update stating the sign
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921299
Page 124 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
or symptom that
prompted the
performance of an abd
US on 07Dec20
(when cyst was
discovered)
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hemorrhagic cyst on Right ov
aryInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-01-2021 11:14:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-01-2021 11:14:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-01-2021 11:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Event start
date 10Dec20;
however US ordered
07Dec20 & showed
cyst. In Vaccine
study, SAE start date
is day event starts;
not day it meets
serious criteria (item
11 in vaccine SAE
instruct). If
symptoms on 07Dec,
please update Start
date (AE/SAE)
Mar-01-2021 09:20:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020 UNK:UNKNew Information
Mar-01-2021 09:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Follow up AEM
form was submitted
on 2/23/21, as per
query onset date in
vaccine studies
should not be start
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0921300
Page 125 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
date of SAE, but start
date of event
Feb-24-2021 01:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021148721
onset date was
10Dec2020 in Safety
database however,
updated to
07Dec2020 on AE
CRF. Please confirm
if a follow up AEM
form was submitted
to update onset date
in Safety database.
Feb-16-2021 17:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-16-2021 17:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020 18:30New Information
Feb-16-2021 15:32:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Event start
date 10Dec20;
however US ordered
07Dec20 & showed
cyst. In Vaccine
study, SAE start date
is day event starts;
not day it meets
serious criteria (item
11 in vaccine SAE
instruct). If
symptoms on 07Dec,
please update Start
date (AE/SAE)
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/10/2020 18:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0921301
Page 126 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/12/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-15-2021 15:32:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-01-2021 10:59:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for requested
COVID test
information.
Feb-18-2021 13:22:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered awaiting
information
Feb-16-2021 15:34:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID test
status (yes/no)
during
Hosp/Surgery was
not reported in the
SAE. Please submit
a follow-up SAE
form [#2021148721]
to document if
COVID testing was
performed
(YES/NO or info
not available) and if
yes, the date and
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921302
Page 127 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
results.
Feb-16-2021 03:34:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE hemorrhagic
cyst on Right ovary:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
YES
Other medically important ser
ious eventInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0921303
Page 128 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
unkInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921304
Page 129 of 146
***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, Answered Queries, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-15-2021 15:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-16-2021 03:34:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021148721Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921305
Page 130 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-03-2020 11:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921306
Page 131 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-03-2020 11:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-03-2020 11:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-03-2020 11:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route,
use, formulation).
Date Location User Value Reason
Nov-03-2020 11:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Flu vaccineInitial Entry
5. Date:
Date Location User Value Reason
Nov-03-2020 11:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921307
Page 132 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021 10:14:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921308
Page 133 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
- eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-12-2021 10:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/11/2021Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921309
Page 134 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 15:51:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 15:51:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 15:51:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 15:51:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/11/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8GCCInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921310
Page 135 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Feb-12-2021 15:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8GCCInitial Entry
5.b
Date Location User Value Reason
Feb-12-2021 15:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS1D84Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-12-2021 15:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS1D84Initial Entry
5.c
Date Location User Value Reason
Feb-12-2021 15:52:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS1D83Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-12-2021 15:52:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS1D83Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921311
Page 136 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 15:51:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 15:51:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 15:51:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 15:51:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-12-2021 15:51:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/11/2021Initial Entry
5.a
Date Location User Value Reason
Feb-12-2021 15:51:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8GCJInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921312
Page 137 of 146
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Feb-12-2021 15:51:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8GCJInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921313
Page 138 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/25/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 07:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-05-2021 12:31:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Source is uploaded
Mar-03-2021 23:48:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Please upload
source documents
in Florence.
Feb-25-2021 16:20:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-25-2021 16:20:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0921314
Page 139 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/25/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-28-2021 20:51:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-28-2021 20:51:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-28-2021 20:51:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-28-2021 20:51:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-28-2021 20:51:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-28-2021 20:51:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BV0FD9Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921315
Page 140 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/25/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Feb-28-2021 20:51:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BV0FD9Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921316
Page 141 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/11/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021 15:15:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/11/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-11-2021 15:15:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SSWAB_WEEK4Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921317
Page 142 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-11-2021 16:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021 16:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021 16:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-11-2021 16:42:22
(UTC-05:00) Eastern
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.
Mar-11-2021 16:42:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021 16:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTWT76Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921318
Page 143 of 146
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Sample ID
Date Location User Value Reason
Mar-11-2021 16:42:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTWT76Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0921319
Page 144 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-03-2020 11:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-14-2020 17:20:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-14-2020 16:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-03-2021 08:25:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-02-2021 07:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered will be updated as per
query
Feb-15-2021 05:48:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021148721
hemorrhagic cyst on right
ovary(onset
date:20Dec2020)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Nov-03-2020 11:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/3/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0921320
Page 145 of 146
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-14-2020 17:20:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/14/2020Initial Entry
Sep-14-2020 16:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/14/2020Initial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0921321
Page 146 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901384 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 13:16:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
HongData Entry:
Click Here to EnableInitial Entry
090177e196ae3d81\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0921322