Document text
Page 1 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900787
Page 2 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900788
Page 3 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10271105]
2.Birth Date: /1974
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900789
Page 4 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900790
Page 5 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900791
Page 6 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900792
Page 7 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Shellfish]
Start Date: UNK/UNK/1996
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Iodine]
Start Date: UNK/UNK/1996
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraine Headaches]
Start Date: UNK/UNK/1995
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mitral Valve Prolapse]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900793
Page 8 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [144.0]
3.Unit: LB
4.Height: [64.75]
5.Unit: in
6.Body Mass Index: [24.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900794
Page 9 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900795
Page 10 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [72609]
3.Randomization Group: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900796
Page 11 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN60VJ]
5.bSample ID [BN60VK]
5.cSample ID [BN60VL]
5.dSample ID [BLBB1F]
5.eSample ID [BLBB1G]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900797
Page 12 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN60ZF]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900798
Page 13 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 15:00
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
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900799
Page 14 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900800
Page 15 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900801
Page 16 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900802
Page 17 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
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:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900803
Page 18 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BN615S]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900804
Page 19 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/17/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
RECENT SYSTEMIC CORTICOSTEROID TREATMENTComments
2.Treatment Name [ ] Comments
3.Formulation: Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Comments
6.Body Side: Not Done Comments
7.Route: Comments
8.Actual Dose: [ ] Comments
9.Unit: Comments
10.Timeframe Subject Was Observed Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900805
Page 20 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900806
Page 21 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Samples were drawn under the Convalescent COVID A1 visit. Visit 3 and
Convalescent COVID A1 were combined and completed together.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900807
Page 22 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900808
Page 23 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900809
Page 24 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900810
Page 25 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900811
Page 26 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900812
Page 27 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900813
Page 28 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900814
Page 29 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/12/2020
2.Date of First Symptom Started: Sep/11/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/14/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900815
Page 30 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900816
Page 31 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900817
Page 32 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[No sample was collected. Cough was related to GERD.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900818
Page 33 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[No sample was collected. Cough was related to GERD.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900819
Page 34 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900820
Page 35 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900821
Page 36 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900822
Page 37 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900823
Page 38 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900824
Page 39 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900825
Page 40 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900826
Page 41 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900827
Page 42 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900828
Page 43 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900829
Page 44 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900830
Page 45 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900831
Page 46 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900832
Page 47 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900833
Page 48 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900834
Page 49 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900835
Page 50 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900836
Page 51 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900837
Page 52 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900838
Page 53 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900839
Page 54 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/20/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900840
Page 55 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Convalescent COVID A1 Visit and Visit 3 were combined together. Labs for both
visits are listed below.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP29SK]
5.bSample ID [BLB9KC]
5.cSample ID [BLC1P9]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900841
Page 56 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900842
Page 57 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900843
Page 58 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/11/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [Subject has discontinued Study Drug. Subject has agreed to continue with follow-up
visits.]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900844
Page 59 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900845
Page 60 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900846
Page 61 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900847
Page 62 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
1. ADVERSE
EVENT 1 Allergic Reaction to investi
gational product Aug/29/2020 U
NK:UNK NO
End Date Time:
Sep/11/2020 UNK:U
NK
Repeating
Pages
2. ADVERSE
EVENT 2 Left-sided chest pain Sep/8/2020 UN
K:UNK NO
End Date Time:
Sep/8/2020 UNK:U
NK
Repeating
Pages
3. ADVERSE
EVENT 3 Lower back pain Sep/8/2020 UN
K:UNK NO
End Date Time:
Sep/11/2020 UNK:U
NK
Repeating
Pages
4. DELETED ADVERSE
EVENT 4 Cough Sep/11/2020 U
NK:UNK NO
End Date Time:
Sep/14/2020 UNK:U
NK
Repeating
Pages
5. ADVERSE
EVENT 5 Mid back pain Sep/11/2020 U
NK:UNK NO
End Date Time:
Sep/14/2020 UNK:U
NK
Repeating
Pages
6. ADVERSE
EVENT 6 Right leg weakness Sep/10/2020 U
NK:UNK NO
End Date Time:
Sep/10/2020 UNK:U
NK
Repeating
Pages
7. ADVERSE
EVENT 7 Right arm numbness Sep/11/2020 U
NK:UNK NO
End Date Time:
Sep/11/2020 UNK:U
NK
Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900848
Page 63 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
8. ADVERSE
EVENT 8 GERD Sep/8/2020 UN
K:UNK YES Repeating
Pages
9. ADVERSE
EVENT 9 Throat Swelling Aug/29/2020 U
NK:UNK NO
End Date Time:
Sep/8/2020 UNK:U
NK
Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900849
Page 64 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Allergic Reaction to investigational product]
4.Start Date Time: Aug/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900850
Page 65 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900851
Page 66 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left-sided chest pain]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Gerd]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900852
Page 67 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900853
Page 68 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Lower back pain]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[GERD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900854
Page 69 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900855
Page 70 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cough]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[GERD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900856
Page 71 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900857
Page 72 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mid back pain]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[GERD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900858
Page 73 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900859
Page 74 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right leg weakness]
4.Start Date Time: Sep/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900860
Page 75 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900861
Page 76 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right arm numbness]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/11/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900862
Page 77 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900863
Page 78 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[GERD]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[acid reflux]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900864
Page 79 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900865
Page 80 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Throat Swelling]
4.Start Date Time: Aug/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900866
Page 81 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900867
Page 82 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900868
Page 83 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900869
Page 84 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. DELETED 1 VACCINATIONS
NO Prednisone Sep/2/2
020 Repeating
Pages
2. DELETED 2 VACCINATIONS
NO Solumedrol Sep/2/2
020 Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900870
Page 85 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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).[Prednisone ]
5.Date: Sep/2/2020
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900871
Page 86 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
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).[Solumedrol ]
5.Date: Sep/2/2020
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900872
Page 87 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. DELETED 1 CORTICOSTER
OIDS NO Prednisone 30 Repeating
Pages
2. DELETED 2 CORTICOSTER
OIDS NO Solumedrol 80 Repeating
Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900873
Page 88 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
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).[Prednisone ]
5.Dose: [30]
6.Dose Unit: mg
7.Dose Frequency: UNKNOWN
8.Route: ORAL
9.Start Date: Sep/2/2020
10.Ongoing? NO
End Date:
Sep/4/2020
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900874
Page 89 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: CORTICOSTEROIDS
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).[Solumedrol ]
5.Dose: [80]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAMUSCULAR
9.Start Date: Sep/7/2020
10.Ongoing? NO
End Date:
Sep/7/2020
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900875
Page 90 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900876
Page 91 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900877
Page 92 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900878
Page 93 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900879
Page 94 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900880
Page 95 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900881
Page 96 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900882
Page 97 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900883
Page 98 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900884
Page 99 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900885
Page 100 of 277
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900886
Page 101 of 277
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900887
Page 102 of 277
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900888
Page 103 of 277
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900889
Page 104 of 277
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900890
Page 105 of 277
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900891
Page 106 of 277
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900892
Page 107 of 277
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900893
Page 108 of 277
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900894
Page 109 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/11/2020
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900895
Page 110 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900896
Page 111 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Dec-16-2020 09:08:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900897
Page 112 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-28-2020 16:22:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900898
Page 113 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900899
Page 114 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900900
Page 115 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900901
Page 116 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900902
Page 117 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-22-2020 07:24:01 (UTC-05:00) Eastern Time
(US & Canada)Subject discontinued study drug due to AE # 1.
Not Done
4Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
4Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
4Sep-18-2020 08:10:54 (UTC-05:00) Eastern Time
(US & Canada)Did not receive vaccine #2 due to reaction (throat
itching, difficulty swallowing, and "lump in throat")
after vaccine #1, was treated with systemic and oral
steroids, and eventually an endoscopy was
performed (normal). Agrees to stay in study w/o V
#2.
Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900903
Page 118 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
5Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900904
Page 119 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Sep-22-2020 07:24:27 (UTC-05:00) Eastern Time
(US & Canada)Vaccination 2 was not given.
Not Done
6Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
6Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
6Sep-18-2020 08:11:06 (UTC-05:00) Eastern Time
(US & Canada)Did not receive vaccine #2 due to reaction (throat
itching, difficulty swallowing, and "lump in throat")
after vaccine #1, was treated with systemic and oral
steroids, and eventually an endoscopy was
performed (normal). Agrees to stay in study w/o V
#2.
Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900905
Page 120 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
7Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900906
Page 121 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
8Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900907
Page 122 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
9Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada) )Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900908
Page 123 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
10Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
10Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada) )Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900909
Page 124 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
11Sep-22-2020 07:24:43 (UTC-05:00) Eastern Time
(US & Canada)Vaccination 2 was not given.
Not Done
11Sep-22-2020 07:21:40 (UTC-05:00) Eastern Time
(US & Canada)
11Sep-21-2020 15:34:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
11Sep-18-2020 08:11:16 (UTC-05:00) Eastern Time
(US & Canada) )Did not receive vaccine #2 due to reaction (throat
itching, difficulty swallowing, and "lump in throat")
after vaccine #1, was treated with systemic and oral
steroids, and eventually an endoscopy was
performed (normal). Agrees to stay in study w/o V
#2.
Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900910
Page 125 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900911
Page 126 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900912
Page 127 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900913
Page 128 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900914
Page 129 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900915
Page 130 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900916
Page 131 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900917
Page 132 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900918
Page 133 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900919
Page 134 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Oct-12-2020 09:26:09 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900920
Page 135 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-22-2020 07:16:59 (UTC-05:00) Eastern Time
(US & Canada) )Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900921
Page 136 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-22-2020 07:16:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900922
Page 137 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-22-2020 07:16:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900923
Page 138 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-22-2020 07:16:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900924
Page 139 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-22-2020 07:16:59 (UTC-05:00) Eastern Time
(US & Canada) )Not Applicable
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900925
Page 140 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Dec-16-2020 09:08:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-15-2020 12:16:12 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-12-2020 14:01:25 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-12-2020 08:29:26 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-28-2020 09:07:50 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900926
Page 141 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-27-2020 16:18:24 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-27-2020 11:31:59 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900927
Page 142 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 16:21:27
(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
Aug-28-2020 16:21:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900928
Page 143 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 16:21:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900929
Page 144 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 16:21:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10271105Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 16:21:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 16:21:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 16:21:58
(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
Aug-28-2020 16:21:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERICANInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0900930
Page 145 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 16:22:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900931
Page 146 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 16:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 16:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 16:22:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900932
Page 147 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 16:26:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Allergy to Shellf
ish
Start Date: UNK/UNK/199
6
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:26:40
(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
Aug-28-2020 16:26:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to ShellfishInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 16:26:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 16:26:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020 16:27:13 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900933
Page 148 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:Allergy to Iodi
ne
Start Date: UNK/UNK/19
96
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:27:13
(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
Aug-28-2020 16:27:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to IodineInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 16:27:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 16:27:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-28-2020 16:28:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900934
Page 149 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:28:29
(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
Aug-28-2020 16:28:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 16:28:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 16:28:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-28-2020 16:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Migraine Headac
hes
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900935
Page 150 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:28:58
(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
Aug-28-2020 16:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Migraine HeadachesInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 16:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 16:28:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-28-2020 16:29:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Mitral Valve Prol
apse
Start Date: UNK/UNK/2007
Ongoing: YESInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900936
Page 151 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:29:29
(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
Aug-28-2020 16:29:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mitral Valve ProlapseInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 16:29:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 16:29:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900937
Page 152 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000
)Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 16:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 144 is outside
of Normal Range 25 -
136 for kg or 50 -
300 for lb.
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
144.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 16:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 16:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBTranscription Error
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened kg is selected for
weight unit, then cm
is expected to be
selected for Height
unit. Please check and
update data as
appropriate.
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900938
Page 153 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
64.75Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 16:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.1Transcription Error
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Location
::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900939
Page 154 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Unit:
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 16:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900940
Page 155 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900941
Page 156 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 16:31:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900942
Page 157 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 16:31:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 16:31:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
72609Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900943
Page 158 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 16:23:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 16:23:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 16:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 16:23:44
(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.
Aug-28-2020 16:23:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 16:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN60VJInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 16:23:53 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0900944
Page 159 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)BN60VJ
5.b
Date Location User Value Reason
Aug-28-2020 16:23:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN60VKInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 16:23:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN60VKInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 16:24:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN60VLInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 16:24:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN60VLInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 16:24:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBB1FInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 16:24:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLBB1FInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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) (4),
(b) (6)
FDA-CBER-2021-5683-0900945
Page 160 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e
Date Location User Value Reason
Aug-28-2020 16:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBB1GInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 16:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLBB1GInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900946
Page 161 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 16:24:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 16:24:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 16:24:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 16:24:39
(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.
Aug-28-2020 16:24:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 16:24:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN60ZFInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 16:24:48 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900947
Page 162 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)BN60ZF
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900948
Page 163 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 15:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900949
Page 164 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-28-2020 16:33:26
(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
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-28-2020 16:33:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900950
Page 165 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 16:33:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUB
JECTInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900951
Page 166 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 08:00:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900952
Page 167 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 08:01:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 08:01:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 08:01:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 08:01:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 08:01:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 08:01:15
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900953
Page 168 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900954
Page 169 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 08:01:37
(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-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 08:01:37
(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-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900955
Page 170 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 08:01:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900956
Page 171 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 08:01:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 08:01:57
(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-18-2020 08:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 08:01:57
(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-18-2020 08:01:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 08:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN615SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 08:02:05 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900957
Page 172 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)BN615S
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900958
Page 173 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
15:11:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Clo
sedAuto closed by
Validation Check:
VC_EC001_2_13
Sep-22-2020
15:01:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clo
sedResponse satisfies
query
Sep-22-2020
07:22:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: An
sweredInitial Entry
Sep-22-2020
07:22:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredInitial Entry
Sep-22-2020
07:22:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Fir
st Delay:
Sep/17/2
020
Reason(s) f
or Tempora
ry Delay of
Vaccinatio
n
FEVER
OR ACU
TE ILLN
ESS
RECENT
SYSTEM
IC CORTInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900959
Page 174 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ICOSTE
ROID TR
EATME
NT
Sep-22-2020
07:21:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-22-2020
03:33:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Op
enedDMW4767400;Temp
Delay is not expected
to be Unknown or
Not Applicable.
Please review and
update appropriately
or clarify
Sep-22-2020
02:41:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Rei
ssued:Opene
dGPDCLIN: Please
record the systemic
steroids therapy on
the prohibited
concomitant
medication log page.
Sep-21-2020
15:34:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not Applica
bleInitial Entry
Sep-21-2020
15:34:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: An
sweredChanged Information
Sep-21-2020
15:34:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Sep-21-2020
13:59:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Op
enedGPDCLIN: Please
record the systemic
steroids therapy on
the prohibited
concomitant
medication log page.
Please also clarify
why temporary delay
of second vaccination
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900960
Page 175 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
is listed if AE of
allergic reaction is
listed with action
taken of drug
withdrawn.
Sep-18-2020
08:02:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Fir
st Delay:
Sep/17/2
020
Reason(s) f
or Tempora
ry Delay of
Vaccinatio
n
FEVER
OR ACU
TE ILLN
ESS
RECENT
SYSTEM
IC CORT
ICOSTE
ROID TR
EATME
NTInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900961
Page 176 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020
04:40:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Del
etedQuery is invalid or does not
apply
Sep-22-2020
15:11:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_EC001_2_06_AN
Sep-22-2020
07:24:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
Not D
oneInitial Entry
Sep-22-2020
07:21:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:Initial Entry
Sep-21-2020
07:20:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredSubject was not administered
Vaccination 2.
Sep-21-2020
03:25:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Can
didateDMW4747292;Dose Date is
not expected to be Unknown
or Not Applicable. Please
review and update
appropriately or clarify
Sep-18-2020
14:53:24
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW4747324;Randomization
number is recorded and the
final disposition date is
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900962
Page 177 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time
(US &
Canada)present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Sep-18-2020
08:10:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
Not A
pplica
bleInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020 07:24:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-18-2020 08:11:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900963
Page 178 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Unit:
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-21-2020 15:34:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-22-2020 07:24:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Sep-22-2020 07:21:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-18-2020 08:11:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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)
FDA-CBER-2021-5683-0900964
Page 179 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-24-2020
03:44:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Oct-23-2020
07:58:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredVisit 3 and COVID_A1 Visit
occurred on the same day.
They occurred back-to-back.
Oct-23-2020
02:25:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW5086922;The Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L
is the same as the other Date
of Visit at Visit COVID_A1.
Please review for duplication
and update as appropriate.
Oct-20-2020
15:03:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/20
/2020Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900965
Page 180 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 15:05:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 15:05:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 07:26:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-21-2020 07:26:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOChanged Information
Oct-21-2020 06:34:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-20-2020 15:05:09
(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-20-2020 15:05:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900966
Page 181 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-20-2020 15:05:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Samples were drawn under the Conval
escent COVID A1 visit. Visit 3 and Co
nvalescent COVID A1 were combined
and completed together.Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900967
Page 182 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 01:12:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site
confirmation - updated
PD tracker
Oct-13-2020 07:26:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Nasal swab was not
collected for the
Potential Illness.
Oct-13-2020 04:32:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ : Details for
either Nasal Swab Self
or Nasal Swab
expected to be
completed. Please
check and update else
clarify.
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-12-2020 09:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Oct-12-2020 09:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Oct-12-2020 09:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900968
Page 183 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020 09:24:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0900969
Page 184 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Sep/14/2020Initial Entry
4.a
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900970
Page 185 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.b
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900971
Page 186 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900972
Page 187 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900973
Page 188 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.h
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-12-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900974
Page 189 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900975
Page 190 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-12-2020 09:26:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900976
Page 191 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 09:27:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 09:27:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 09:27:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-12-2020 09:30:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-12-2020 09:30:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
No sample was collected. Cough was r
elated to GERD.Transcription Error
Oct-12-2020 09:27:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text has either
a carriage return (line
break) or extra spaces
at the end of the text
or between words.
Please correct by
removing all data in
the field and re-enter
without adding extra
spaces or using enter
or tab keys.
Oct-12-2020 09:27:28 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900977
Page 192 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)No sample was collected. Cough was r
elated to GERD.
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900978
Page 193 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 09:27:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 09:27:42
(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-12-2020 09:27:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-12-2020 09:27:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
No sample was collected. Cough was r
elated to GERD.Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900979
Page 194 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or C
ontacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900980
Page 195 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:PRIMARY CAR
E PHYSICIAN
Occurrence of Vis
its or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT C
ARE
Occurrence of Visits or
Contacts:NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900981
Page 196 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:TELEPHONE C
ONSULTATION
Occurrence of Vis
its or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Cont
acts:NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900982
Page 197 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-12-2020 09:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900983
Page 198 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-12-2020 09:28:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-12-2020 09:28:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020 09:28:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900984
Page 199 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/20/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-24-2020
03:37:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Oct-23-2020
07:57:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredVisit 3 and COVID_A1 Visit
occurred on the same day. They
occurred back-to-back.
Oct-23-2020
02:25:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5086921;The Date of
Visit at Visit COVID_A1 is the
same as the other Date of Visit
at Visit
V3_MONTH1_POSTVAX2_L.
Please review for duplication
and update as appropriate.
Oct-20-2020
14:50:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/2
0/202
0Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-20-2020 14:50:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900985
Page 200 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 15:33:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 15:33:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 15:33:54
(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-20-2020 15:33:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-20-2020 15:38:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Convalescent COVID A1 Visit and Vis
it 3 were combined together. Labs for b
oth visits are listed below.Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900986
Page 201 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/20/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-20-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP29SKInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 15:34:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP29SKInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 15:34:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB9KCInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 15:34:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLB9KCInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 15:34:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLC1P9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 15:34:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLC1P9Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900987
Page 202 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-13-2020 05:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-12-2020 08:30:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-12-2020 08:30:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Changed Information
Nov-10-2020 21:26:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened The discontinuation
date of 17SEP2020
should be relative to
the AE causing the the
withdrawal of the
study vaccine, AE
start 29AUG2020 and
end 08SEP2020.
Please adjust
Discontinuation date.
Sep-22-2020 07:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-22-2020 07:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 00:42:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 3: Closed Response satisfies
query
Oct-27-2020 16:19:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered The subject
discontinued Study
drug. The subject
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900988
Page 203 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
agreed to continue
with follow-up visits.
Oct-27-2020 16:18:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-23-2020 10:24:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-22-2020 13:51:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto Query
Sep-22-2020 11:43:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened There is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
AE#1 and correct the
data.
Sep-22-2020 11:41:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-22-2020 07:21:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered AE#1 caused the
subject to discontinue
study treatment.
Subject will continue
with follow-up visits.
Sep-22-2020 07:20:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered AE #1 caused the
subject to discontinue
study treatment.
Subject agreed to
continue with
follow-up visits.
Sep-22-2020 07:15:56
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900989
Page 204 of 277
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-22-2020 07:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Sep-22-2020 07:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-22-2020 07:15:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject has discontinued Study Drug.
Subject has agreed to continue with fol
low-up visits.Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900990
Page 205 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-23-2020
21:35:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Clo
sedResponse satisfies
query
Sep-23-2020
10:29:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Clo
sedResponse satisfies
query
Sep-23-2020
07:07:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ans
weredThe subject
discontinued study
drug but agreed to
complete study
visits. Is this page
applicable? EOT
page is completed.
Sep-23-2020
02:10:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 2: Ope
nedDMW4777443;Date
is not expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Sep-22-2020
07:16:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not Applicab
leInitial Entry
Sep-22-2020
07:16:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription Error
Sep-22-2020
07:16:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0900991
Page 206 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-21-2020
22:08:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Ope
nedClinQuery: As
subject has
discontinued study
drug but agreed to
continue with
follow-up visits,
EOT CRF page
should be completed
with reason for IP
discontinuation,
instead of FUP.
Sep-18-2020
08:58:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-22-2020 07:16:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-22-2020 07:16:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Sep-18-2020 08:58:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 10:26:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-22-2020 13:52:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered AE page has been
updated.
Sep-22-2020 11:48:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900992
Page 207 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-22-2020 11:47:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened We understand that
the subject
discontinued study
drug and will
continue with follow
up, but there is no
Adverse Event with
'Did the adverse event
cause the subject to
be discontinued from
the study' reported as
YES. Please update
AE page accordingly.
Sep-22-2020 11:39:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Sep-22-2020 11:38:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 6: Closed Response satisfies
query
Sep-22-2020 07:16:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-22-2020 07:16:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-21-2020 15:47:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 6: Answered Subject was
discontinued from
study medication but
will continue to
complete follow-up
visits.
Sep-21-2020 15:44:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 6: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-21-2020 07:21:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 5: Answered Subject was
discontinued from
study drug but will
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900993
Page 208 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
continue with
follow-up visits.
Sep-21-2020 07:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-21-2020 07:15:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered The subject
discontinued study
drug but will continue
with follow-up visits.
Sep-21-2020 07:14:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answered AE # 1 - Allergic
Reaction caused the
subject to be
discontinue study
drug.
Sep-20-2020 09:15:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened DM 1: Response to
"Status" is
ADVERSE EVENT
but "Specify Status"
is Provided. Please
check and update
accordingly.
Sep-20-2020 09:05:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Duplicate query
(re-issued).
Sep-20-2020 09:04:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Duplicate query.
Sep-20-2020 09:04:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM 1: As per
response AE page
updated, but there is
no Adverse Event
with 'Did the adverse
event cause the
subject to be
discontinued from the
study' reported as
YES. Please recheck
and update AE page
accordingly, else
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0900994
Page 209 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
clarify.
Sep-18-2020 12:53:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Answered Original value is
correct
Sep-18-2020 12:53:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Sep-18-2020 12:48:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered The subject
discontinued study
drug but will continue
to come into site for
follow-up visits.
Sep-18-2020 12:31:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-18-2020 09:18:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is
correct
Sep-18-2020 09:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered AE page updated.
Sep-18-2020 08:58:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Sep-18-2020 08:58:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-18-2020 08:58:09 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0900995
Page 210 of 277
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)ADVERSE EVENT
4. Specify Status:
Date Location User Value Reason
Sep-22-2020 07:16:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-22-2020 07:16:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-18-2020 12:53:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject has discontinued Study Drug.
Subject will continue with follow-up v
isits.Changed Information
Sep-18-2020 08:58:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject has discontinued Study Drug.
Subject remains in Follow-up.Initial Entry
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0900996
Page 211 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-18-2020 09:16:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e12\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0900997
Page 212 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271105 Subject
…[truncated]