Document text
Page 1 of 164
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969917
Page 2 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969918
Page 3 of 164
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10941155]
2.Birth Date: /1993
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0969919
Page 4 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969920
Page 5 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969921
Page 6 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969922
Page 7 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Type II]
Start Date: UNK/UNK/2011
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal allergies]
Start Date: UNK/UNK/1995
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969923
Page 8 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eczema]
Start Date: UNK/UNK/1995
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal hernia]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal hernia repair]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[wisdom teeth removal]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969924
Page 9 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969925
Page 10 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [90.9]
3.Unit: kg
4.Height: [182.8]
5.Unit: cm
6.Body Mass Index: [27.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969926
Page 11 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [92715]
3.Randomization Group: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969927
Page 12 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BN6C63]
5.bSample ID [BN6C64]
5.cSample ID [BL9Y5N]
5.dSample ID [BL9Y5P]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969928
Page 13 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BN6C6C]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969929
Page 14 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 11:21
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
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969930
Page 15 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969931
Page 16 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969932
Page 17 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969933
Page 18 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BP1M8D]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969934
Page 19 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: Nov/10/2020 11:21
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
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969935
Page 20 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969936
Page 21 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/8/2020
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 [BP1LN8]
5.bSample ID [BP1LN9]
5.cSample ID [BKBHWY]
5.dSample ID [BKBHWZ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969937
Page 22 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969938
Page 23 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969939
Page 24 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969940
Page 25 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969941
Page 26 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969942
Page 27 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969943
Page 28 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969944
Page 29 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969945
Page 30 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969946
Page 31 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969947
Page 32 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969948
Page 33 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969949
Page 34 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 colon injury Oct/16/2020 UNK:
UNK NO
End Date Time:
Oct/23/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 motor vehicle acc
ident Oct/16/2020 UNK:
UNK NO
End Date Time:
Oct/16/2020 UNK:UNK
Repeating
Pages
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969950
Page 35 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[colon injury]
4.Start Date Time: Oct/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/23/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969951
Page 36 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[Motor vehicle accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020411870]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969952
Page 37 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[motor vehicle accident]
4.Start Date Time: Oct/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/16/2020 UNK:UNK
6.Toxicity Grade: 3
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:
[driving accident]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969953
Page 38 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969954
Page 39 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969955
Page 40 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969956
Page 41 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969957
Page 42 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969958
Page 43 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969959
Page 44 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969960
Page 45 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969961
Page 46 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969962
Page 47 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969963
Page 48 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969964
Page 49 of 164
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969965
Page 50 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969966
Page 51 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969967
Page 52 of 164
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969968
Page 53 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969969
Page 54 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969970
Page 55 of 164
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969971
Page 56 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969972
Page 57 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969973
Page 58 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969974
Page 59 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969975
Page 60 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969976
Page 61 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969977
Page 62 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/27/2021
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969978
Page 63 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969979
Page 64 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969980
Page 65 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1LWD]
5.bSample ID [BP1LWF]
5.cSample ID [BLBV4S]
5.dSample ID [BLBV4T]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969981
Page 66 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1LXP]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969982
Page 67 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/27/2021 15:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969983
Page 68 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969984
Page 69 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTV25J]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969985
Page 70 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 09:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969986
Page 71 of 164
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/19/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969987
Page 72 of 164
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969988
Page 73 of 164
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969989
Page 74 of 164
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969990
Page 75 of 164
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969991
Page 76 of 164
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969992
Page 77 of 164
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969993
Page 78 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/8/2020
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969994
Page 79 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969995
Page 80 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969996
Page 81 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-28-2020 12:46:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969997
Page 82 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-03-2021 00:15:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969998
Page 83 of 164
***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, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Dec-16-2020 00:49:17 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Murtaza
Mussaji Approved Nov-17-2020 08:35:04 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MurtazaMussaji, 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.
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0969999
Page 84 of 164
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-28-2020 12:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020 12:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970000
Page 85 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020 12:46:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970001
Page 86 of 164
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-28-2020 12:45:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10941155Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-28-2020 12:45:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1993Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020 12:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-28-2020 12:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-28-2020 12:46:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970002
Page 87 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 12:46:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970003
Page 88 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-28-2020 12:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 12:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 12:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970004
Page 89 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020 12:48:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Asthma
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:48:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:48:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-28-2020 12:48:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-28-2020 12:48:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970005
Page 90 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.b
Date Location User Value Reason
Sep-28-2020 12:48:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Diabetes Typ
e II
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:48:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:48:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Diabetes Type IIInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-28-2020 12:48:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-28-2020 12:48:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970006
Page 91 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-28-2020 12:48:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Seasonal aller
gies
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:48:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:48:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal allergiesInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-28-2020 12:48:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-28-2020 12:48:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-28-2020 12:49:08
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number 4Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970007
Page 92 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) :
Medical History T
erm:Anxiety
Start Date: UNK/UNK/2
019
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-28-2020 12:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-28-2020 12:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-28-2020 12:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970008
Page 93 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Medical History T
erm:Eczema
Start Date: UNK/UNK/1
995
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EczemaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-28-2020 12:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-28-2020 12:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-28-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Inguinal herniaInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970009
Page 94 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/
1998
1.f Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inguinal herniaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-28-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-28-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.g
Date Location User Value Reason
Sep-28-2020 12:50:08
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970010
Page 95 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) Line/MH Numb
er:7
Medical History
Term:Inguinal hernia
repair
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/1
998
1.g Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inguinal hernia repairInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-28-2020 12:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-28-2020 12:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.h
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970011
Page 96 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-28-2020 12:51:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:wisdom teeth re
moval
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2013Transcription Error
Sep-28-2020 12:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:wisdom teeth re
moval
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2007Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970012
Page 97 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.h Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
wisdom teeth removalInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-28-2020 12:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-28-2020 12:51:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-28-2020 12:51:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Transcription Error
Sep-28-2020 12:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Term wisdom
teeth removal End
Date is prior to Start
Date.
Sep-28-2020 12:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970013
Page 98 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-28-2020 12:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970014
Page 99 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
90.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
182.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.2Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970015
Page 100 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.1
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 12:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970016
Page 101 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020 12:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020 12:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
92715Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970017
Page 102 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 12:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 12:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 11:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-29-2020 05:38:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 12:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 12:54:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970018
Page 103 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-29-2020 11:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6C63Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 11:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6C63Initial Entry
5.b
Date Location User Value Reason
Sep-29-2020 11:22:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6C64Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 11:22:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6C64Initial Entry
5.c
Date Location User Value Reason
Sep-29-2020 11:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9Y5NInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 11:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9Y5NInitial Entry
5.d
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970019
Page 104 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-29-2020 11:38:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9Y5PInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-29-2020 11:38:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9Y5PInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970020
Page 105 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 12:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 12:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-10-2020 00:39:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-29-2020 05:38:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 12:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 12:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970021
Page 106 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Oct-10-2020 00:39:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6C6CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-10-2020 00:39:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6C6CInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970022
Page 107 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 11:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970023
Page 108 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 12:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0970024
Page 109 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-28-2020 12:54:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970025
Page 110 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-17-2020
15:20:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedQuery will be
moved to the
SUBJECT STATUS
page.
Nov-17-2020
13:49:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedIllness eDiary:
Subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
21OCT2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Nov-12-2020
04:49:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedClosed per SITE
response, added to
PD tracker for
clinical review
Nov-11-2020
23:25:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
ddue to SAE #1
patient was unable
to conduct visit on
scheduled date. Visit
date is accurate
Nov-11-2020
15:24:02
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 23
days from
V1_DAY1_VAX1_L
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0970026
Page 111 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Canada) Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately.
Nov-10-2020
21:42:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Nov/1
0/202
0Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0970027
Page 112 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Nov-10-2020 21:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2.a
Date Location User Value Reason
Nov-10-2020 21:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-10-2020 21:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-10-2020 21:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-10-2020 21:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970028
Page 113 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Nov-10-2020 21:42:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970029
Page 114 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 21:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 21:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 08:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-11-2020 10:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-10-2020 21:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-10-2020 21:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0970030
Page 115 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a
Date Location User Value Reason
Nov-17-2020 08:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1M8DInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 08:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1M8DInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970031
Page 116 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020 11:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970032
Page 117 of 164
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-10-2020 21:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0970033
Page 118 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 00:49:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970034
Page 119 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 00:49:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 00:49:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 00:13:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-16-2020 05:38:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 00:49:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 00:49:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
5.a
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970035
Page 120 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Dec-17-2020 00:13:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1LN8Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 00:13:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1LN8Initial Entry
5.b
Date Location User Value Reason
Dec-17-2020 00:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1LN9Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 00:13:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1LN9Initial Entry
5.c
Date Location User Value Reason
Dec-17-2020 00:13:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKBHWYInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 00:13:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKBHWYInitial Entry
5.d
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970036
Page 121 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Dec-17-2020 00:13:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKBHWZInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-17-2020 00:13:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKBHWZInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970037
Page 122 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970038
Page 123 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970039
Page 124 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020
16:51:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Cl
osedResponse satisfies
query
Nov-16-2020
14:30:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: A
nsweredUpdated safety
report submitted
Nov-13-2020
11:22:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: R
eissued:Op
enedCLINICAL -
Thank you. Please
submit a SAE
safety update with
the information
that the subject
driving.
Nov-11-2020
23:23:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: A
nsweredAE #2 has been
entered as motor
vehicle accident
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0970040
Page 125 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-11-2020
20:31:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: R
eissued:Op
enedCLINICAL - if the
subject was the
driver, please enter
an AE for motor
vehicle accident
now
Nov-11-2020
11:44:56
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: A
nsweredThis has been
noted to be
included in the
next SAE update
Nov-10-2020
11:10:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: O
penedCLINICAL Please
report the subject
status as vehicle
DRIVER as a SAE
safety update
(AER
#2020411870).
Oct-27-2020
16:17:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Oct-27-2020
13:32:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredChanged
Information
Oct-27-2020
13:32:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
colon injur
yChanged
Information
Oct-23-2020
03:58:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: O
penedClarify
DAMAGED
COLON as
follows...Clarify
DAMAGED. Are
you reporting
RADIATION
DAMAGE?
INJURY?
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0970041
Page 126 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
PATHOLOGICAL
DAMAGE? Other?
Please update the
verbatim term to
clarify. Thank you.
Oct-22-2020
21:45:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
Damaged c
olonInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 17:40:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 UNK:UNKTranscription Error
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 16:52:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-16-2020 14:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/23/2020 UNK:UNKNew Information
Nov-16-2020 14:29:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data updated
Nov-15-2020 11:09:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Event
is ongoing;
however subject is
now s/p colostomy
for 4 weeks. Please
review for possible
end of event,
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970042
Page 127 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
resolved with new
longstanding
condition of
colostomy.
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-11-2020 20:32:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-11-2020 11:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered patient 1155 arrived
in clinic for follow
up on 10Nov2020
and released
records. Results will
be requested and
then updated in a
subsequent SAE
update in a few
days.
Nov-10-2020 11:17:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened CLINICAL - No
SAE update
received yet on
COVID test status
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970043
Page 128 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
during Hosp; this is
an independent
DMC request to
document COVID
test status -
including test = yes,
no or info not
available. If yes,
include date/results.
Nov-02-2020 23:31:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-02-2020 16:04:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered information and
request to submit
has been relayed
Oct-27-2020 23:46:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - Thank
you. Please submit
COVID test date
with the test result,
in the upcoming
Safety update
Oct-27-2020 17:39:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered clinical covid
testing was
performed in the
hospital and was
negative. This will
be included in the
follow up
Oct-27-2020 12:34:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020411870] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970044
Page 129 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-26-2020 06:39:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-26-2020 06:26:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE Damaged
colon: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Damaged
colon: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970045
Page 130 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
NO
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-01-2020 13:16:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Oct-31-2020 12:19:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Patient was the
driver. Additional
indication will be
entered
Oct-23-2020 14:56:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Please refer to CRF
guidelines and
clarify if Motor
Vehicle Accident
should be captured
as a separate entry
(if subject was
driver)
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0970046
Page 131 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Motor vehicle accident
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020 14:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-16-2020 14:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVED
WITH SEQUELAENew Information
Nov-16-2020 14:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE colon
injury: Response to
"What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970047
Page 132 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-22-2020 21:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-26-2020 06:39:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020411870Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0970048
Page 133 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
motor vehicle accidentInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/16/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970049
Page 134 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-03-2020 02:54:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-02-2020 15:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Nov-02-2020 15:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
Nov-01-2020 22:51:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete this item.
Thank you.
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-03-2020 06:34:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed downgraded to non
serious
Nov-02-2020 16:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Nov-02-2020 16:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Nov-01-2020 08:34:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Nov-01-2020 08:34:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON: r
vehicle
accident(Onset
date:16Oct2020) is
not reported to
Safety database but
marked serious on
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970050
Page 135 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE motor
vehicle accident:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serioInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970051
Page 136 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
us event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
driving accidentInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970052
Page 137 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-31-2020 12:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970053
Page 138 of 164
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-16-2020 00:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-16-2020 00:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-16-2020 00:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970054
Page 139 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 00:14:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970055
Page 140 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021 00:14:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at V
accination 1/2Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970056
Page 141 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021 00:14:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021 00:14:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970057
Page 142 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 00:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970058
Page 143 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-03-2021 00:15:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/27/2021Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970059
Page 144 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-03-2021 00:16:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-03-2021 00:16:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-03-2021 00:16:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970060
Page 145 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 00:16:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 00:16:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 18:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-03-2021 02:17:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 00:16:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 00:16:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0970061
Page 146 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Feb-17-2021 18:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1LWDInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021 18:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1LWDInitial Entry
5.b
Date Location User Value Reason
Feb-17-2021 18:39:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1LWFInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-17-2021 18:39:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1LWFInitial Entry
5.c
Date Location User Value Reason
Feb-17-2021 23:09:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBV4SInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-17-2021 23:09:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLBV4SInitial Entry
5.d
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970062
Page 147 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Feb-17-2021 23:09:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBV4TInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-17-2021 23:09:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLBV4TInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970063
Page 148 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 00:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 00:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 17:59:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-03-2021 02:17:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 00:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 00:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0970064
Page 149 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Feb-17-2021 17:59:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1LXPInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021 17:59:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1LXPInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970065
Page 150 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021 15:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970066
Page 151 of 164
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-03-2021 00:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0970067
Page 152 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
01:18:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse
satisfies query
Feb-23-2021
14:37:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answere
dChanged data per
query
Feb-22-2021
02:53:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedPDQ: RQ:1:
Thank you for
response,
Vaccination form
unfreeze. Please
update the data
as per previous
query. Thank
you.
Feb-22-2021
02:49:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedPer site
confirmation_PD
tracker updated
Feb-18-2021
22:40:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dData was entered
incorrectly. Date
has been
corrected. Please
unfreeze
Vaccination CRF
to enter correct
data
Feb-18-2021
22:40:20ACV0PFEINFP6000 Data En
try:Data was entered
incorrectly. Date
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970068
Page 153 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00)
Central Time
(US &
Canada)Feb/18/2
021has been
corrected. Please
unfreeze
Vaccination CRF
to enter correct
data
Feb-16-2021
03:28:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedPDQ: Date of
visit
V102_VAX4 is
out of window
for 12 days from
V101_VAX3
Dose Date.
Please verify and
update. Else,
confirm in query
response
appropriately.
Feb-06-2021
00:51:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
Feb/3/20
21Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0970069
Page 154 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-06-2021 00:52:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-06-2021 00:52:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-27-2021 17:25:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 22:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/18/2021Transcription Error
Feb-08-2021 06:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-06-2021 00:52:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-06-2021 00:52:24 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0970070
Page 155 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)YES
Date of Collection:
Feb/3/2021
5.a
Date Location User Value Reason
Feb-27-2021 17:25:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTV25JInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-27-2021 17:25:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTV25JInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0970071
Page 156 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-24-2021 06:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-23-2021 14:37:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-23-2021 14:37:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021 09:48Transcription Error
Feb-19-2021 10:51:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you.
Page is now
unfrozen to update.
Feb-18-2021 22:41:53
(UTC-06:00) CentralACV0PFEINFP6000 Query 1: Answered Please unfreeze
form for correction
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970072
Page 157 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
Feb-18-2021 22:40:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Dose Date is not
equal to Date of
Visit 18/Feb/2021 of
the corresponding
Visit. Please review
and update as
appropriate.
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/3/2021 09:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970073
Page 158 of 164
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-06-2021 00:52:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970074
Page 159 of 164
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 05:22:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-24-2021 04:11:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Deleted Query is invalid or
does not apply
Feb-23-2021 14:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered erroneous visit
entered
Feb-23-2021 14:36:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Feb-23-2021 14:35:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Visit,
19/Dec/2021 is a
future date relative
to when it was
entered on 23/Feb
/2021. Please
correct.
Feb-23-2021 14:35:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/19/2021Transcription Error
Feb-23-2021 14:35:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (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-2021-5683-0970075
Page 160 of 164
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2. Erroneous Visit
Date Location User Value Reason
Feb-23-2021 14:36:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970076
Page 161 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-16-2020 00:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-26-2020 04:37:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-25-2020 16:32:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Patient was
contacted on
21OCT2020 after
alert from ediary
was received.
Patient informed
that they were in a
car accident and
was currently
hospitalized.
Symptoms were
reviewed to not be
related to
COVID19. No visit
was scheduled
Nov-23-2020 02:49:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
21OCT2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Nov-17-2020 15:21:20
(UTC-06:00) CentralACV0PFEINFP6000 Query 1: Candidate Illness eDiary:
Subject reported
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970077
Page 162 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) "Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
21OCT2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Sep-28-2020 12:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-28-2020 12:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-11-2021 23:42:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed entered in error
Mar-11-2021 06:09:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered patient symptom
report in diary was
entered in error
upon
communication with
patient and started in
7 day window from
Vaccination. This
was determined to
be due to IP by PI
and no potential
covid visit was
triggered
Mar-10-2021 00:52:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened RQ1: Thank you for
response. However,
Vax4 is on
18Feb2021 and
Covid Illness
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970078
Page 163 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
reported in eDiary
on 26FEB2021
which is not within
7 day window.
Please review and
update as
appropriate, else
clarify.
Mar-09-2021 17:04:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered upon contact with
patient, they began
symptoms during
the 7 day
reactogenicity
period after
vaccination and was
determined to be
related to IP, and not
triggering a potential
covid visit.
Mar-03-2021 14:02:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
26FEB2021. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Dec-16-2020 00:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/8/2020Initial Entry
Sep-28-2020 12:53:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
Sep-28-2020 12:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/25/2020Initial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0970079
Page 164 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941155 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-17-2020 08:33:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30ca\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0970080