Document text
Page 1 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808982
Page 2 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808983
Page 3 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11461133]
2.Birth Date: 1989
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808984
Page 4 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808985
Page 5 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808986
Page 6 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808987
Page 7 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808988
Page 8 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [242.5]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [35.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808989
Page 9 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808990
Page 10 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [69706]
3.Randomization Group: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808991
Page 11 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP197T]
5.bSample ID [BP197V]
5.cSample ID [BP197W]
5.dSample ID [BPHCX8]
5.eSample ID [BPHCX9]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808992
Page 12 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP197R]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808993
Page 13 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 11:30
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
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808994
Page 14 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808995
Page 15 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808996
Page 16 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808997
Page 17 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808998
Page 18 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9C96]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808999
Page 19 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 07:37
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
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809000
Page 20 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809001
Page 21 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
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 [BPW267]
5.bSample ID [BRTX1C]
5.cSample ID [BRTX1B]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809002
Page 22 of 138
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809003
Page 23 of 138
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809004
Page 24 of 138
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809005
Page 25 of 138
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809006
Page 26 of 138
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809007
Page 27 of 138
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809008
Page 28 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809009
Page 29 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809010
Page 30 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809011
Page 31 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809012
Page 32 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809013
Page 33 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809014
Page 34 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809015
Page 35 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809016
Page 36 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809017
Page 37 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809018
Page 38 of 138
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809019
Page 39 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809020
Page 40 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809021
Page 41 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809022
Page 42 of 138
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Vaginal Bleeding Jan/21/2021 UNK:U
NK NO
End Date Time:
Jan/22/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Exposure during pre
gnancy UNK/UNK/2021 UN
K:UNK NO
End Date Time:
UNK/UNK/2021 UNK:
UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 spontaneous abortio
n Jan/21/2021 UNK:U
NK NO
End Date Time:
Jan/21/2021 UNK:UNK
Repeating
Pages
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809023
Page 43 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Vaginal Bleeding]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious 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.NO
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809024
Page 44 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[Vaginal bleeding due to a spontaneous abortion]
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[2021058244]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809025
Page 45 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Exposure during pregnancy]
4.Start Date Time: UNK/UNK/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
UNK/UNK/2021 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:
[Vaginal Bleeding, No diagnosis from physician of spontaneous abortion.]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809026
Page 46 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809027
Page 47 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[spontaneous abortion]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/21/2021 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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious 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.NO
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809028
Page 48 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[loss of fetus]
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[2021058244]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809029
Page 49 of 138
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809030
Page 50 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809031
Page 51 of 138
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809032
Page 52 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: //
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809033
Page 53 of 138
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809034
Page 54 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809035
Page 55 of 138
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809036
Page 56 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809037
Page 57 of 138
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809038
Page 58 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809039
Page 59 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809040
Page 60 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809041
Page 61 of 138
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809042
Page 62 of 138
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809043
Page 63 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809044
Page 64 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809045
Page 65 of 138
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809046
Page 66 of 138
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809047
Page 67 of 138
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809048
Page 68 of 138
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809049
Page 69 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809050
Page 70 of 138
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809051
Page 71 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809052
Page 72 of 138
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809053
Page 73 of 138
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809054
Page 74 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809055
Page 75 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809056
Page 76 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809057
Page 77 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-27-2020 12:15:35 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809058
Page 78 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-27-2020 12:16:01 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809059
Page 79 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 Jan-27-2021 14:01:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Falcone Approved Nov-03-2020 14:58:31 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFalcone, 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.
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809060
Page 80 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 12:14:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 12:14:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809061
Page 81 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 12:14:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809062
Page 82 of 138
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 12:14:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11461133Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 12:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 12:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 12:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 12:15:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809063
Page 83 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 12:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809064
Page 84 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 12:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 12:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 12:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809065
Page 85 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
242.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.8Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809066
Page 86 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 12:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809067
Page 87 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809068
Page 88 of 138
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020 12:17:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809069
Page 89 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 12:17:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 12:17:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69706Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809070
Page 90 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 12:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 12:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 14:36:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 12:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 12:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 14:36:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP197TInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809071
Page 91 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 14:36:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP197TInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 14:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP197VInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 14:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP197VInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 14:36:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP197WInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 14:36:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP197WInitial Entry
5.d
Date Location User Value Reason
Aug-27-2020 14:36:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHCX8Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809072
Page 92 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 14:36:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHCX8Initial Entry
5.e
Date Location User Value Reason
Aug-27-2020 14:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHCX9Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 14:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHCX9Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809073
Page 93 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 12:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 12:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 14:36:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 12:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 12:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 14:36:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP197RInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809074
Page 94 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 14:36:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP197RInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809075
Page 95 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 11:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809076
Page 96 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7. Route:
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
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
Aug-27-2020 12:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809077
Page 97 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020 12:18:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809078
Page 98 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 08:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809079
Page 99 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 08:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 08:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.1
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 08:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 08:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 08:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809080
Page 100 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 08:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809081
Page 101 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809082
Page 102 of 138
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 08:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809083
Page 103 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 08:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 08:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 10:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 08:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-18-2020 08:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 10:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9C96Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809084
Page 104 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 10:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9C96Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809085
Page 105 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 07:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809086
Page 106 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7. Route:
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 08:06:57
(UTC-05:00) Eastern
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-18-2020 08:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809087
Page 107 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 07:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809088
Page 108 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 14:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 14:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 14:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 14:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW267Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 14:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW267Initial Entry
5.b
Date Location User Value Reason
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809089
Page 109 of 138
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:46:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTX1CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 14:46:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTX1CInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 14:46:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTX1BInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 14:46:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTX1BInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809090
Page 110 of 138
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-28-2020 07:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 07:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 07:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809091
Page 111 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809092
Page 112 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809093
Page 113 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809094
Page 114 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-24-2021 16:12:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed ok
Feb-18-2021 11:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered will do
Feb-08-2021 14:09:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Thanks for
confirming. Please
make every effort
possible to obtain
further information
Feb-01-2021 14:48:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered No further follow
ups were done
according to the
patient. Will speak
with them to see if
they followed up
with a physician and
if anything was
preformed and will
update accordingly.
Feb-01-2021 11:48:44
(UTC-05:00) EasternACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened CLINICAL_ Kindly
provide further
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809095
Page 115 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) details on symptoms
of onset, lab results
and gynultrasound
performed in a FU
form to be added to
the safety report.
Thanks.
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vaginal BleedingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial 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
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809096
Page 116 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-01-2021 10:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Vaginal
Bleeding: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809097
Page 117 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-13-2021 08:59:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-10-2021 08:24:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE was submitted
for 11461221
(Partner). Once the
term is confirmed then
will update log.
Feb-09-2021 15:09:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened 1.If the event of
Spontaneous abortion
has been confirmed,
then event term can be
updated. 2. By
reporting the EDP on
the male partner a
duplicated safety
report is created for
the same SAE. Pls
report event for the
corresponding partner.
Thanks
Feb-01-2021 16:35:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered The SAE submitted
for 11461133 stated
vaginal bleeding.
Should we submit a
follow up SAE
changing the term to
spontaneous abortion
instead of vaginal
bleeding. The SAE for
the male partner
(11461221) stated
partner exposed
during pregnancy.
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809098
Page 118 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-01-2021 11:51:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Spontaneous abortion
is an additional SAE
in itself. The event has
been reported for male
partner
(AER#2021064681).
Please confirm, revise
and update AElog
accordingly. Thanks
Jan-29-2021 09:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Jan-29-2021 08:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical Monitor_ Per
protocol section 8.3.5,
abnormal outcomes of
pregnancy are
considered SAEs.
Please revise and
update AElog
accordingly. Thanks
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Vaginal bleeding due to a
spontaneous abortionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809099
Page 119 of 138
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-27-2021 14:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-01-2021 10:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021058244Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809100
Page 120 of 138
***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, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
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
Feb-24-2021 15:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-24-2021 09:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-24-2021 09:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure during pregnancyTranscription Error
Feb-24-2021 04:28:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON: The
event term was
recorded as
'PARTNER
EXPOSED DURING
PREGNANCY ', Per
3 Nov EDP guidance
(study
communication),
term should be
recorded as Exposure
during pregnancy.
Please confirm and
update accordingly
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809101
Page 121 of 138
***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, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PARTNER EXPOSED DURING
PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
UNK/UNK/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
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
Mar-11-2021 05:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
Mar-10-2021 14:44:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Mar-10-2021 07:40:26 ACV0PFEINFP6000 auto query Query 4: Candidate For AE Exposure during
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809102
Page 122 of 138
***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, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)(autoquery) pregnancy : Response to "Is
the adverse event serious?"
is 'No' but "Serious Adverse
Event Number" is present.
Mar-10-2021 07:40:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Mar-10-2021 07:40:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Mar-09-2021 04:10:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened SAE
RECON:AER#2021233784,
Exposure during pregnancy
event was updated to non
serious in Safety database.
Per Clinical 'Event should
be recorded as non-serious
inform'. Please confirm and
update accordingly.
Mar-04-2021 04:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed event recorded in SDB
Mar-01-2021 12:12:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate Pending SDB update
Mar-01-2021 06:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered submitted
Feb-24-2021 04:34:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021058244,
Exposure during pregnancy
event missing in Safety
database.Per Clinical
review, please submit
follow up safety report for
AER#2021058244 as an
additional separate SAE.
Feb-15-2021 23:14:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be addressed
internally
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809103
Page 123 of 138
***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, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE PARTNER
EXPOSED DURING
PREGNANCY : Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
NO
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809104
Page 124 of 138
***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, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
Vaginal Bleeding, No diagno
sis from physician of sponta
neous abortion.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809105
Page 125 of 138
***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, Not Verified, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021 08:16:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-11-2021 05:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: downgraded to non
serious
Mar-04-2021 04:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021233784new aer
Feb-15-2021 23:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021058244Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809106
Page 126 of 138
***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, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
spontaneous abortionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809107
Page 127 of 138
***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, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
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
Mar-10-2021 08:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 2: Closed Response satisfies
query
Mar-10-2021 07:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Mar-10-2021 07:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?Transcription Error
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809108
Page 128 of 138
***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, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Other medically important seri
ous event
YES
Mar-04-2021 11:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Form is now
unfrozen.
Mar-02-2021 08:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unfreeze
Feb-28-2021 11:20:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 2: Opened GPDClin: The
"death" in SAE
criteria means the
death of the subject
not the fetus. Please
change it to "No".
Feb-19-2021 03:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-18-2021 16:04:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?Transcription Error
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809109
Page 129 of 138
***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, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YES
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE spontaneous
abortion: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NOInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809110
Page 130 of 138
***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, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Other medically important seri
ous 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
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
loss of fetusInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809111
Page 131 of 138
***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, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021 16:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-19-2021 03:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021058244Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809112
Page 132 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-14-2021 12:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809113
Page 133 of 138
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-14-2021 12:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retur
n for Vaccination 3 OR otherwise n
ot eligibleInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809114
Page 134 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021 10:22:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-09-2021
18:50:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedPer site response.
Mar-08-2021
19:57:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dsubject was assigned to
placebo and return to
safety FUP
Mar-03-2021
00:42:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dAs Subject is NOT
willing to return for
Vax 3, please confirm
if participant was
assigned to placebo and
returned to safety FUP
or treatment Unblinded
before subject
contacted to confirm
willingness/eligibility
to proceed with Vax 3,
Else, clarify.
Mar-02-2021
10:01:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dPatient was unblinded
and eligibility assessed,
but is pregnant so not
eligible for vaccination.
Please advise.
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0809115
Page 135 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-01-2021
03:27:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM : REVAX CONF
form unfrozen. Please
review and update data
as appropriate. Thank
you.
Feb-26-2021
14:17:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dFurther Vaccination
Confirmation CRF is
frozen.
Feb-22-2021
17:04:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7350442;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-15-2021
10:22:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809116
Page 136 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-01-2021 11:45:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-27-2021 13:51:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered entered
Jan-27-2021 13:14:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Thank you for your
response. Howerver,
no updates have been
made to AElog.
Please clarify.
Jan-27-2021 10:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AElog has been
updated
Jan-27-2021 09:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Clinical_ An SAE of
bleeding has been
reported to safety
(AER#2021058244).
Pls revise and update
AElog.
Oct-28-2020 07:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020 12:17:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-27-2020 12:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-19-2021 03:36:52
(UTC-05:00) EasternACV0PFEINFP6000 Query 1: Closed Response satisfies query
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809117
Page 137 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
Feb-18-2021 16:04:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered added on AE CRF
Feb-15-2021 23:19:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021058244
spontaneous abortion(onset
date:21Jan2021)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-28-2020 07:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/21/2020Initial Entry
Aug-27-2020 12:17:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-27-2020 12:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809118
Page 138 of 138
***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: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020 14:58:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Robert
FalconeData Entry:
Click Here to EnableInitial Entry
090177e196ae3ec0\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0809119