125742 S1 M5 CRF c4591001 1146 11461109

Document text

Page 1 of 134
***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: 11461109 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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808848
Page 2 of 134
***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: 11461109 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/25/2020
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808849
Page 3 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11461109]
2.Birth Date: /1958
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808850
Page 4 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808851
Page 5 of 134
***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: 11461109 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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808852
Page 6 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808853
Page 7 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Statin Allergy]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 Diabetes]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808854
Page 8 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High Cholesterol]
Start Date: UNK/UNK/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Blockage]
Start Date: Nov/UNK/2017
Ongoing: NO
End Date:
Nov/UNK/2017
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Stent Placement]
Start Date: Nov/UNK/2017
Ongoing: NO
End Date:
Nov/UNK/2017
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Peripheral Vascular Disease]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808855
Page 9 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Amputation of left and right great toe]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808856
Page 10 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [182.2]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [24.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808857
Page 11 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [239718]
3.Randomization Group: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808858
Page 12 of 134
***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: 11461109 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/25/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1953]
5.bSample ID [BP1954]
5.cSample ID [BP1955]
5.dSample ID [BPHCVY]
5.eSample ID [BPHCVZ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808859
Page 13 of 134
***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: 11461109 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/25/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1952]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808860
Page 14 of 134
***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: 11461109 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/25/2020 11:51
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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808861
Page 15 of 134
***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: 11461109 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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808862
Page 16 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808863
Page 17 of 134
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808864
Page 18 of 134
***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: 11461109 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/15/2020
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 [BP9C7D]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808865
Page 19 of 134
***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: 11461109 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/15/2020 10:02
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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808866
Page 20 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808867
Page 21 of 134
***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: 11461109 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/15/2020
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 [BRTWWV]
5.bSample ID [BPW22R]
5.cSample ID [BRTWWC]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808868
Page 22 of 134
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808869
Page 23 of 134
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 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:
Mar/10/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS1YHH]
5.bSample ID [BS1YHL]
5.cSample ID [BR49S3]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808870
Page 24 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808871
Page 25 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808872
Page 26 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808873
Page 27 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808874
Page 28 of 134
***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: 11461109 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:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808875
Page 29 of 134
***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: 11461109 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: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808876
Page 30 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808877
Page 31 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808878
Page 32 of 134
***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: 11461109 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?
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808879
Page 33 of 134
***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: 11461109 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:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808880
Page 34 of 134
***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: 11461109 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:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808881
Page 35 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808882
Page 36 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808883
Page 37 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808884
Page 38 of 134
***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: 11461109 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/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808885
Page 39 of 134
***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: 11461109 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: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808886
Page 40 of 134
***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: 11461109 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:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808887
Page 41 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808888
Page 42 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Increase in baseline blood sugar  Sep/1/2020 U
NK:UNK YES  Repeating
Pages
 2.ADVERSE
EVENT 2  Mid Left Anterior Descending Cor
onary Artery Occlusion Jan/20/2021 1
2:00 NO
End Date Time:
Jan/20/2021 16:00
 Repeating
Pages
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808889
Page 43 of 134
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 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)[Increase in baseline blood sugar]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[History of type 2 diabetes. Over indulgence and not monitoring blood
sugar]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808890
Page 44 of 134
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808891
Page 45 of 134
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 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)[Mid Left Anterior Descending Coronary Artery Occlusion]
4.Start Date Time: Jan/20/2021 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/20/2021 16:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[History of coronary artery disease]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808892
Page 46 of 134
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 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? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808893
Page 47 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808894
Page 48 of 134
***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: 11461109 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[ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808895
Page 49 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808896
Page 50 of 134
***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: 11461109 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: //
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808897
Page 51 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808898
Page 52 of 134
***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: 11461109 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?
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808899
Page 53 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808900
Page 54 of 134
***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: 11461109 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?
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808901
Page 55 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808902
Page 56 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808903
Page 57 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808904
Page 58 of 134
***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: 11461109 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:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808905
Page 59 of 134
***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: 11461109 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?
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808906
Page 60 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808907
Page 61 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808908
Page 62 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808909
Page 63 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808910
Page 64 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808911
Page 65 of 134
***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: 11461109 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 [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808912
Page 66 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808913
Page 67 of 134
***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: 11461109 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 willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808914
Page 68 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808915
Page 69 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808916
Page 70 of 134
***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: 11461109 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: [ ]
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808917
Page 71 of 134
***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: 11461109 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/15/2020
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808918
Page 72 of 134
***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: 11461109 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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808919
Page 73 of 134
***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: 11461109 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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808920
Page 74 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-25-2020 12:41:42 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808921
Page 75 of 134
***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: 11461109 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 Feb-12-2021 19:58:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Falcone  Approved Oct-23-2020 17:28:02 (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.
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808922
Page 76 of 134
***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: 11461109 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-25-2020 12:40:54
(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-25-2020 12:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808923
Page 77 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 12:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/25/2020Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808924
Page 78 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020 12:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11461109Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 12:40:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1958Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 12:41:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 12:41:20
(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-25-2020 12:41:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808925
Page 79 of 134
***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: 11461109 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-25-2020 12:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808926
Page 80 of 134
***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: 11461109 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-25-2020 12:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 12:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 12:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808927
Page 81 of 134
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 12:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Statin Allerg
y
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Statin AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 12:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 12:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808928
Page 82 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b
Date Location User Value Reason
Aug-25-2020 12:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Type 2 Diabe
tes
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type 2 DiabetesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 12:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020 12:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808929
Page 83 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-25-2020 12:43:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:43:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:43:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 12:43:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020 12:43:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808930
Page 84 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-25-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:Coronary Artery
Disease
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery DiseaseInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 12:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020 12:44:26 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808931
Page 85 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Number
:5
Medical History T
erm:High Cholest
erol
Start Date: UNK/UNK/2
019
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:44:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:44:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
High CholesterolInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020 12:44:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020 12:44:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-25-2020 12:44:57
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu 6Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808932
Page 86 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) mber:
Medical Histo
ry Term:Coronary Artery
Blockage
Start Date: Nov/UNK/2017
Ongoing: NO
End Date:
Nov/UNK/20
17
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery BlockageInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020 12:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2017Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020 12:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/UNK/2017Initial Entry
1.g
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808933
Page 87 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-25-2020 12:45:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histo
ry Term:Coronary Stent P
lacement
Start Date: Nov/UNK/2017
Ongoing: NO
End Date:
Nov/UNK/20
17Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808934
Page 88 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:45:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:45:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Stent PlacementInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020 12:45:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020 12:45:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/UNK/2017Initial Entry
1.h
Date Location User Value Reason
Aug-25-2020 12:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histo
ry Term:Peripheral Vascul
ar Disease
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808935
Page 89 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.h Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Peripheral Vascular DiseaseInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-25-2020 12:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020 12:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-25-2020 12:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical His
tory Term:Amputation of left a
nd right great toe
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808936
Page 90 of 134
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.i Line/MH Number:
Date Location User Value Reason
Aug-25-2020 12:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 12:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Amputation of left and right gre
at toeInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-25-2020 12:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-25-2020 12:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808937
Page 91 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
182.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 12:48:31 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808938
Page 92 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) 24.7
7.a
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.5
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 12:48:31
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808939
Page 93 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808940
Page 94 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
239718Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808941
Page 95 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 12:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 12:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 12:49:23
(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-25-2020 12:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1953Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808942
Page 96 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1953Initial Entry
5.b
Date Location User Value Reason
Aug-25-2020 14:16:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1954Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020 14:16:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1954Initial Entry
5.c
Date Location User Value Reason
Aug-25-2020 14:16:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1955Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020 14:16:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1955Initial Entry
5.d
Date Location User Value Reason
Aug-25-2020 14:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHCVYInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808943
Page 97 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sample ID
Date Location User Value Reason
Aug-25-2020 14:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPHCVYInitial Entry
5.e
Date Location User Value Reason
Aug-25-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHCVZInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-25-2020 14:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPHCVZInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808944
Page 98 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 12:49:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 12:49:33
(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-25-2020 14:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 12:49:33
(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-25-2020 12:49:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 14:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1952Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808945
Page 99 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 14:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1952Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808946
Page 100 of 134
***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: 11461109 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-25-2020 12:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 12:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 12:49:56
(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-25-2020 12:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020 11:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 12:49:56
(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-25-2020 12:49:56 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808947
Page 101 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Aug-25-2020 12:49:56
(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-25-2020 12:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 12:49:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808948
Page 102 of 134
***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: 11461109 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-25-2020 12:50:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808949
Page 103 of 134
***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: 11461109 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-15-2020 10:58:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808950
Page 104 of 134
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 10:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020 10:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 10:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-15-2020 10:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020 10:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808951
Page 105 of 134
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020 10:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808952
Page 106 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 10:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 10:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 15:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 10:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-15-2020 10:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 15:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9C7DInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808953
Page 107 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 15:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9C7DInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808954
Page 108 of 134
***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: 11461109 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-15-2020 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 10:59:23
(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-15-2020 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 10:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 10:59:23
(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-15-2020 10:59:23 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808955
Page 109 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-15-2020 10:59:23
(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-15-2020 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-15-2020 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808956
Page 110 of 134
***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: 11461109 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-15-2020 10:19:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808957
Page 111 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 10:19:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 10:19:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 14:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 10:19:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 10:19:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 14:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTWWVInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808958
Page 112 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 14:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTWWVInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 14:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW22RInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 14:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW22RInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 14:41:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTWWCInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 14:41:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTWWCInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808959
Page 113 of 134
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 09:25:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808960
Page 114 of 134
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 09:31:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 09:31:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User ValueReason
Mar-12-2021
16:38:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Mar-12-2021
09:25:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dChanged data per
query
Mar-12-2021
09:14:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW7691464;Date
of collection is
entered, but “Date
of Visit” is not yet
initiated at the
corresponding visit.
Please review and
update as
appropriate.
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808961
Page 115 of 134
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-10-2021
09:32:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Del
etedClose Auto Query
Mar-10-2021
09:31:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ca
ndidat
e'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-10-2021
09:31:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YES
Date
of C
ollec
tion:
Ma
r/1
0/2
02
1Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021 09:32:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS1YHHInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 09:32:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS1YHHInitial Entry
5.b
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808962
Page 116 of 134
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-10-2021 09:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS1YHLInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021 09:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS1YHLInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021 09:32:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR49S3Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-10-2021 09:32:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR49S3Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808963
Page 117 of 134
***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: 11461109 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-15-2020 10:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 10:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 10:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808964
Page 118 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808965
Page 119 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Robert
FalconeForm Created
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808966
Page 120 of 134
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-05-2020
12:04:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
Oct-05-2020
10:24:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredChanged
Information
Oct-05-2020
10:24:38
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Increase in b
aseline blood
sugarChanged
Information
Oct-05-2020
09:32:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Ope
nedClarify the term
WORSENING
BLOOD
SUGAR as
follows..The
term appears to
be unclear. If
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808967
Page 121 of 134
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
reporting
BLOOD
SUGAR -
INCREASED
then edit as
such. Otherwise
please clarify
the term further.
Thank you.
Oct-05-2020
08:27:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Worsening bl
ood sugarInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-04-2021 09:40:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-22-2020 07:14:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject stated that
it was ongoing
Dec-14-2020 18:23:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: Please
verify if Increase in
Baseline Blood
Sugar is ongoing,
then update the
END DATE and
OUTCOME as
appropriate.
Oct-07-2020 09:38:22
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808968
Page 122 of 134
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
Oct-06-2020 18:52:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject still has
diabetes.
Oct-06-2020 17:37:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
verify if Increase in
Baseline Blood
Sugar is ongoing,
then update the
END DATE and
OUTCOME as
appropriate.
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-05-2020 08:27:17
(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
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-05-2020 08:27:17 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808969
Page 123 of 134
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)NO
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-05-2020 08:27:17
(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:
History of type 2 diabetes
. Over indulgence and not
monitoring blood sugarInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-05-2020 08:27:17
(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
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (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-2021-5683-0808970
Page 124 of 134
***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, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-05-2020 08:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0808971
Page 125 of 134
***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, Queries, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 12:32:49
(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
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
Mid Left Anterior Descending C
oronary Artery OcclusionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
Jan/20/2021 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
NO
End Date Time:
Jan/20/2021 16:00Initial Entry
6. Toxicity Grade:
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808972
Page 126 of 134
***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, Queries, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData 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
Mar-12-2021 15:06:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls review
seriousness criteria
and confirm this is
not an SAE or
important medical
event (IME) eg
required
procedures to
prevent SAE.
Thanks
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
NOT RELATED
If Not Related to study treatmeInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808973
Page 127 of 134
***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, Queries, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
nt(s), this event is due to:
OTHER
If Other, specify:
History of coronary artery
disease
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 12:32:49
(UTC-05:00) EasternACV0PFEINFP6000  Robert
FalconeData Entry:
NOInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808974
Page 128 of 134
***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, Queries, Not Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808975
Page 129 of 134
***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: 11461109 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-18-2021 13:16:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808976
Page 130 of 134
***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: 11461109 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-18-2021 13:17:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808977
Page 131 of 134
***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: 11461109 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-12-2021 19:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021 19:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808978
Page 132 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-15-2020 10:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-25-2020 12:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-11-2020 00:56:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site
confirmation-
reported in error
Dec-10-2020 09:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject
documenting covid
symptoms in error.
Dec-06-2020 13:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
17NOV2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Oct-15-2020 10:20:02 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808979
Page 133 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Oct/15/2020
Aug-25-2020 12:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
Aug-25-2020 12:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808980
Page 134 of 134
***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: 11461109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020 17:27:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robert
FalconeData Entry:
Click Here to EnableInitial Entry
090177e196ae3eca\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808981