Document text
Page 1 of 322
***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: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809120
Page 2 of 322
***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: 11461152 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/28/2020
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809121
Page 3 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11461152]
2.Birth Date: /1959
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:
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809122
Page 4 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809123
Page 5 of 322
***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: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809124
Page 6 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809125
Page 7 of 322
***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: 11461152 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:[Claudication]
Start Date: Jun/UNK/2005
Ongoing: NO
End Date:
Jul/UNK/2019
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic cough (smokers cough)]
Start Date: Dec/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Myocardial Infarction]
Start Date: Jul/10/2010
Ongoing: NO
End Date:
Jul/13/2010
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809126
Page 8 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bradycardia]
Start Date: Jul/UNK/2010
Ongoing: NO
End Date:
Jul/13/2010
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Lung Cancer]
Start Date: Dec/UNK/2017
Ongoing: NO
End Date:
Dec/28/2017
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809127
Page 9 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [144.4]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [21.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809128
Page 10 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [244831]
3.Randomization Group: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809129
Page 11 of 322
***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: 11461152 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/28/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP199Z]
5.bSample ID [BP19B0]
5.cSample ID [BP19B1]
5.dSample ID [BPHCYB]
5.eSample ID [BPHCYC]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809130
Page 12 of 322
***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: 11461152 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/28/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP199W]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809131
Page 13 of 322
***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: 11461152 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/28/2020 13:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809132
Page 14 of 322
***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: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809133
Page 15 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809134
Page 16 of 322
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809135
Page 17 of 322
***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: 11461152 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/16/2020
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 [BP9C88]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809136
Page 18 of 322
***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: 11461152 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/16/2020 12:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809137
Page 19 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809138
Page 20 of 322
***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: 11461152 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/14/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTWWS]
5.bSample ID [BRTWWT]
5.cSample ID [BPW22F]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809139
Page 21 of 322
***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: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809140
Page 22 of 322
***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: 11461152 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 [BR49S6]
5.bSample ID [BS1YHV]
5.cSample ID [BS1YHR]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809141
Page 23 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809142
Page 24 of 322
***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: 11461152 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 [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809143
Page 25 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809144
Page 26 of 322
***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: 11461152 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 [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809145
Page 27 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809146
Page 28 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/8/2021
2.Date of First Symptom
Started:Feb/6/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/12/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809147
Page 29 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809148
Page 30 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
1.Not Applica
ble Not Appli
cable Not Applicable Not Applicable Not Appli
cable Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809149
Page 31 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809150
Page 32 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[Patient was in the hospital at time of telehealth call.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809151
Page 33 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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:
Feb/25/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[Subject was in hospital so was not able to self swab]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR4W5]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809152
Page 34 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809153
Page 35 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?YES
Has the subject been in intensive care due to potential
COVID-19 illness?
NO
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809154
Page 36 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Hospitalization Categor
yHospitalization T
ermAdmission D
ateOngoing Form Instance
1.HOSPITALIZATION ST
ATUS HOSPITAL Feb/6/2021 NO
Discharge D
ate:
Feb/12/202
1
Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809155
Page 37 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/6/2021
4.Ongoing? NO
Discharge Date:
Feb/12/2021
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809156
Page 38 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatmen
t Identifie
rCon Non-Drug Tr
eatments Pre-speci
fiedTreatment TreatmentStart
DateForm Insta
nce
1.1 YES HIGH FLOW O
XYGEN THERA
PY HIGH FLOW O
XYGEN THERA
PY Feb/9
/2021
Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809157
Page 39 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment
Identifier?[1]
2.Concomitant Non-drug
Treatment Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Feb/9/2021
6.Ongoing? NO
End Date:
Feb/9/2021
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809158
Page 40 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19
Illness?NO
3.Toxicity Grade: 2
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809159
Page 41 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809160
Page 42 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809161
Page 43 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category f
or Lab TestVendo
r Nam
eCollect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
1.CLINICAL
CHEMIST
RY [ ] Feb/11/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
[ ] C Reactive Pro
tein_PX329 [ ]
[ ] Alanine Amin
otransferase_P
X30 [ ]
[ ] Aspartate Ami
notransferase_
PX28 [ ]
[ ] Alkaline Phosp
hatase_PX35 [ ]
[ ] Bilirubin_PX2
1 [ ]
47 Blood Urea Nit
rogen_PX47 19
48 Creatinine_PX
48 .62 Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809162
Page 44 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[ ]
3.Collection Date: Feb/11/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [ ]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809163
Page 45 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.bSponsor ID: [ ]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [ ]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809164
Page 46 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.dSponsor ID: [ ]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [ ]
Test: Bilirubin_PX21
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809165
Page 47 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[7]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.62]
Not Done:
LNMT Low
[.9]
High
[1.3]
Unit
mg/dL
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809166
Page 48 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collecti
on Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
1.HEMATO
LOGY Hematology
general Feb/6/2
021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglo
bin_PX1 13.
3
2 Hematocr
it_PX2 39
3 Erythrocy
tes_PX3 [ ]
5 Platelets_
PX5 153
7 Leukocyt
es_PX7 [ ]
608 Neutrophi
ls_PX608
[ ]
609 Eosinophi
ls_PX609
0.2
612 Monocyte
s_PX612 0.7
610 Basophils
_PX610 0.2
611 Lymphoc
ytes_PX61.3 Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809167
Page 49 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collecti
on Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Res
ult:
11
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809168
Page 50 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[Hematology general]
3.Collection Date: Feb/6/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.3]
Not Done:
LNMT Low
[13]
High
[18]
Unit
g/dL
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809169
Page 51 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [39]
Not Done:
LNMT Low
[45]
High
[62]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809170
Page 52 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [153]
Not Done:
LNMT Low
[150]
High
[350]
Unit
g/dL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809171
Page 53 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.2]
Not Done:
LNMT Low
[1]
High
[6]
Unit
%
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809172
Page 54 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.7]
Not Done:
LNMT Low
[.2]
High
[1]
Unit
g/L
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.2]
Not Done:
LNMT Low
[0]
High
[300]
Unit
/uL
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809173
Page 55 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.3]
Not Done:
LNMT Low
[1]
High
[4.8]
Unit
10^3/uL
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809174
Page 56 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
1.Feb/6/2021 Record Identifier: Systolic: Diastolic:
1 135 90 Repeating Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809175
Page 57 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/6/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [135]
Diastolic: [90]
Respiratory Rate in
respirations/minute:[24]
Heart Rate in
beats/minute:[82]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809176
Page 58 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
1.Feb/6/2021 Record Identifier: Oxygen Saturation
1 92.0 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0809177
Page 59 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/6/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [92.0]
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(b) (4)
FDA-CBER-2021-5683-0809178
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809179
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809180
Page 62 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809181
Page 63 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0809182
Page 64 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date
of Ass
essme
ntLocati
on of A
ssessm
entImagi
ng M
ethodOverall AssessmentForm Inst
ance
1.Feb/6/
2021 CHEST
X-RA
Y ABNORMAL
If abnormal, specify findings:
Worsening opacification in the right upper lung wit
h history of right upper lobectomy. Findings are con
cerning for pneumonia.No acute osseous abnormalit
y.
Repeating
Pages
2.Feb/6/
2021 CHEST
CT S
CAN ABNORMAL
If abnormal, specify findings:
Consolidation with air bronchograms, within the rig
ht middle lobe which is suggestive of atelectasis ver
sus pneumonia. Few peripheral areas of groundglas
s within the left upper lobe. No Effusion
Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809183
Page 65 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/6/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Worsening opacification in the right upper lung with history of
right upper lobectomy. Findings are concerning for
pneumonia.No acute osseous abnormality.]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809184
Page 66 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/6/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Consolidation with air bronchograms, within the right middle
lobe which is suggestive of atelectasis versus pneumonia. Few
peripheral areas of groundglass within the left upper lobe. No
Effusion]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809185
Page 67 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/10/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809186
Page 68 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/10/2021Form: 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: 11461152 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 [BR49S7]
5.bSample ID [BS1YHW]
5.cSample ID [BS1YHS]
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(b) (4)
FDA-CBER-2021-5683-0809187
Page 69 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809188
Page 70 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
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(b) (4)
FDA-CBER-2021-5683-0809189
Page 71 of 322
***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: 11461152 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/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
FDA-CBER-2021-5683-0809190
Page 72 of 322
***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: 11461152 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: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809191
Page 73 of 322
***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: 11461152 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:
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809192
Page 74 of 322
***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: 11461152 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 [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809193
Page 75 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yAE Id
entifie
rAdverse EventStart Dat
eIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
1.ADVER
SE EVE
NT 1 Fall off ladder Oct/7/202
0 UNK:U
NK NO
End Date Time:
Oct/7/2020 U
NK:UNK
Repeating
Pages
2.ADVER
SE EVE
NT 2 Bruised ribs Oct/7/202
0 UNK:U
NK NO
End Date Time:
Oct/21/2020
UNK:UNK
Repeating
Pages
3.ADVER
SE EVE
NT 3 Chronic Obstructive Pulmo
nary Disease with acute exa
cerbation Feb/6/202
1 UNK:U
NK NO
End Date Time:
Feb/12/2021
UNK:UNK
Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809194
Page 76 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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)[Fall off ladder]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809195
Page 77 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[fall]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809196
Page 78 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809197
Page 79 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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)[Bruised ribs]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/21/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809198
Page 80 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[accident]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809199
Page 81 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809200
Page 82 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Chronic Obstructive Pulmonary Disease with acute
exacerbation]
4.Start Date Time: Feb/6/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809201
Page 83 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[Pneumonia]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809202
Page 84 of 322
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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?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[2021139031]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809203
Page 85 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedication
ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication E
rrors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809204
Page 86 of 322
***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: 11461152 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[ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809205
Page 87 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809206
Page 88 of 322
***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: 11461152 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: //
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809207
Page 89 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809208
Page 90 of 322
***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: 11461152 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?
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809209
Page 91 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809210
Page 92 of 322
***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: 11461152 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?
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809211
Page 93 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809212
Page 94 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809213
Page 95 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809214
Page 96 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11461152 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:
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809215
Page 97 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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?
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809216
Page 98 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809217
Page 99 of 322
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809218
Page 100 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809219
Page 101 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809220
Page 102 of 322
***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: 11461152 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 [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809221
Page 103 of 322
***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: 11461152 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 [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809222
Page 104 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809223
Page 105 of 322
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809224
Page 106 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809225
Page 107 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809226
Page 108 of 322
***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: 11461152 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: [ ]
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809227
Page 109 of 322
***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: 11461152 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/14/2020
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809228
Page 110 of 322
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809229
Page 111 of 322
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11461152 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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809230
Page 112 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-28-2020 14:45:14 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809231
Page 113 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809232
Page 114 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809233
Page 115 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809234
Page 116 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809235
Page 117 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809236
Page 118 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809237
Page 119 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809238
Page 120 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
7Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809239
Page 121 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
8Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809240
Page 122 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
9Feb-18-2021 16:05:24 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809241
Page 123 of 322
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11461152 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-08-2021 15:39:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Falcone Approved Jan-21-2021 08:24:02 (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.
N/A Dec-15-2020 10:30:26 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809242
Page 124 of 322
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
N/A
Approved Nov-09-2020 19:15:43 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Nov-09-2020 14:40:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Falcone Approved Oct-23-2020 17:16:31 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809243
Page 125 of 322
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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.
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809244
Page 126 of 322
***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: 11461152 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-28-2020
14:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020
14:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809245
Page 127 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020
14:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/28/2020Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809246
Page 128 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020
14:44:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11461152Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020
14:44:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1959Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020
14:44:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809247
Page 129 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-28-2020
14:44:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020
14:44:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809248
Page 130 of 322
***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: 11461152 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-28-2020
14:45:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809249
Page 131 of 322
***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: 11461152 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-28-2020
14:45:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020
14:45:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020
14:45:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809250
Page 132 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Claudicati
on
Start Date: Jun/UNK/
2005
Ongoing: NO
End Dat
e:
Jul/UN
K/2019Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:46:16
(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
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809251
Page 133 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-28-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ClaudicationInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020
14:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/UNK/2019Initial Entry
1.b
Date Location User Value Reason
Aug-28-2020
14:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae3ec6\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-2021-5683-0809252
Page 134 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Medical
History T
erm:Chronic cou
gh (smokers
cough)
Start Dat
e:Dec/UNK/2
019
Ongoing: YES
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809253
Page 135 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Chronic cough (smo
kers cough)Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020
14:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020
14:46:42
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec6\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-2021-5683-0809254
Page 136 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-28-2020
14:47:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Myocardial
Infarction
Start Date
:Jul/10/201
0
Ongoing: NO
End Date:
Jul/13/2
010Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809255
Page 137 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:47:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:47:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Myocardial Infarctio
nInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020
14:47:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jul/10/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020
14:47:13
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NO
End Date:Initial Entry
090177e196ae3ec6\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-2021-5683-0809256
Page 138 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada) Jul/13/2010
1.d
Date Location User Value Reason
Aug-28-2020
14:47:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Bradycar
dia
Start Date: Jul/UNK
/2010
Ongoing: NO
End Da
te:
Jul/13
/2010Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809257
Page 139 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:47:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:47:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BradycardiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020
14:47:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020
14:47:49
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NO
End Date:Initial Entry
090177e196ae3ec6\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-2021-5683-0809258
Page 140 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada) Jul/13/2010
1.e
Date Location User Value Reason
Aug-28-2020
14:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Lung Can
cer
Start Date: Dec/UNK
/2017
Ongoing: NO
End Dat
e:
Dec/2
8/2017Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809259
Page 141 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020
14:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
14:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Lung CancerInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020
14:48:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020
14:48:18
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NO
End Date:Initial Entry
090177e196ae3ec6\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-2021-5683-0809260
Page 142 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada) Dec/28/2017
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809261
Page 143 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
144.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3ec6\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-2021-5683-0809262
Page 144 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21.3Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.9Initial Entry
090177e196ae3ec6\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-2021-5683-0809263
Page 145 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ec6\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-2021-5683-0809264
Page 146 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020
14:48:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809265
Page 147 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020
14:49:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020
14:49:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
244831Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809266
Page 148 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
14:49:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
14:49:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
15:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
14:49:27
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809267
Page 149 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) are entered.
Please review
and correct as
appropriate.
Aug-28-2020
14:49:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
15:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP199
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
15:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP199ZInitial Entry
5.b
Date Location User Value Reason
090177e196ae3ec6\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-2021-5683-0809268
Page 150 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-28-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP19B
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
15:29:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP19B0Initial Entry
5.c
Date Location User Value Reason
Aug-28-2020
15:29:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP19B
1Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
15:29:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP19B1Initial Entry
090177e196ae3ec6\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-2021-5683-0809269
Page 151 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d
Date Location User Value Reason
Aug-28-2020
15:29:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPHCY
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
15:29:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPHCYBInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
15:29:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPHCY
CInitial Entry
090177e196ae3ec6\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-2021-5683-0809270
Page 152 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
15:29:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPHCYCInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809271
Page 153 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
14:49:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
14:49:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
15:29:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
14:49:39
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809272
Page 154 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) are entered.
Please review
and correct as
appropriate.
Aug-28-2020
14:49:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
15:29:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP199
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
15:29:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP199WInitial Entry
090177e196ae3ec6\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-2021-5683-0809273
Page 155 of 322
***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: 11461152 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-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809274
Page 156 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 13:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
14:49:56
(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-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809275
Page 157 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-28-2020
14:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809276
Page 158 of 322
***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: 11461152 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-28-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809277
Page 159 of 322
***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: 11461152 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-16-2020
12:56:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809278
Page 160 of 322
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
12:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020
12:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.7
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
12:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3ec6\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-2021-5683-0809279
Page 161 of 322
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature:
Date Location User Value Reason
Sep-16-2020
12:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020
12:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
12:56:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec6\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-2021-5683-0809280
Page 162 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
12:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
12:57:01
(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-17-2020
08:49:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-17-2020
04:28:42
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809281
Page 163 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) are entered.
Please review
and correct as
appropriate.
Sep-16-2020
12:57:01
(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-16-2020
12:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
08:49:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9C88Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ec6\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-2021-5683-0809282
Page 164 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
08:49:25
(UTC-05:00)
Eastern Time (US
& Canada)BP9C88
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809283
Page 165 of 322
***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: 11461152 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-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809284
Page 166 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 12:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020
12:57:20
(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-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809285
Page 167 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-16-2020
12:57:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809286
Page 168 of 322
***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: 11461152 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-14-2020
12:04:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809287
Page 169 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
12:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
12:05:04
(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
10:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-15-2020
04:33:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809288
Page 170 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) are entered.
Please review
and correct as
appropriate.
Oct-14-2020
12:05:04
(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-14-2020
12:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
10:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTWW
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ec6\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-2021-5683-0809289
Page 171 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10:39:16
(UTC-05:00)
Eastern Time (US
& Canada)BRTWWS
5.b
Date Location User Value Reason
Oct-15-2020
10:39:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTWW
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
10:39:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTWWTInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020
10:40:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW22FInitial Entry
090177e196ae3ec6\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-2021-5683-0809290
Page 172 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
10:40:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPW22FInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809291
Page 173 of 322
***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: 11461152 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-10-2021
13:37:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/10/2021Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809292
Page 174 of 322
***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: 11461152 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
14:29:46
(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
14:29:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021
14:30:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
14:29:46
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809293
Page 175 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) entered. Please
review and
correct as
appropriate.
Mar-10-2021
14:29:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021
14:30:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR49S6Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021
14:30:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR49S6Initial Entry
5.b
Date Location User Value Reason
Mar-10-2021 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ec6\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-2021-5683-0809294
Page 176 of 322
***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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14:30:35
(UTC-05:00)
Eastern Time (US
& Canada)Sample ID
:BS1YH
V
5.b Sample ID
Date Location User Value Reason
Mar-10-2021
14:30:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS1YHVInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021
14:30:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS1YHRInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-10-2021
14:30:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS1YHRInitial Entry
090177e196ae3ec6\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-2021-5683-0809295
Page 177 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11461152 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-19-2021
00:19:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-18-2021
23:28:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Feb-18-2021
16:05:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answere
ddocumented
Feb-18-2021
16:05:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
ddocumented.
Feb-09-2021
15:02:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
090177e196ae3ec6\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-2021-5683-0809296
Page 178 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nasal Swab are
missing. Please
review and
update as
appropriate.
Feb-09-2021
10:27:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen and
Hospitalization
form' at this
visit. Thank
you.
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Feb-08-2021
15:39:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
eDate of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing.
Please review
and update as
appropriate.
Feb-08-2021
15:39:05
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eDate of Visit is
completed but
Date of
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809297
Page 179 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time
(US & Canada)Collection in
both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Feb-08-2021
15:39:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-08-2021
15:39:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809298
Page 180 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-10-2021
07:28:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/6/2021Transcription
Error
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/7/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-05-2021
14:20:07
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NO
Date of Last Symp
tom Resolved:New
Information
090177e196ae3ec6\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-2021-5683-0809299
Page 181 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
Feb/12/2021
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec6\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-2021-5683-0809300
Page 182 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
4.b
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec6\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-2021-5683-0809301
Page 183 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.c
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Symp
tom
Prese
nt:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
090177e196ae3ec6\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-2021-5683-0809302
Page 184 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASEDInitial Entry
090177e196ae3ec6\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-2021-5683-0809303
Page 185 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) MUSCLE P
AIN
Sympt
om Pr
esent:NO
4.e Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELLInitial Entry
090177e196ae3ec6\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-2021-5683-0809304
Page 186 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sympt
om Pr
esent:NO
4.f Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED
SORE THR
OATInitial Entry
090177e196ae3ec6\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-2021-5683-0809305
Page 187 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Symp
tom P
resent
:NO
4.g Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae3ec6\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-2021-5683-0809306
Page 188 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.h Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:VOMI
TING
Symptom
Present:NOInitial Entry
090177e196ae3ec6\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-2021-5683-0809307
Page 189 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i Symptoms:
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-08-2021
15:40:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809308
Page 190 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3ec6\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-2021-5683-0809309
Page 191 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ec6\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-2021-5683-0809310
Page 192 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8. Comments/Findings/Details:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-18-2021
16:05:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809311
Page 193 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-09-2021
19:54:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021
19:54:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
11:14:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-09-2021
19:54:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample
Collected?' is
marked as No
and 'If no
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809312
Page 194 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) sample was
collected or
sample was
not collected
according to
protocol,
please provide
reason' is
missing.
Please review
and update as
appropriate.
Feb-09-2021
19:54:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Feb-19-2021
08:05:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-18-2021
15:41:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered every effort
will be made to
have the
patient self
swab if
released from
090177e196ae3ec6\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-2021-5683-0809313
Page 195 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
the hospital
and able to
swab within 4
days of
symptom
resolution.
Feb-15-2021
11:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clin: Please
make every
effort to collect
swab which
may be
collected at the
latest 4 days
after symptom
resolution as
per Protocol
Section 8.13.
Feb-12-2021
11:24:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-12-2021
11:24:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Patient was in the hos
pital at time of telehe
alth call.Changed
Information
Feb-10-2021
11:14:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text
has either a
carriage return
(line break) or
extra spaces at
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809314
Page 196 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
the end of the
text or between
words. Please
correct by
removing all
data in the
field and
re-enter
without adding
extra spaces or
using enter or
tab keys.
Feb-10-2021
11:14:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Patient was in the hos
pital at time of telehe
alth call.Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809315
Page 197 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021
11:25:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021
11:25:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021
11:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed data updated
Mar-11-2021
07:45:53
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 3: Answere
dChanged data
per query
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809316
Page 198 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
Mar-10-2021
10:44:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued
:Openedplease record
this reason in
#4 on this form.
Mar-10-2021
07:24:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dsubject was in
the hospital so
date of
collection was
beyond 4 day
window
Mar-08-2021
23:31:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued
:OpenedDM:Date of
Collection is
more than 4
days after Date
of Last
Symptom
Resolved on the
SOD form in
the same visit.
Thus, Please
review and
provide the
reason for delay
in "If no sample
was collected or
sample was not
collected ..."
field. Else,
clarify.
Mar-08-2021 ACV0PFEINFP6000 Query 3: Answere subject was in
090177e196ae3ec6\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-2021-5683-0809317
Page 199 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
20:40:24
(UTC-05:00)
Eastern Time (US
& Canada)d the hospital so
date of
collection was
beyond 4 day
window
Mar-05-2021
14:20:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Date of
Collection is
more than 4
days after Date
of Last
Symptom
Resolved on the
Signs and
Symptoms form
in the same
visit. Please
review and
update as
appropriate.
Mar-04-2021
11:33:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-04-2021
11:21:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Mar-04-2021
11:20:57
(UTC-05:00)ACV0PFEINFP6000 Query 1: Answere
dswab performed
on patient
following
090177e196ae3ec6\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-2021-5683-0809318
Page 200 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)hospitalization
on site so date
of collection is
different from
date telephone
visit was
performed.
Mar-04-2021
08:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Mar-04-2021
08:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of
Collection
25/Feb/2021 is
different from
Date of Visit
08/Feb/2021.
Please review
and update as
appropriate,
else clarify.
Mar-04-2021
08:54:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Feb/25/2021New
Information
Feb-12-2021 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809319
Page 201 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11:25:06
(UTC-05:00)
Eastern Time (US
& Canada)NO
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Mar-11-2021
07:44:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Subject was in hospit
al so was not able to s
elf swabInitial Entry
Mar-04-2021
11:21:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: New
Information
Feb-12-2021
11:25:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
subject hospitalized.Initial Entry
5.a
Date Location User Value Reason
Mar-04-2021
11:21:58
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Sample ID
:BRR4W
5Initial Entry
090177e196ae3ec6\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-2021-5683-0809320
Page 202 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
5.a Sample ID
Date Location User Value Reason
Mar-04-2021
11:21:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRR4W5Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809321
Page 203 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence
of Visits or C
ontacts:NOInitial Entry
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence
of Visits or C
ontacts:Initial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
090177e196ae3ec6\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-2021-5683-0809322
Page 204 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMER
GENC
Y ROO
M
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMER
GENC
Y ROO
M
Occurrenc
e of Visits
or Contact
s:Initial Entry
090177e196ae3ec6\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-2021-5683-0809323
Page 205 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visi
ts or Con
tacts:NOInitial Entry
Feb-08-2021
15:49:24ACV0PFEINFP6000 Data Entry:
Type of P PRIMARInitial Entry
090177e196ae3ec6\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-2021-5683-0809324
Page 206 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)ractitione
r:Y CARE
PHYSICI
AN
Occurren
ce of Visi
ts or Con
tacts:
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE P
HYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:URGE
NT CInitial Entry
090177e196ae3ec6\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-2021-5683-0809325
Page 207 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)ARE
Occurrence
of Visits or
Contacts:NO
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:Initial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
090177e196ae3ec6\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-2021-5683-0809326
Page 208 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of
Practitio
ner:TELEPH
ONE CO
NSULTAT
ION
Occurre
nce of Vi
sits or C
ontacts:YES
Number
of Visits
or Conta
cts:
1Initial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or
Contacts:
1Initial Entry
090177e196ae3ec6\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-2021-5683-0809327
Page 209 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:OT
HE
R
Occurrence of
Visits or Cont
acts:NOInitial Entry
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:OT
HE
R
Occurrence of
Visits or Cont
acts:Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809328
Page 210 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-08-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-12-2021
15:03:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-12-2021
10:19:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Changed data
per query
090177e196ae3ec6\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-2021-5683-0809329
Page 211 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-12-2021
09:09:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:
OpenedClin: Please
complete LAB
CHEM and
VITALS COV
CRFs.
Mar-11-2021
07:52:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Changed data
per query
Mar-10-2021
09:22:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:
OpenedClin: Please
complete LAB
CHEM,
VITALS COV,
PULSE OX,
OXYGEN,
VASOPRESS,
and IMAGING
CRFs, as
applicable.
Mar-10-2021
07:18:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Mar-10-2021
07:18:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Has the subject b
een in intensive c
are due to potenti
al COVID-19 illn
ess?Transcription
Error
090177e196ae3ec6\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-2021-5683-0809330
Page 212 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Mar-03-2021
17:03:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clin: As subject
was
hospitalized,
please complete
RESP TX, ILL
SEVERE, LAB
CHEM, LAB
HEM, VITALS
COV, PULSE
OX, OXYGEN,
VASOPRESS,
and IMAGING
CRFs, as
applicable.
Feb-19-2021
08:04:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-18-2021
15:41:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered will update
once medical
records are
received.
Feb-15-2021
11:23:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clin: As subject
was
hospitalized,
please complete
HOSP, RESP
TX, ILL
090177e196ae3ec6\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-2021-5683-0809331
Page 213 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
SEVERE, LAB
CHEM, LAB
HEM, VITALS
COV, PULSE
OX, OXYGEN,
VASOPRESS,
and IMAGING
CRFs, as
applicable.
Feb-08-2021
15:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Has the subject b
een in intensive c
are due to potenti
al COVID-19 illn
ess?
YESInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809332
Page 214 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-09-2021
19:55:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809333
Page 215 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-09-2021
19:55:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION S
TATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Mar-10-2021
09:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-10-2021
07:21:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Subject was not
in ICU,
Transcription
error
Mar-03-2021
17:06:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clin: Please
enter separate
record for ICU
as per CRF CRs
Section 8.36.1.
Feb-19-2021
08:04:37
(UTC-05:00)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae3ec6\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-2021-5683-0809334
Page 216 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
Feb-18-2021
15:42:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Will enter ICU
information
once records are
obtained.
Feb-18-2021
14:57:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedClin: Please
enter 2 separate
records, 1 for
hospital and 1
for ICU. Please
refer to CRF
CRs Section
8.36.1 for
details.
Feb-18-2021
11:25:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-18-2021
11:25:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HOSPITALTranscription
Error
Feb-15-2021
11:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clin: Per CRF
CRs Section
8.36.1, please
click New to
report the
090177e196ae3ec6\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-2021-5683-0809335
Page 217 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
duration of
hospitalization
by selecting
HOSPITAL
(should be the
total hospital
stay including
ICU).
Feb-09-2021
19:55:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ICUInitial Entry
3. Admission Date:
Date Location User Value Reason
Mar-10-2021
07:20:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/6/2021Transcription
Error
Feb-09-2021
19:55:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/7/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Mar-09-2021 ACV0PFEINFP6000 Query 1: Closed Response
090177e196ae3ec6\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-2021-5683-0809336
Page 218 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
12:03:15
(UTC-05:00)
Eastern Time (US
& Canada)satisfies query
Mar-09-2021
10:27:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
Mar-09-2021
10:27:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Feb/12/2021New
Information
Mar-03-2021
17:04:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clin: Please
record end
date.
Feb-09-2021
19:55:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec6\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-2021-5683-0809337
Page 219 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: RESPIRATORY TREATMENT - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809338
Page 220 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. What is the treatment Identifier?
Date Location User Value Reason
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
YESInitial Entry
3. Treatment:
Date Location User Value Reason
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HIGH FLOW OXYG
EN THERAPYInitial Entry
4. Treatment:
Date Location User Value Reason
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809339
Page 221 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HIGH FLOW OXYGE
N THERAPYInitial Entry
5. Start Date:
Date Location User Value Reason
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
6. Ongoing?
Date Location User Value Reason
Mar-09-2021
10:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/9/2021Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809340
Page 222 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-08-2021
15:47:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-1
9 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-08-2021
15:47:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021
15:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-08-2021
15:50:01
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
2Transcription
Error
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809341
Page 223 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
Feb-08-2021
15:47:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Please enter
worst toxicity
grade (1 to 5)
as it relates to
reported
symptom(s) on
Signs and
Symptoms
CRF. Please
review and
update as
appropriate.
Feb-08-2021
15:47:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
0Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809342
Page 224 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Audit Trail
Form Version: 21-Aug-2020 02:49 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809343
Page 225 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
CLINICAL CHEMIST
RYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809344
Page 226 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-
Defined I
dentifier:
Test:: C Reactiv
e Protein_
PX329
Result::
Not Done:
:
Lab Norm
al Range:Initial Entry
5.a Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
C Reactive Protein_P
X329Initial Entry
5.b
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-
Defined I
dentifier:Initial Entry
090177e196ae3ec6\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-2021-5683-0809345
Page 227 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Test:: Alanine A
minotransf
erase_PX3
0
Result::
Not Done
::
Lab Nor
mal Ran
ge:
5.b Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Alanine Aminotransfe
rase_PX30Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-
Defined I
dentifier:
Test:: Aspartate
Aminotran
sferase_PX
28
Result::Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809346
Page 228 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Not Don
e::
Lab Nor
mal Ran
ge:
5.c Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aspartate Aminotransf
erase_PX28Initial Entry
5.d
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-
Defined I
dentifier:
Test:: Alkaline
Phosphata
se_PX35
Result::
Not Done:
:
Lab Nor
mal Rang
e:Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809347
Page 229 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Alkaline Phosphatase_
PX35Initial Entry
5.e
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:
Test:: Bilirubi
n_PX2
1
Result::
Not Done::
Lab Normal
Range:Initial Entry
5.e Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Bilirubin_PX21Initial Entry
090177e196ae3ec6\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-2021-5683-0809348
Page 230 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.f
Date Location User Value Reason
Mar-12-2021
10:19:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-
Defined
Identifie
r:47
Test:: Blood Ur
ea Nitrog
en_PX47
Result:: 19
Not Don
e::
Lab Nor
mal Ran
ge:Low
7
High
20
Unit
mg/dLTranscription
Error
Mar-12-2021
10:18:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-
Defined
Identifie
r:47
Test:: Blood Ur
ea Nitrog
en_PX47
Result:: 19Transcription
Error
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809349
Page 231 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Not Don
e::
Lab Nor
mal Ran
ge:Low
.9
High
1.3
Unit
mg/L
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:47
Test:: Blood Ur
ea Nitrog
en_PX47
Result:: 19
Not Don
e::
Lab Nor
mal Ran
ge:Unit
mg/LInitial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809350
Page 232 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.f Sponsor ID:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Blood Urea Nitrogen_
PX47Initial Entry
5.f Result:
Date Location User Value Reason
Mar-12-2021
10:18:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is
present, but
lab normal
range (Low,
high or Unit)
is missing.
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809351
Page 233 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Please correct
or confirm.
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
19Initial Entry
5.f LNMT
Date Location User Value Reason
Mar-12-2021
10:19:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Low
7
High
20
Unit
mg/dLTranscription
Error
Mar-12-2021
10:18:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Low
.9
High
1.3
Unit
mg/LTranscription
Error
Mar-12-2021
10:16:34
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Unit
mg/LInitial Entry
090177e196ae3ec6\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-2021-5683-0809352
Page 234 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
5.g
Date Location User Value Reason
Mar-12-2021
10:18:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-D
efined Ide
ntifier:48
Test:: Creatini
ne_PX4
8
Result:: .62
Not Done::
Lab Norm
al Range:Low
.9
High
1.3
Unit
mg/dLTranscription
Error
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:48
Test:: Creatini
ne_PX4
8
Result:: .62
Not Done::Initial Entry
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809353
Page 235 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Norm
al Range:Unit
mg/dL
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809354
Page 236 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.g Sponsor ID:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Mar-12-2021
10:18:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-12-2021
10:16:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Result is
present, but
lab normal
range (Low,
high or Unit)
is missing.
090177e196ae3ec6\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809355
Page 237 of 322
***Confidential***
Header Text: c4591001
Visit: POT_COVID
…[truncated]