Document text
Page 1 of 261
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810569
Page 2 of 261
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
Oct/21/2020
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810570
Page 3 of 261
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11461302]
2.Birth Date: /1974
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:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810571
Page 4 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810572
Page 5 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810573
Page 6 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810574
Page 7 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 11461302 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:[Post traumatic stress disorder]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High cholesterol]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Morphine Allergy]
Start Date: UNK/UNK/1999
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 diabetes mellitus]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810575
Page 8 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810576
Page 9 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
2.Weight: [305.4]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [41.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810577
Page 10 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810578
Page 11 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/21/2020
2.Randomization Number: [400180]
3.Randomization Group: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810579
Page 12 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTX17]
5.bSample ID [BPW264]
5.cSample ID [BRTX16]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810580
Page 13 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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:
Oct/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW263]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810581
Page 14 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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: Oct/21/2020 12:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810582
Page 15 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810583
Page 16 of 261
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810584
Page 17 of 261
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810585
Page 18 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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:
Nov/10/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRC096]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810586
Page 19 of 261
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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: Nov/10/2020 11:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810587
Page 20 of 261
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810588
Page 21 of 261
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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:
Dec/9/2020
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 [BRC0GH]
5.bSample ID [BSMWGW]
5.cSample ID [BSMWGX]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810589
Page 22 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810590
Page 23 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/2/2021
2.Date of First Symptom Started: Jan/1/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/20/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810591
Page 24 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.aSymptoms - Other Text: [Headache]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810592
Page 25 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/8/2021 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810593
Page 26 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/8/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810594
Page 27 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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:[The patient was asymptomatic on 02 Feb 2021.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810595
Page 28 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[The patient was hospitalized for 5 days during which we were not able to reach him.
on 2 Feb 2021 the patient was asymptomatic.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810596
Page 29 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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: YES
Number of Visits or Contacts:
[2]
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
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]
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
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810597
Page 30 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Jan/14/2021 NO
Discharge Date:
Jan/20/2021
Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810598
Page 31 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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: Jan/14/2021
4.Ongoing? NO
Discharge Date:
Jan/20/2021
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810599
Page 32 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment
IdentifierCon Non-Drug Treat
ments Pre-specifiedTreatment TreatmentStart
DateForm Instan
ce
1.1 YES NON-INVASIVE POSITIVE P
RESSURE VENTILATION NON-INVASIVE POSITIVE P
RESSURE VENTILATION Jan/14/
2021 Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810600
Page 33 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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: NON-INVASIVE POSITIVE PRESSURE VENTILATION
4.Treatment: [NON-INVASIVE POSITIVE PRESSURE VENTILATION]
5.Start Date: Jan/14/2021
6.Ongoing? NO
End Date:
Jan/20/2021
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810601
Page 34 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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?YES
Respiratory Illness Diagnosis:
[COVID 19 Viral Infection]
Date of Diagnosis:
Jan/8/2021
3.Toxicity Grade: 2
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810602
Page 35 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810603
Page 36 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810604
Page 37 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for L
ab TestVendor NameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
1.CLINICAL CH
EMISTRY Christ Hospital L
aboratories
176 Palisade Ave
nue
Jersey City, 0730
6 Jan/14/20
21 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
329 C Reactive Protein_
PX329 34
30 Alanine Aminotransf
erase_PX30 67
28 Aspartate Aminotran
sferase_PX28 44
35 Alkaline Phosphatas
e_PX35 69
21 Bilirubin_PX21 0.6
47 Blood Urea Nitrogen
_PX47 13
48 Creatinine_PX48 0.8 Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810605
Page 38 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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 [Christ Hospital Laboratories
176 Palisade Avenue
Jersey City, 07306]
3.Collection Date: Jan/14/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [34]
Not Done:
LNMT Low
[0.0]
High
[9.9]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [67]
Not Done:
LNMT Low
[21]
High
[72]
Unit
U/L
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810606
Page 39 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [44]
Not Done:
LNMT Low
[17]
High
[59]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [69]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810607
Page 40 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[9]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.8]
Not Done:
LNMT Low
[0.8]
High
[1.5]
Unit
mg/dL
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810608
Page 41 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.HEMATOLOG
Y Christ Hospital La
boratories Jan/14/202
1 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
1 Hemoglobin_
PX1 12.6
2 Hematocrit_P
X2 38.2
3 Erythrocytes_
PX3 [ ]
5 Platelets_PX5 228
7 Leukocytes_P
X7 [ ]
608 Neutrophils_P
X608 4.7
609 Eosinophils_P
X609 0.0
612 Monocytes_P
X612 0.9
610 Basophils_PX
610 0.4
611 Lymphocytes_
PX611 19.4 Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810609
Page 42 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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 [Christ Hospital Laboratories]
3.Collection Date: Jan/14/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.6]
Not Done:
LNMT Low
[12]
High
[18]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38.2]
Not Done:
LNMT Low
[35]
High
[51]
Unit
%
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810610
Page 43 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [228]
Not Done:
LNMT Low
[130]
High
[400]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810611
Page 44 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.7]
Not Done:
LNMT Low
[1.8]
High
[7.0]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.7]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.9]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
/uL
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810612
Page 45 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.4]
Not Done:
LNMT Low
[0.0]
High
[2.0]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [19.4]
Not Done:
LNMT Low
[20]
High
[40]
Unit
%
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810613
Page 46 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810614
Page 47 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810615
Page 48 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
1.Jan/14/2021 Record Identifier: Oxygen Saturation
1 94.0 Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810616
Page 49 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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: Jan/14/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810617
Page 50 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810618
Page 51 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810619
Page 52 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810620
Page 53 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810621
Page 54 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessm
entLocation of Assessm
entImaging Meth
odOverall Assessment Form Instance
1.Jan/14/2021 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Bilateral patch interstitial and ground-glass in
filtrates.
Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810622
Page 55 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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: Jan/14/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Bilateral patch interstitial and ground-glass infiltrates.]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810623
Page 56 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/23/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810624
Page 57 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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:
Feb/23/2021
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 [BSDZXN]
5.bSample ID [BSDZXJ]
5.cSample ID [BRR4VN]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810625
Page 58 of 261
***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: 11461302 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:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810626
Page 59 of 261
***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: 11461302 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 [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810627
Page 60 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Injection site pain, left
arm Nov/10/2020 21:00 NO
End Date Time:
Nov/11/2020 07:00
Repeating
Pages
2.ADVERSE EVE
NT 2 COVID-19 Jan/14/2021 UNK:
UNK NO
End Date Time:
Jan/20/2021 UNK:UNK
Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810628
Page 61 of 261
***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: 11461302 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)[Injection site pain, left arm]
4.Start Date Time: Nov/10/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/11/2020 07:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810629
Page 62 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810630
Page 63 of 261
***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: 11461302 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)[COVID-19]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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:
[COVID + Hospitalization]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810631
Page 64 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021156254]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810632
Page 65 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810633
Page 66 of 261
***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: 11461302 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[ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810634
Page 67 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810635
Page 68 of 261
***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: 11461302 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: //
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810636
Page 69 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810637
Page 70 of 261
***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: 11461302 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?
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810638
Page 71 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810639
Page 72 of 261
***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: 11461302 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?
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810640
Page 73 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810641
Page 74 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810642
Page 75 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810643
Page 76 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810644
Page 77 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810645
Page 78 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810646
Page 79 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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?
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810647
Page 80 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810648
Page 81 of 261
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810649
Page 82 of 261
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810650
Page 83 of 261
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810651
Page 84 of 261
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 11461302 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 per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810652
Page 85 of 261
***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: 11461302 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: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810653
Page 86 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810654
Page 87 of 261
***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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810655
Page 88 of 261
***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: 11461302 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: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810656
Page 89 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810657
Page 90 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/23/2021
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810658
Page 91 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810659
Page 92 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/23/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810660
Page 93 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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:
Feb/23/2021
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 [BSDZXH]
5.bSample ID [BSDZXM]
5.cSample ID [BRR4VM]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810661
Page 94 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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/23/2021
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 [BRR4VK]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810662
Page 95 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/23/2021 12:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810663
Page 96 of 261
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810664
Page 97 of 261
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 11461302 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 [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810665
Page 98 of 261
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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?
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810666
Page 99 of 261
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810667
Page 100 of 261
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810668
Page 101 of 261
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810669
Page 102 of 261
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810670
Page 103 of 261
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810671
Page 104 of 261
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810672
Page 105 of 261
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810673
Page 106 of 261
***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: 11461302 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 Dec/9/2020
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810674
Page 107 of 261
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810675
Page 108 of 261
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810676
Page 109 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormOct-21-2020 11:53:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810677
Page 110 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormOct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810678
Page 111 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Oct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810679
Page 112 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Oct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810680
Page 113 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Oct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810681
Page 114 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Oct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810682
Page 115 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Oct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810683
Page 116 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810684
Page 117 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810685
Page 118 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-21-2020 12:02:56 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810686
Page 119 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-03-2021 11:21:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810687
Page 120 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-03-2021 11:21:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810688
Page 121 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-03-2021 11:21:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Feb-02-2021 20:34:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810689
Page 122 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-03-2021 11:21:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810690
Page 123 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-03-2021 11:21:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810691
Page 124 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-18-2021 15:49:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810692
Page 125 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-18-2021 15:49:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810693
Page 126 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-18-2021 15:49:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810694
Page 127 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-18-2021 15:49:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810695
Page 128 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810696
Page 129 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810697
Page 130 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810698
Page 131 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810699
Page 132 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810700
Page 133 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810701
Page 134 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Feb-18-2021 15:49:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810702
Page 135 of 261
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
- Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-23-2021 14:13:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810703
Page 136 of 261
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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-02-2021 13:51:19 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Falcone Approved Jan-21-2021 08:33:02 (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.
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810704
Page 137 of 261
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
Oct-21-2020 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-21-2020 11:52:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810705
Page 138 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020 11:52:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/21/2020Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810706
Page 139 of 261
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-21-2020 11:52:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11461302Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020 11:52:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-23-2020
01:04:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Close
dResponse
satisfies query
Oct-22-2020
17:19:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Oct-22-2020
17:19:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALETranscription
Error
Oct-22-2020
14:48:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1: Open
edAs per Impala,
Sex is recorded
as Male. Please
review and
update as
appropriate.
Oct-21-2020
11:53:04
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810707
Page 140 of 261
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time
(US & Canada)
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020 11:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-21-2020 11:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810708
Page 141 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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-21-2020 11:53:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810709
Page 142 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-21-2020 11:53:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 11:53:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 11:53:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810710
Page 143 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020 11:54:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Post traumatic stres
s disorder
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020 11:54:08
(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
Oct-21-2020 11:54:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Post traumatic stress disorderInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-21-2020 11:54:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-21-2020 11:54:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810711
Page 144 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 11:59:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-21-2020 11:59:44
(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
Oct-21-2020 11:59:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-21-2020 11:59:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-21-2020 11:59:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-21-2020 12:00:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:High cholester
ol
Start Date: UNK/UNK/20
19Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810712
Page 145 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-21-2020 12:00:10
(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
Oct-21-2020 12:00:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
High cholesterolInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-21-2020 12:00:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-21-2020 12:00:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-21-2020 12:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Morphine Aller
gy
Start Date: UNK/UNK/199
9
Ongoing: YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810713
Page 146 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Oct-21-2020 12:00:30
(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
Feb-19-2021 11:31:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-18-2021 15:59:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered form updated.
Feb-17-2021 06:02:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Clinical_ Per report,
subject has additional
MedHx of Diabetes
mellitus. Please
revise and update
form accordingly.
Thanks
Oct-21-2020 12:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Morphine AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-21-2020 12:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-21-2020 12:00:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Feb-18-2021 16:00:24 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810714
Page 147 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) Line/MH Numbe
r:5
Medical History
Term:Type 2 diabetes m
ellitus
Start Date: UNK/UNK/2010
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Feb-18-2021 16:00:24
(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
Feb-18-2021 16:00:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type 2 diabetes mellitusInitial Entry
1.e Start Date:
Date Location User Value Reason
Feb-18-2021 16:00:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Feb-18-2021 16:00:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810715
Page 148 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020 12:01:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810716
Page 149 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-24-2020 07:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 1: Closed Response satisfies
query
Oct-23-2020 17:08:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered not clinically
significant
Oct-22-2020 07:55:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Please review
and confirm if the
weight value is
clinically significant
in the opinion of PI.
Thanks
Oct-21-2020 12:04:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 305.4 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for lb.
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
305.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810717
Page 150 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
41.4Initial Entry
7.a
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810718
Page 151 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020 12:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810719
Page 152 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Iden
tifier:Not Applica
ble
Test:: Not Applica
bleInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810720
Page 153 of 261
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-21-2020 12:02:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810721
Page 154 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020 12:03:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Oct-22-2020
11:01:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_07
Oct-22-2020
07:08:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Oct-22-2020
07:08:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
40018
0Transcription Error
Oct-22-2020
01:53:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5123190;Randomization
Number 400182 appears to be
a duplicate with Subject
11701398. Please confirm the
number has been entered
correctly or clarify.
Oct-21-2020
12:16:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
40018
2Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810722
Page 155 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 12:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 12:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 14:43:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 12:04:17
(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-21-2020 12:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 14:43:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTX17Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810723
Page 156 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:43:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRTX17Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020 14:44:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW264Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 14:44:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPW264Initial Entry
5.c
Date Location User Value Reason
Oct-21-2020 14:44:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTX16Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 14:44:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRTX16Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810724
Page 157 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 12:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 12:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 14:44:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 12:04:30
(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-21-2020 12:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 14:44:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW263Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810725
Page 158 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020 14:44:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPW263Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810726
Page 159 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020 12:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810727
Page 160 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-21-2020 12:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810728
Page 161 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
Oct-21-2020 12:03:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810729
Page 162 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 12:52:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810730
Page 163 of 261
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Nov-10-2020 12:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2.a
Date Location User Value Reason
Nov-10-2020 12:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-10-2020 12:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-10-2020 12:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-10-2020 12:53:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-10-2020 12:53:04
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810731
Page 164 of 261
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810732
Page 165 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 11:32:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 11:32:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 11:32:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020 11:32:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRC096Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 11:32:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRC096Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810733
Page 166 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020 11:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810734
Page 167 of 261
***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, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-10-2020 12:53:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810735
Page 168 of 261
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-09-2020 12:33:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810736
Page 169 of 261
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020 11:52:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 11:52:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020 11:52:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 11:52:16
(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.
Dec-09-2020 11:52:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020 11:52:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRC0GHInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-09-2020 11:52:29 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810737
Page 170 of 261
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern Time
(US & Canada)BRC0GH
5.b
Date Location User Value Reason
Dec-09-2020 11:52:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMWGWInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-09-2020 11:52:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSMWGWInitial Entry
5.c
Date Location User Value Reason
Dec-09-2020 11:53:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMWGXTranscription Error
Dec-09-2020 11:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMWGXDInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-09-2020 11:53:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-09-2020 11:53:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSMWGXTranscription Error
Dec-09-2020 11:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as appropriate.
Dec-09-2020 11:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSMWGXDInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810738
Page 171 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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 04:51:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-18-2021 15:47:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered self swab not done.
Feb-05-2021 13:50:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-05-2021 09:44:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Deviation: Nasal
swab not collected
Feb-04-2021 07:09:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Kindly review
and complete
‘Microbiology
Specimen at this visit.
Thank you.
Feb-03-2021 06:49:49
(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
Nasal Swab are
missing. Please
review and update as
appropriate.
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-02-2021 13:51:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Feb-02-2021 13:51:17
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810739
Page 172 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Feb-02-2021 13:51:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-02-2021 13:51:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810740
Page 173 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/1/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Jan/20/2021Initial Entry
4.a
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810741
Page 174 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
4.b
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Feb-02-2021 16:06:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREAT
H
Symptom
Present:NOInitial Entry
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREAT
H
Symptom
Present:Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810742
Page 175 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.c Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNES
S OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom
Present:NOInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810743
Page 176 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.e Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE PA
INInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom
Present:YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810744
Page 177 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.g Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THR
OATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: YESInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810745
Page 178 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i Symptoms:
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-02-2021 16:06:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
Feb-07-2021 21:37:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: HeadacheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-07-2021 21:37:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810746
Page 179 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810747
Page 180 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROM
E CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
7. Test Result:
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810748
Page 181 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-16-2021 01:40:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-15-2021 20:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Feb-15-2021 20:06:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NALT UnknownChanged Information
Feb-10-2021 03:55:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM : As per CRF
CR, If trade name is
not known. Please
update NALT
Unknown in the
specified field, Thank
you.
Feb-09-2021 08:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NALT-UNKInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810749
Page 182 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-02-2021 16:14:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-02-2021 16:14:15
(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-02-2021 16:16:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-02-2021 16:14:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Feb-02-2021 16:14:15
(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-02-2021 16:17:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The patient was asymptomatic on 02
Feb 2021.Transcription Error
Feb-02-2021 16:16:54
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
The patient was asymptomatic n 02 FInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810750
Page 183 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) eb 2021.
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810751
Page 184 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-02-2021 16:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-02-2021 16:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-02-2021 16:15:23
(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-02-2021 16:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The patient was hospitalized for 5 day
s during which we were not able to rea
ch him. on 2 Feb 2021 the patient was
asymptomatic.Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810752
Page 185 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:SPECIALIST
Occurrence of Vis
its or Contacts:YES
Number of Visits
or Contacts:
2Initial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
2Initial Entry
1.b
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGENCY R
OOM
Occurrence of Vis
its or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810753
Page 186 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:PRIMARY CAR
E PHYSICIAN
Occurrence of Vis
its or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT C
AREInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810754
Page 187 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Occurrence of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 20:37:19
(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-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:TELEPHONE CO
NSULTATION
Occurrence of Vi
sits or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810755
Page 188 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f
Date Location User Value Reason
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Con
tacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 20:37:19
(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-02-2021 20:37:19
(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
Feb-22-2021 11:52:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-22-2021 10:44:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered documented VS were
not provided in the
medical records from
the hospitalization.
Feb-19-2021 08:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clin: As subject was
hospitalized, please
enter VITALS COV. If
multiple values were
recorded on a single
day, at a minimum the
most abnormal should
be recorded.
Feb-19-2021 08:06:21
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810756
Page 189 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
Feb-18-2021 15:53:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered documented with
records from hospital.
Feb-03-2021 10:35:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clin: As subject was
hospitalized, please
complete LAB
CHEM, LAB HEM,
VITALS COV,
PULSE OX,
OXYGEN,
VASOPRESS, and
IMAGING CRFs as
applicable.
Feb-02-2021 20:37:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Has the subject been in intensive ca
re due to potential COVID-19 illnes
s?
NOInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810757
Page 190 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-02-2021 20:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810758
Page 191 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-02-2021 20:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Feb-02-2021 20:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Feb-02-2021 20:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Feb-02-2021 20:38:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Jan/20/2021Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810759
Page 192 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: RESPIRATORY TREATMENT - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-02-2021 20:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810760
Page 193 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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
Feb-02-2021 20:39:36
(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
Feb-02-2021 20:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
YESInitial Entry
3. Treatment:
Date Location User Value Reason
Feb-02-2021 20:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NON-INVASIVE POSITIVE PRESS
URE VENTILATIONInitial Entry
4. Treatment:
Date Location User Value Reason
Feb-02-2021 20:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NON-INVASIVE POSITIVE PRESSU
RE VENTILATIONInitial Entry
5. Start Date:
Date Location User Value Reason
Feb-02-2021 20:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
6. Ongoing?
Date Location User Value Reason
Feb-02-2021 20:39:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/20/2021Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810761
Page 194 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 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-02-2021 20:33:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-16-2021 08:03:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-15-2021 20:07:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Feb-15-2021 20:07:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
COVID 19 Viral Infection
Date of Diagnosis:
Jan/8/2021Changed Information
Feb-09-2021 15:53:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clin: Please consider
updating date of
diagnosis to match
date of collection of
08Jan2021 of positive
local swab.
Feb-09-2021 08:22:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered On 08 Jan 2021 the
patient was
symptomatic and had
a positive COVID19
Test at a local lab.
Feb-03-2021 10:34:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clin: Diagnosis of
COVID-19 (or
similar) should only
be recorded if subject
is symptomatic and
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810762
Page 195 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: 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: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
has a positive local
swab recorded in
COVID TEST CRF.
See CRF CRs Section
8.33.3 for details.
Feb-02-2021 20:33:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-02-2021 20:33:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
COVID 19 Viral Infection
Date of Diagnosis:
Jan/14/2021Transcription Error
Feb-02-2021 20:33:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date entered is in the
future compared to
today's date. Please
correct.
Feb-02-2021 20:33:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
COVID 19 Viral Infection
Date of Diagnosis:
Feb/14/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-02-2021 20:33:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810763
Page 196 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - Audit Trail
Form Version: 17-Jul-2020 21:55 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-02-2021 20:36:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810764
Page 197 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 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-03-2021 11:21:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-03-2021 11:20:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Feb-02-2021 20:36:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE COVID-19 ILLNESSInitial Entry
2. Subcategory of Clinical Event:
Date Location User Value Reason
Feb-02-2021 20:34:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Was a diagnosis obtained?
Date Location User Value Reason
Feb-08-2021 09:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-03-2021 11:21:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-03-2021 11:20:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Feb-03-2021 11:20:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Feb-03-2021 10:37:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clin: Per CRF CRs
Section 8.34, this
CRF should only be
completed if a
participant had
significant renal,
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810765
Page 198 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
hepatic or
neurological
dysfunction as part of
their potential
COVID-19 illness. If
not, please enter
FORM LEVEL
comment of Not
Applicable.
Feb-02-2021 20:36:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Diagnosis:
COVID 19 Viral infection
Start Date:
Jan/14/2021
Ongoing?:
NO
End Date:
Jan/20/2021Initial Entry
4. Toxicity Grade:
Date Location User Value Reason
Feb-03-2021 11:21:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-03-2021 11:21:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Feb-02-2021 20:36:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810766
Page 199 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Audit
Trail
Form Version: 10-Oct-2020 15:58 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810767
Page 200 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Feb-09-2021 13:44:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-09-2021 08:42:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-09-2021 08:42:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Christ Hospital Laboratories
176 Palisade Avenue
Jersey City, 07306New Information
Feb-09-2021 04:35:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please consider
updating Lab Address
in this particular field
if available, thank
you.
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Christ Hospital LaboratoriesInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (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-2021-5683-0810768
Page 201 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
5.a
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:329
Test:: C Reactive Protei
n_PX329
Result 34
Not Done::
Lab Normal Rang
e:Low
0.0
High
9.9
Unit
mg/LInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
34Initial Entry
5.a LNMT
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810769
Page 202 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.0
High
9.9
Unit
mg/LInitial Entry
5.b
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:30
Test:: Alanine Aminotran
sferase_PX30
Result:: 67
Not Done::
Lab Normal Ra
nge:Low
21
High
72
Unit
U/LInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810770
Page 203 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
67Initial Entry
5.b LNMT
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
21
High
72
Unit
U/LInitial Entry
5.c
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:28
Test:: Aspartate Aminotra
nsferase_PX28
Result:: 44
Not Done::Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810771
Page 204 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Normal Ra
nge:Low
17
High
59
Unit
U/L
5.c Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aspartate Aminotransferase_PX28Initial Entry
5.c Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
44Initial Entry
5.c LNMT
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
17
High
59
Unit
U/LInitial Entry
5.d
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810772
Page 205 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:35
Test:: Alkaline Phosphat
ase_PX35
Result:: 69
Not Done::
Lab Normal Ran
ge:Low
38
High
126
Unit
U/LInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810773
Page 206 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
69Initial Entry
5.d LNMT
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
38
High
126
Unit
U/LInitial Entry
5.e
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ident
ifier:21
Test:: Bilirubin_PX
21
Result:: 0.6
Not Done::Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810774
Page 207 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Normal Range: Low
0.2
High
1.3
Unit
mg/dL
5.e Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
0.6Initial Entry
5.e LNMT
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.2
High
1.3
Unit
mg/dLInitial Entry
5.f
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810775
Page 208 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:47
Test:: Blood Urea Nitrog
en_PX47
Result:: 13
Not Done::
Lab Normal Ran
ge:Low
9
High
20
Unit
mg/dLInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810776
Page 209 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.f Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
5.f LNMT
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
9
High
20
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Iden
tifier:48
Test:: Creatinine_P
X48
Result:: 0.8
Not Done::Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810777
Page 210 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Normal Range: Low
0.8
High
1.5
Unit
mg/dL
5.g Sponsor ID:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
0.8Initial Entry
5.g LNMT
Date Location User Value Reason
Feb-07-2021 22:06:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.8
High
1.5
Unit
mg/dLInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810778
Page 211 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Audit
Trail
Form Version: 10-Oct-2020 16:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810779
Page 212 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Christ Hospital LaboratoriesInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:1
Test:: Hemoglobin_
PX1
Result:: 12.6
Not Done::Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810780
Page 213 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Normal Range: Low
12
High
18
Unit
g/dL
5.a Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
12.6Initial Entry
5.a LNMT
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
12
High
18
Unit
g/dLInitial Entry
5.b
Date Location User Value Reason
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810781
Page 214 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Iden
tifier:2
Test:: Hematocrit_P
X2
Result:: 38.2
Not Done::
Lab Normal Range: Low
35
High
51
Unit
%Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810782
Page 215 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
38.2Initial Entry
5.b LNMT
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
35
High
51
Unit
%Initial Entry
5.c
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:3
Test:: Erythrocytes_
PX3
Result::
Not Done:: NOT DONE
Lab Normal Range:Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810783
Page 216 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
5.c Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Erythrocytes_PX3Initial Entry
5.c Not Done:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Identi
fier:5
Test:: Platelets_P
X5
Result:: 228
Not Done::
Lab Normal Range: Low
130
High
400
Unit
/uLInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810784
Page 217 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
5.d Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Platelets_PX5Initial Entry
5.d Result:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
228Initial Entry
5.d LNMT
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
130
High
400
Unit
/uLInitial Entry
5.e
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Iden
tifier:7
Test:: Leukocytes_
PX7
Result::
Not Done:: NOT DONE
Lab Normal Range:Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810785
Page 218 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.e Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
5.e Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Leukocytes_PX7Initial Entry
5.e Not Done:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.f
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:608
Test:: Neutrophils_P
X608
Result:: 4.7
Not Done::
Lab Normal Range: Low
1.8
High
7.0
Unit
/uLInitial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810786
Page 219 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.f Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
608Initial Entry
5.f Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Neutrophils_PX608Initial Entry
5.f Result:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4.7Initial Entry
5.f LNMT
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
1.8
High
7.0
Unit
/uLInitial Entry
5.g
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:609
Test:: Eosinophils_P
X609
Result:: 0.0
Not Done::Initial Entry
090177e196ae3ec2\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810787
Page 220 of 261
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461302 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Normal Range: Low
0.0
High
0.7
Unit
/uL
5.g Sponsor ID:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
609Initial Entry
5.g Test:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Eosinophils_PX609Initial Entry
5.g Result:
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
0.0Initial Entry
5.g LNMT
Date Location User Value Reason
Feb-18-2021 15:59:18
(UTC-05:00) Eastern Time
(US
…[truncated]