Document text
Page 1 of 281
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810163
Page 2 of 281
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
Sep/14/2020
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810164
Page 3 of 281
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11461235]
2.Birth Date: /1954
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810165
Page 4 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810166
Page 5 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810167
Page 6 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810168
Page 7 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810169
Page 8 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [283.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [40.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810170
Page 9 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [259019]
3.Randomization Group: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810171
Page 10 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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:
Sep/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPHD3N]
5.bSample ID [BPHD3P]
5.cSample ID [BP9C6V]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810172
Page 11 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9C6T]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810173
Page 12 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/14/2020 13:28
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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810174
Page 13 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810175
Page 14 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810176
Page 15 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810177
Page 16 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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/5/2020
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 [BP9CFB]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810178
Page 17 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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/5/2020 10:10
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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810179
Page 18 of 281
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810180
Page 19 of 281
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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:
Nov/2/2020
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 [BRC07W]
5.bSample ID [BSMWB8]
5.cSample ID [BSMWB6]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810181
Page 20 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810182
Page 21 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/15/2020
2.Date of First Symptom Started: Dec/3/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/8/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810183
Page 22 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Symptoms - Other
5.aSymptoms - Other Text: [loss of appetite]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810184
Page 23 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/3/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810185
Page 24 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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: Dec/3/2020
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: ROCHE MOLECULAR SYSTEMS COBAS SARS-COV-2
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810186
Page 25 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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:[Subject was hospitalized then quarantined in hotel. Refused to self swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810187
Page 26 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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:[Subject was hospitalized then quarantined in hotel. Refused to self swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810188
Page 27 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810189
Page 28 of 281
***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: 11461235 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 Dec/3/2020 NO
Discharge Date:
Dec/7/2020
Repeating Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810190
Page 29 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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: Dec/3/2020
4.Ongoing? NO
Discharge Date:
Dec/7/2020
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810191
Page 30 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment
IdentifierCon Non-Drug Tre
atments Pre-specifi
edTreatment TreatmentStart
DateForm Instan
ce
1.1 YES NON-INVASIVE POSITIV
E PRESSURE VENTILATI
ON NON-INVASIVE POSITIV
E PRESSURE VENTILATI
ON Dec/3/
2020 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0810192
Page 31 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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: Dec/3/2020
6.Ongoing? NO
End Date:
Dec/7/2020
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(b) (4)
FDA-CBER-2021-5683-0810193
Page 32 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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 pneumonia]
Date of Diagnosis:
Dec/3/2020
3.Toxicity Grade: 3
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Page 33 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0810195
Page 34 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810196
Page 35 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor NameCollecti
on Date:Specim
en TypeLab ResultForm Instan
ce
1.CLINICAL C
HEMISTRY Name:
AHS
MORRISTOWN ME
DICAL CENTER LA
B
Address:
100 Madison Avenue,
Morristown, NJ 07960
Dec/3/20
20 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
329 C Reactive Protei
n_PX329 24.7
30 Alanine Aminotr
ansferase_PX30 31
28 Aspartate Amino
transferase_PX28
29
35 Alkaline Phospha
tase_PX35 66
21 Bilirubin_PX21 0.9
47 Blood Urea Nitro
gen_PX47 22
48 Creatinine_PX48
0.95
Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810197
Page 36 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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 [Name:
AHS
MORRISTOWN MEDICAL CENTER LAB
Address:
100 Madison Avenue,
Morristown, NJ 07960]
3.Collection Date: Dec/3/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [24.7]
Not Done:
LNMT Low
[0.0]
High
[9.0]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [31]
Not Done:
LNMT Low
[12]
High
[59]
Unit
U/L
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810198
Page 37 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [29]
Not Done:
LNMT Low
[15]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [66]
Not Done:
LNMT Low
[45]
High
[117]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.9]
Not Done:
LNMT Low
[0.0]
High
[1.1]
Unit
mg/dL
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810199
Page 38 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [22]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.95]
Not Done:
LNMT Low
[0.60]
High
[1.30]
Unit
mg/dL
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810200
Page 39 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor Name (DE
RIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOLO
GY AHS
Morristown Medic
al center labs Dec/13/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1 Hemoglobin
_PX1 14.6
2 Hematocrit_
PX2 44.4
3 Erythrocytes
_PX3 4.87
5 Platelets_PX
5 122
7 Leukocytes_
PX7 3.87
608 Neutrophils_
PX608 2.66
609 Eosinophils_
PX609 0.04
612 Monocytes_
PX612 0.33
610 Basophils_P
X610 0.01
611 Lymphocytes
_PX611 0.77 Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810201
Page 40 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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 [AHS
Morristown Medical center labs]
3.Collection Date: Dec/13/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.6]
Not Done:
LNMT Low
[39.0]
High
[50.0]
Unit
%
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [44.4]
Not Done:
LNMT Low
[39.0]
High
[50.0]
Unit
%
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810202
Page 41 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.87]
Not Done:
LNMT Low
[4.20]
High
[5.70]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [122]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [3.87]
Not Done:
LNMT Low
[4.5]
High
[11.00]
Unit
10^9/L
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810203
Page 42 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [2.66]
Not Done:
LNMT Low
[2.00]
High
[6.60]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.04]
Not Done:
LNMT Low
[0.00]
High
[0.20]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.33]
Not Done:
LNMT Low
[0.20]
High
[0.80]
Unit
10^9/L
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810204
Page 43 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.01]
Not Done:
LNMT Low
[0.00]
High
[0.20]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.77]
Not Done:
LNMT Low
[0.70]
High
[3.70]
Unit
10^9/L
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810205
Page 44 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
1.Dec/3/2020 Record Identifier: Systolic: Diastolic:
1 118 69 Repeating Pages
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(b) (4)
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Page 45 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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: Dec/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [118]
Diastolic: [69]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in beats/minute: [93]
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(b) (4)
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Page 46 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
1.Dec/3/2020 Record Identifier: Oxygen Saturation
1 94.0 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0810208
Page 47 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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: Dec/3/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810209
Page 48 of 281
***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: 11461235 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
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(b) (4)
FDA-CBER-2021-5683-0810210
Page 49 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
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Page 50 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810212
Page 51 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810213
Page 52 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Dec/3/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Right lower lobe pneumonia
Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0810214
Page 53 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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: Dec/3/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Right lower lobe pneumonia]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810215
Page 54 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/21/2021Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810216
Page 55 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/21/2021Form: 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: 11461235 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:
Jan/21/2021
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 [BSDZNN]
5.bSample ID [BP9CV4]
5.cSample ID [BSDZNL]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810217
Page 56 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810218
Page 57 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810219
Page 58 of 281
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810220
Page 59 of 281
***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: 11461235 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: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810221
Page 60 of 281
***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: 11461235 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:
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810222
Page 61 of 281
***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: 11461235 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 [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810223
Page 62 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810224
Page 63 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810225
Page 64 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810226
Page 65 of 281
***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: 11461235 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[ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810227
Page 66 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810228
Page 67 of 281
***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: 11461235 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: //
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810229
Page 68 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810230
Page 69 of 281
***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: 11461235 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?
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810231
Page 70 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810232
Page 71 of 281
***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: 11461235 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?
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810233
Page 72 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810234
Page 73 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810235
Page 74 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810236
Page 75 of 281
***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: 11461235 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:
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810237
Page 76 of 281
***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: 11461235 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?
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810238
Page 77 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810239
Page 78 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810240
Page 79 of 281
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810241
Page 80 of 281
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810242
Page 81 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810243
Page 82 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810244
Page 83 of 281
***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: 11461235 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: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810245
Page 84 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810246
Page 85 of 281
***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: 11461235 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
Jan/21/2021
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810247
Page 86 of 281
***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: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810248
Page 87 of 281
***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: 11461235 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
:Jan/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810249
Page 88 of 281
***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: 11461235 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:
Jan/21/2021
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 [BSDZNM]
5.bSample ID [BP9CV3]
5.cSample ID [BSDZNK]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810250
Page 89 of 281
***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: 11461235 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:
Jan/21/2021
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 [BP9CV1]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810251
Page 90 of 281
***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: 11461235 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: Jan/21/2021 08:32
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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810252
Page 91 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810253
Page 92 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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/11/2021
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 [BRR4SJ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810254
Page 93 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11461235 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/11/2021 09:39
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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810255
Page 94 of 281
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810256
Page 95 of 281
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/4/2021
3.Comments: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810257
Page 96 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810258
Page 97 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810259
Page 98 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810260
Page 99 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810261
Page 100 of 281
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810262
Page 101 of 281
***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: 11461235 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 Nov/2/2020
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810263
Page 102 of 281
***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: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810264
Page 103 of 281
***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: 11461235 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
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810265
Page 104 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-14-2020 14:48:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810266
Page 105 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-14-2020 14:49:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810267
Page 106 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormDec-10-2020 11:54:16 (UTC-05:00) Eastern
Time (US & Canada)please remove. entered in error.
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810268
Page 107 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-02-2021 15:41:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810269
Page 108 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-02-2021 15:41:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
1Feb-02-2021 15:40:34 (UTC-05:00) Eastern
Time (US & Canada)not applicable.
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810270
Page 109 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-02-2021 15:41:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
2Jan-27-2021 09:38:16 (UTC-05:00) Eastern
Time (US & Canada)Acute hypoxic respiratory failure second to
COVID 19 Infection
Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810271
Page 110 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-02-2021 15:41:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810272
Page 111 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-02-2021 15:41:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810273
Page 112 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-01-2021 14:58:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810274
Page 113 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-01-2021 14:57:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810275
Page 114 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-01-2021 14:56:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810276
Page 115 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810277
Page 116 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810278
Page 117 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810279
Page 118 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810280
Page 119 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810281
Page 120 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810282
Page 121 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Feb-01-2021 14:19:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810283
Page 122 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-21-2021 10:19:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810284
Page 123 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-27-2021 09:20:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 14:39:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-21-2021 19:52:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 16:09:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810285
Page 124 of 281
***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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
N/A Jan-21-2021 09:56:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Falcone Approved Jan-21-2021 07:55:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFalcone, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-07-2020 07:12:22 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Falcone Approved Nov-07-2020 15:56:51 (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.
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810286
Page 125 of 281
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
Sep-14-2020 14:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-14-2020 14:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810287
Page 126 of 281
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-14-2020 14:48:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/14/2020Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810288
Page 127 of 281
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-14-2020 14:47:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11461235Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-14-2020 14:47:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-14-2020 14:48:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-14-2020 14:48:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-14-2020 14:48:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ec5\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)
FDA-CBER-2021-5683-0810289
Page 128 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-14-2020 14:48:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810290
Page 129 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
Sep-14-2020 14:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-14-2020 14:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-14-2020 14:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810291
Page 130 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
283.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
40.6Initial Entry
090177e196ae3ec5\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-2021-5683-0810292
Page 131 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.5
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-14-2020 14:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec5\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-2021-5683-0810293
Page 132 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-14-2020 14:50:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-14-2020 14:50:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
259019Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810294
Page 133 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 14:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 14:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 14:59:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 14:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 14:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 14:59:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHD3NInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810295
Page 134 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 14:59:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHD3NInitial Entry
5.b
Date Location User Value Reason
Sep-14-2020 14:59:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHD3PInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-14-2020 14:59:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHD3PInitial Entry
5.c
Date Location User Value Reason
Sep-14-2020 14:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9C6VInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-14-2020 14:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9C6VInitial Entry
090177e196ae3ec5\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-2021-5683-0810296
Page 135 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 15:00:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 14:51:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 15:00:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9C6TInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810297
Page 136 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 15:00:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9C6TInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810298
Page 137 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 13:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ec5\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-2021-5683-0810299
Page 138 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-14-2020 14:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810300
Page 139 of 281
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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
Sep-14-2020 14:51:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810301
Page 140 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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-05-2020 10:42:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810302
Page 141 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-05-2020 10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2.a
Date Location User Value Reason
Oct-05-2020 10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.0
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-05-2020 10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-05-2020 10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-05-2020 10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ec5\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-2021-5683-0810303
Page 142 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature Location:
Date Location User Value Reason
Oct-05-2020 10:42:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810304
Page 143 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 10:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 10:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 10:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-05-2020 10:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-05-2020 10:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810305
Page 144 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-05-2020 10:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9CFBInitial Entry
5.a
Date Location User Value Reason
Oct-05-2020 10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9CFBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9CFBInitial Entry
090177e196ae3ec5\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-2021-5683-0810306
Page 145 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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-05-2020 10:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-05-2020 10:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-05-2020 10:43:18
(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-05-2020 10:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020 10:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-05-2020 10:43:18
(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-05-2020 10:43:18
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3ec5\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-2021-5683-0810307
Page 146 of 281
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-05-2020 10:43:18
(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-05-2020 10:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-05-2020 10:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810308
Page 147 of 281
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 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-02-2020 11:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810309
Page 148 of 281
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 11:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 11:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 13:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 11:20:44
(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.
Nov-02-2020 11:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 13:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRC07WInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810310
Page 149 of 281
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 13:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRC07WInitial Entry
5.b
Date Location User Value Reason
Nov-02-2020 13:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMWB8Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 13:48:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMWB8Initial Entry
5.c
Date Location User Value Reason
Nov-02-2020 13:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMWB6Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 13:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMWB6Initial Entry
090177e196ae3ec5\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-2021-5683-0810311
Page 150 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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-02-2021 06:33:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 10: Closed Response satisfies
query
Feb-01-2021 14:20:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 10: Answered completed.
Jan-21-2021 07:57:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 10: Opened DM: Kindly review
and complete
‘Hospitalization
Details form' at this
visit. Thank you.
Dec-21-2020 16:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 5: Closed Response satisfies
query
Dec-21-2020 16:13:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 6: Closed Response satisfies
query
Dec-21-2020 08:06:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 9: Closed Close Auto Query
Dec-21-2020 06:37:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 7: Deleted Query issued for
erroneous visit.
Dec-21-2020 01:38:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 9: Opened DM: Visit is marked
ERRONEOUS
VISIT, however data
is present on all
initiated forms. If
visit is
ERRONEOUS then
consider to clear the
data and add form
level comment by
selecting Not
090177e196ae3ec5\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) (4)
(b) (4)
FDA-CBER-2021-5683-0810312
Page 151 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Applicable option at
form level on all
initiated forms else,
clarify.
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 8: Deleted Close Auto Query
Dec-20-2020 13:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 9: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Dec-20-2020 13:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 8: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Dec-20-2020 13:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 7: Candidate 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.
Dec-20-2020 13:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Transcription Error
Dec-20-2020 13:10:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered updated
Dec-17-2020 12:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 6: Answered multiple attempts to
obtain medical
records met with no
response- details to
follow
090177e196ae3ec5\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-2021-5683-0810313
Page 152 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-14-2020 12:14:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 6: Opened Clin: It was stated in
the SAE report
#2020481495 that the
subject had a
SARS-CoV-2 NAAT
test result positive.
Please update the
MICROBIOLOGY
SPECIMEN
Dec-14-2020 12:11:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 5: Opened Medical monitor:
Despite the potential
VOVID-19 Illness
visit was not
conducted yet as
required per protocol,
ERRONEOUS VISIT
should not be entered
in this CRF form.
Please complete the
CRF forms with all
the data available
Dec-14-2020 06:38:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Deleted no other assessment
performed
Dec-14-2020 02:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Dec-11-2020 08:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered done
Dec-11-2020 08:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Dec-11-2020 03:16:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed open query to
indicate visit as
erroneous
090177e196ae3ec5\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-2021-5683-0810314
Page 153 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-11-2020 03:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed open query to
indicate visit as
erroneous
Dec-11-2020 01:48:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
response. As this visit
was entered in error
please tick the radio
button for ‘Erroneous
Visit' on this page to
indicate that the visit
entry is erroneous.
Dec-10-2020 11:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered entered in error. visit
has not occurred.
unable to delete.
Dec-10-2020 11:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered entered in error.
unable to delete.
entered in error.
Dec-10-2020 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered unable to clear date
and time of visit. date
was entered in error.
illness visit has not
occurred.
Dec-09-2020 12:12:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Kindly review
and complete ‘Health
Care Utilization,
Microbiology
Specimen, Illness
Details form' at this
visit. Thank you.
Dec-08-2020 07:57:10
(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.
Dec-08-2020 07:56:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Date of Visit is
completed but Date
of Assessment in the
Signs and Symptoms
090177e196ae3ec5\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810315
Page 154 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
form is missing.
Please review and
update as appropriate.
Dec-07-2020 10:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Changed Information
Dec-07-2020 07:12:21
(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.
Dec-07-2020 07:12:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 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.
Dec-07-2020 07:12:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Dec-21-2020 08:06:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Dec-14-2020 12:11:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Dec-14-2020 12:10:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Medical monitor:
Despite the potential
VOVID-19 Illness
visit was not
conducted yet as
required per
protocol,
090177e196ae3ec5\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-2021-5683-0810316
Page 155 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
ERRONEOUS
VISIT should not be
entered in this CRF
form. Please
complete the CRF
forms with all the
data available
Dec-11-2020 08:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-07-2020 07:12:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810317
Page 156 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Dec/8/2020Initial Entry
4.a
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae3ec5\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-2021-5683-0810318
Page 157 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(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
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3ec5\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-2021-5683-0810319
Page 158 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.c Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae3ec5\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-2021-5683-0810320
Page 159 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196ae3ec5\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-2021-5683-0810321
Page 160 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec5\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-2021-5683-0810322
Page 161 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-20-2020 13:16:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-20-2020 13:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Othe
r:loss of appetit
eInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-20-2020 13:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
loss of appetiteInitial Entry
090177e196ae3ec5\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-2021-5683-0810323
Page 162 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Dec-20-2020 13:17:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810324
Page 163 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-05-2021 04:58:37
(UTC-05:00) EasternACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3ec5\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-2021-5683-0810325
Page 164 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
Feb-04-2021 14:38:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-03-2021 14:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please remove data
from Trade Name
Other field. Please
correct
inconsistency.
Feb-03-2021 08:19:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Feb-03-2021 07:35:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Trade Name is not
Other, however
Trade Name Other,
Specify is
completed. Please
verify and correct
inconsistency.
Feb-03-2021 07:35:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ROCHE MOLECULAR SYST
EMS COBAS SARS-COV-2New Information
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-20-2020 13:17:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-05-2021
04:59:08
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 2:
ClosedResponse
satisfies query
090177e196ae3ec5\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-2021-5683-0810326
Page 165 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US &
Canada)
Feb-04-2021
14:38:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredTranscription
Error
Feb-04-2021
14:38:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:Transcription
Error
Feb-04-2021
02:06:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2:
OpenedRoche
Molecular
systems cobas
sars cov 2
appears to be
present in the
provided
Coding List of
Trade Name
field on the
CRF page,
Please choose
the same from
the list or else
please provide
clarification.
Feb-03-2021
08:18:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Roche M
olecular s
ystems co
bas sars-c
ov-2Transcription
Error
Feb-03-2021
08:18:40
(UTC-05:00)ACV0PFEINFP6000 Data Ent
ry:
Rosche MTranscription
Error
090177e196ae3ec5\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-2021-5683-0810327
Page 166 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time
(US &
Canada)olecular s
ystems co
bas sars-c
ov-2
Dec-22-2020
02:47:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse
satisfies query
Dec-21-2020
08:06:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredChanged
Information
Dec-21-2020
08:06:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NALT un
knownChanged
Information
Dec-21-2020
02:57:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedAs per CRF CR,
If trade name is
not known.
Please update
NALT
Unknown in the
specified field,
Thank you.
Dec-20-2020
13:17:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
UNK AL
TInitial Entry
090177e196ae3ec5\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-2021-5683-0810328
Page 167 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-20-2020 13:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-20-2020 13:18:04
(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
Dec-20-2020 13:18:04
(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
Dec-20-2020 13:19:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-20-2020 13:19:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was hospitalized then qua
rantined in hotel. Refused to self s
wab.Changed
Information
Dec-20-2020 13:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text or
between words.
Please correct by
removing all data in
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810329
Page 168 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
the field and
re-enter without
adding extra spaces
or using enter or tab
keys.
Dec-20-2020 13:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was hospitalized then qua
rantined in hotel. Refused to self s
wab.Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810330
Page 169 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-20-2020 13:18:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-20-2020 13:18:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-20-2020 13:18:13
(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
Dec-20-2020 13:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-20-2020 13:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was hospitalized then qua
rantined in hotel. Refused to self s
wab.Changed
Information
Dec-20-2020 13:18:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text or
between words.
Please correct by
removing all data in
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810331
Page 170 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
the field and
re-enter without
adding extra spaces
or using enter or tab
keys.
Dec-20-2020 13:18:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject was hospitalized then qua
rantined in hotel. Refused to self s
wab.Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810332
Page 171 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae3ec5\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-2021-5683-0810333
Page 172 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-20-2020 13:18:36
(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
Dec-20-2020 13:18:36
(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
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-20-2020 13:18:36
(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
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
090177e196ae3ec5\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-2021-5683-0810334
Page 173 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-20-2020 13:18:36
(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
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:TELEPHONE C
ONSULTATION
Occurrence of
Visits or Conta
cts:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae3ec5\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-2021-5683-0810335
Page 174 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-20-2020 13:18:36
(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
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.f
Date Location User Value Reason
Mar-08-2021 20:11:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOTranscription Error
Feb-01-2021 14:19:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:OTHER
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
Feb-01-2021 14:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:Changed
Information
Dec-20-2020 13:18:36
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHInitial Entry
090177e196ae3ec5\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-2021-5683-0810336
Page 175 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) ER
Occurrence of Visits or
Contacts:NO
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810337
Page 176 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User ValueReason
Mar-12-2021
13:04:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
seddata updated
Mar-12-2021
10:25:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredChanged data per
query
Mar-09-2021
17:24:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
3: Ope
nedDMW7648170;"Other
Type of Practitioner
Specify" is not null,
but Occurrence of
Visits or Contacts for
"Other" is NO. Please
review and update as
appropriate.
Mar-09-2021
12:03:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies
query
Mar-08-2021
20:11:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredTranscription Error
090177e196ae3ec5\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)
FDA-CBER-2021-5683-0810338
Page 177 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
20:11:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOTranscription Error
Mar-04-2021
11:25:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ope
nedClin: Other is
answered as YES but
Other Specify is N/A,
please confirm.
Feb-01-2021
21:27:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_HOHCU002_03
Feb-01-2021
14:19:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
YES
Num
ber o
f Visi
ts or
Cont
acts:
1Initial Entry
Feb-01-2021
14:18:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredChanged Information
Feb-01-2021
14:18:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Changed Information
090177e196ae3ec5\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)
FDA-CBER-2021-5683-0810339
Page 178 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-01-2021
01:01:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM : Occurrence of
Visits or Contacts for
"Other" is NO.
However, Other Type
of Practitioner
Specify" is also
recorded. Please
review and update.
Else,clarify.
Jan-29-2021
10:06:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredThe Answer to
OTHER is NO which
is entered.
Jan-28-2021
15:39:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW7047523;"Other
Type of Practitioner
Specify" is not null,
but Occurrence of
Visits or Contacts for
"Other" is NO. Please
review and update as
appropriate.
Dec-20-2020
13:18:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOInitial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Mar-12-2021 10:25:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-01-2021 10:07:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 09:23:37 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ec5\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-2021-5683-0810340
Page 179 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)N/A
Feb-01-2021 08:38:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-01-2021 08:38:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-30-2021 16:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clin: Please remove
as this information
is recorded in HOSP
CRF.
Jan-29-2021 09:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The patient was seen in the ER th
en admitted to from 03 Dec 2020
to 07 Dec 2021Transcription Error
Jan-28-2021 08:25:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The patient was seen in the ER th
en admitted to from 03 Dec 2020
to 07 Dec 202sInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-01-2021 16:22:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 14:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered completed as
applicable.
Jan-27-2021 13:33:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clin: Please
complete LAB
HEM, VITALS
COV, PULSE OX,
OXYGEN,
VASOPRESS, and
IMAGING CRFs, as
applicable.
090177e196ae3ec5\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),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810341
Page 180 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-27-2021 08:45:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered The patient Medical
Records were
received and
attached.
Dec-21-2020 09:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Query: As
this subject was
hospitalized, please
enter on the CRF
form any available
information
(hospitalization, vital
signs, pulse oxymet,
respiratory treatment,
lab results,
imaging…). Please
make every effort to
obtain these
information.
Dec-20-2020 13:18:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Has the subject been in intensiv
e care due to potential COVID-
19 illness?
NOInitial Entry
090177e196ae3ec5\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-2021-5683-0810342
Page 181 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-21-2021 09:56:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810343
Page 182 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Jan-21-2021 09:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Jan-24-2021 08:40:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-21-2021 09:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Jan-21-2021 09:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
Jan-21-2021 09:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: The subject
has been
hospitalized. Please
complete this CRF
form.
3. Admission Date:
Date Location User Value Reason
Jan-27-2021 09:20:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Transcription Error
Jan-21-2021 09:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
090177e196ae3ec5\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-2021-5683-0810344
Page 183 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-27-2021 09:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Dec/7/2020Transcription Error
Jan-21-2021 09:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Dec/8/2020Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810345
Page 184 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-29-2021 09:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810346
Page 185 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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
Jan-29-2021 09:47:15
(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
Jan-29-2021 09:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
YESInitial Entry
3. Treatment:
Date Location User Value Reason
Jan-29-2021 09:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NON-INVASIVE POSITIVE PRE
SSURE VENTILATIONInitial Entry
4. Treatment:
Date Location User Value Reason
Jan-29-2021 09:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NON-INVASIVE POSITIVE PRE
SSURE VENTILATIONInitial Entry
5. Start Date:
Date Location User Value Reason
Jan-29-2021 09:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
6. Ongoing?
Date Location User Value Reason
Jan-29-2021 09:47:15
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec5\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-2021-5683-0810347
Page 186 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) End Date:
Dec/7/2020
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810348
Page 187 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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
Dec-20-2020 13:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-01-2021
10:08:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Clo
sedResponse satisfies
query
Feb-01-2021
08:51:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Ans
weredClarification
Feb-01-2021
08:51:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory
Illness Diag
nosis:
COVID-1
9 pneumo
nia
Date of Dia
gnosis:
Dec/3/202
0Clarification
Jan-30-2021
16:30:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ope
nedClin: Per ILL
SEVERE CRF,
please consider
updating diagnosis
to "COVID-19
090177e196ae3ec5\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-2021-5683-0810349
Page 188 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
pneumonia."
Dec-22-2020
14:05:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Clo
sedResponse satisfies
query
Dec-22-2020
07:54:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Ans
weredTranscription
Error
Dec-22-2020
07:54:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory
Illness Diag
nosis:
COVID-1
9
Date of Dia
gnosis:
Dec/3/202
0Transcription
Error
Dec-21-2020
09:06:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ope
nedClin: As subject is
symptomatic and
has a positive
local test,
'COVID-19'
should be
recorded.
Dec-21-2020
08:48:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: Clo
sedDiscrepancy has
been closed.
Dec-21-2020
08:06:59
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 2: Ans
weredChanged
Information
090177e196ae3ec5\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)
FDA-CBER-2021-5683-0810350
Page 189 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
Dec-21-2020
08:06:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory
Illness Diag
nosis:
CORONA
VIRUS IN
FECTION
DISEASE
Date of Dia
gnosis:
Dec/3/202
0Changed
Information
Dec-20-2020
14:01:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 2: Ope
nedClarify COVID as
follows...The term
is unclear and
appears truncated.
Are you reporting
CORONAVIRUS
INFECTION
DISEASE?
COVID-19?
COVID-19
VIRUS TEST?
COVID-19
SUSPECTED? If
so, update the
verbatim term as
such. Otherwise
clarify and edit the
verbatim
accordingly.
Thank you.
Dec-20-2020
13:19:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Clo
sedClose Auto Query
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810351
Page 190 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-20-2020
13:19:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory
Illness Diag
nosis:
covid
Date of Dia
gnosis:
Dec/3/202
0Changed
Information
Dec-20-2020
13:18:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ope
nedYes is selected,
however, either
the diagnosis
details or date of
diagnosis is
missing. Please
correct.
Dec-20-2020
13:18:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Dia
gnosis:
Dec/3/202
0Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-20-2020 13:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae3ec5\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-2021-5683-0810352
Page 191 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-27-2021 09:31:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810353
Page 192 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 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 15:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-02-2021 15:41:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-27-2021 09:31:26
(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
Jan-27-2021 09:38:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Was a diagnosis obtained?
Date Location User Value Reason
Feb-03-2021
09:50:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
ClosedResponse
satisfies query
Feb-02-2021
15:41:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Not Appli
cableInitial Entry
Feb-02-2021
15:41:38
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 auto query (autoquery) Query 5:
ClosedClose Auto
Query
090177e196ae3ec5\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-2021-5683-0810354
Page 193 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US &
Canada)
Feb-02-2021
15:41:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:Transcription
Error
Feb-02-2021
15:40:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query 5:
OpenedResponse to
"Was a
diagnosis
obtained?" is
No. Please
review and
update as
appropriate.
Feb-02-2021
15:40:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query 3:
AnsweredChanged
Information
Feb-02-2021
15:40:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NOChanged
Information
Feb-01-2021
16:24:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
Reissued:
OpenedClin:
Diagnosis of
COVID-19
pneumonia
already
recorded on
ILL POTEN
CRF. If no
diagnosis of
renal, hepatic,
or
neurological
dysfunction,
please clear
090177e196ae3ec5\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-2021-5683-0810355
Page 194 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
data and mark
with FORM
LEVEL
comment of
Not
Applicable.
Feb-01-2021
14:50:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 4:
ClosedDiscrepancy
has been
closed.
Feb-01-2021
12:26:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query 4:
AnsweredClarification
Feb-01-2021
12:26:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query 3:
AnsweredClarification
Feb-01-2021
12:26:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
YES
Diagnos
is:
COVI
D19 Vi
ral Pne
umoni
a
Start Da
te:
Dec/3/
2020
OngoingClarification
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810356
Page 195 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
?:
NO
End
Date:
Dec
/7/2
020
Feb-01-2021
12:10:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 4:
OpenedSpecial
Characters:
Verbatim Term
contains
embedded
non-compliant
characters.
Feb-01-2021
10:43:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 2:
ClosedDiscrepancy
has been
closed.
Feb-01-2021
10:10:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
Reissued:
OpenedClin: Please
complete with
diagnosis
related to
significant
renal, hepatic,
or
neurological
dysfunction
only. Viral
pneumonia
already
recorded on
ILL POTEN
CRF.
Feb-01-2021
09:22:14
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 auto query (autoquery) Query 3:
AnsweredClarification
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810357
Page 196 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Canada)
Feb-01-2021
09:22:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query 2:
AnsweredClarification
Feb-01-2021
09:22:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
YES
Diagnos
is:
Acute
hypoxi
c Resp
iratory
failure
COVI
D19 Vi
ral Pne
umoni
a
Start Da
te:
Dec/3/
2020
Ongoing
?:
NO
End
Date:
Dec
/7/2
020Clarification
Feb-01-2021
09:01:10
(UTC-05:00)ACV0PFEINFP6000 Query 2:
Reissued:
OpenedPlease only
record the
most relevant
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810358
Page 197 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time
(US &
Canada)or most severe
diagnosis.
Jan-30-2021
16:36:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
OpenedClinical
Query: Per
CRF CRs
Section 8.34,
this CRF
should only be
completed if a
participant had
significant
renal, hepatic
or
neurological
dysfunction as
part of their
potential
COVID-19
illness.
Jan-28-2021
12:55:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
AnsweredCan you
please explain:
Verbatim Term
contains
embedded
non-compliant
characters.
Jan-28-2021
10:24:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 2:
OpenedSpecial
Characters:
Verbatim Term
contains
embedded
non-compliant
characters.
Jan-28-2021
09:10:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
ClosedDiscrepancy
has been
closed.
Jan-28-2021
08:10:23ACV0PFEINFP6000 auto query (autoquery) Query 1:
AnsweredTranscription
Error
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810359
Page 198 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time
(US &
Canada)
Jan-28-2021
08:10:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
YES
Diagnos
is:
Acute
hypoxi
c Resp
iratory
failure
COVI
D19 Vi
ral Pne
umoni
a
Hypot
ension
Bicyto
penia
Start Da
te:
Dec/3/
2020
Ongoing
?:
NO
End
Date:
Dec
/7/2
020Transcription
Error
Jan-27-2021
11:51:04ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1:
OpenedSpecial
Characters:
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810360
Page 199 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time
(US &
Canada)Verbatim Term
contains
embedded
non-compliant
characters.
Jan-27-2021
09:31:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
YES
Diagnos
is:
Acute
hypoxi
c Resp
iratory
failure
COVI
D-19
Viral P
neumo
nia
Hypot
ension
Bicyto
penia
Start Da
te:
Dec/3/
2020
Ongoing
?:
NO
End
Date:
Dec
/7/2
020Initial Entry
4. Toxicity Grade:
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810361
Page 200 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: 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: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-02-2021 15:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-02-2021 15:41:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-27-2021 09:31:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae3ec5\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-2021-5683-0810362
Page 201 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 21-Aug-2020 02:49 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810363
Page 202 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-27-2021 10:21:44
(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
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Name:
AHS
MORRISTOWN MEDICAL CEN
TER LAB
Address:
100 Madison Avenue,
Morristown, NJ 07960Initial Entry
3. Collection Date:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/3/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Prot
ein_PX329Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810364
Page 203 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: 24.7
Not Done::
Lab Normal Ra
nge:Low
0.0
High
9.0
Unit
mg/L
5.a Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24.7Initial Entry
5.a LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.0
High
9.0Initial Entry
090177e196ae3ec5\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-2021-5683-0810365
Page 204 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unit
mg/L
5.b
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:30
Test:: Alanine Aminotra
nsferase_PX30
Result:: 31
Not Done::
Lab Normal R
ange:Low
12
High
59
Unit
U/LInitial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810366
Page 205 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
31Initial Entry
5.b LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
12
High
59
Unit
U/LInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:28
Test:: Aspartate Aminotr
ansferase_PX28Initial Entry
090177e196ae3ec5\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-2021-5683-0810367
Page 206 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: 29
Not Done::
Lab Normal R
ange:Low
15
High
37
Unit
U/L
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810368
Page 207 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aspartate Aminotransferase_PX28Initial Entry
5.c Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
29Initial Entry
5.c LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
15
High
37
Unit
U/LInitial Entry
5.d
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:35
Test:: Alkaline Phosph
atase_PX35Initial Entry
090177e196ae3ec5\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-2021-5683-0810369
Page 208 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: 66
Not Done::
Lab Normal Ra
nge:Low
45
High
117
Unit
U/L
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810370
Page 209 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
66Initial Entry
5.d LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
45
High
117
Unit
U/LInitial Entry
5.e
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ide
ntifier:21
Test:: Bilirubin_P
X21Initial Entry
090177e196ae3ec5\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-2021-5683-0810371
Page 210 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: 0.9
Not Done::
Lab Normal Range: Low
0.0
High
1.1
Unit
mg/dL
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810372
Page 211 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.e Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
0.9Initial Entry
5.e LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.0
High
1.1
Unit
mg/dLInitial Entry
5.f
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:47
Test:: Blood Urea Nitr
ogen_PX47Initial Entry
090177e196ae3ec5\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-2021-5683-0810373
Page 212 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: 22
Not Done::
Lab Normal Ra
nge:Low
7
High
18
Unit
mg/dL
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810374
Page 213 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.f Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
5.f LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
7
High
18
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:48
Test:: Creatinine_P
X48Initial Entry
090177e196ae3ec5\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-2021-5683-0810375
Page 214 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Result:: 0.95
Not Done::
Lab Normal Range
:Low
0.60
High
1.30
Unit
mg/dL
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810376
Page 215 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.g Sponsor ID:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
0.95Initial Entry
5.g LNMT
Date Location User Value Reason
Jan-27-2021 10:21:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.60
High
1.30
Unit
mg/dLInitial Entry
090177e196ae3ec5\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-2021-5683-0810377
Page 216 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-29-2021 08:27:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810378
Page 217 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461235 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-29-2021 08:27:21
(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
Jan-29-2021 08:27:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AHS
Morristown Medical center labsInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-29-2021 08:27:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/13/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Jan-29-2021 08:27:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Jan-29-2021 08:27:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:1
Test:: Hemoglobin
_PX1
Result:: 14.6
Not Done::Initial Entry
090177e196ae3ec5\Final\Final On: 01-Apr-2021 05:00 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CB
…[truncated]