Document text
Page 1 of 277
***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: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809734
Page 2 of 277
***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: 11461191 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/2/2020
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809735
Page 3 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11461191]
2.Birth Date: /1943
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809736
Page 4 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809737
Page 5 of 277
***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: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809738
Page 6 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809739
Page 7 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[High Cholesterol]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acid Reflux]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809740
Page 8 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Controlled Sleep Apnea]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1970
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[COPD]
Start Date: UNK/UNK/2014
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cardiac Arrhythmia]
Start Date: Feb/UNK/2020
Ongoing: YES
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809741
Page 9 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Post Menopausal]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809742
Page 10 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [265.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [50.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809743
Page 11 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809744
Page 12 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249513]
3.Randomization Group: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809745
Page 13 of 277
***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: 11461191 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/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 [BP19FS]
5.bSample ID [BPHD0X]
5.cSample ID [BPHD0V]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809746
Page 14 of 277
***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: 11461191 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/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 [BP19FP]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809747
Page 15 of 277
***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: 11461191 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/2/2020 13:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809748
Page 16 of 277
***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: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809749
Page 17 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809750
Page 18 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809751
Page 19 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809752
Page 20 of 277
***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: 11461191 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/23/2020
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 [BP9CCD]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809753
Page 21 of 277
***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: 11461191 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/23/2020 12:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809754
Page 22 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809755
Page 23 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTX18]
5.bSample ID [BPW265]
5.cSample ID [BRTX19]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809756
Page 24 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809757
Page 25 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/11/2021
2.Date of First Symptom
Started:Jan/7/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/13/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809758
Page 26 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [fatigue]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809759
Page 27 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809760
Page 28 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809761
Page 29 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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? YES
Date of Collection:
Jan/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 [CV13294]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809762
Page 30 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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:[Self swab performed.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809763
Page 31 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809764
Page 32 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809765
Page 33 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809766
Page 34 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809767
Page 35 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 2
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809768
Page 36 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809769
Page 37 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809770
Page 38 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809771
Page 39 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809772
Page 40 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809773
Page 41 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809774
Page 42 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809775
Page 43 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809776
Page 44 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809777
Page 45 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809778
Page 46 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809779
Page 47 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809780
Page 48 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809781
Page 49 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809782
Page 50 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809783
Page 51 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809784
Page 52 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809785
Page 53 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
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 [BSDZX2]
5.bSample ID [BSDZX1]
5.cSample ID [BRR4TF]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809786
Page 54 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809787
Page 55 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809788
Page 56 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809789
Page 57 of 277
***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: 11461191 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: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809790
Page 58 of 277
***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: 11461191 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:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809791
Page 59 of 277
***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: 11461191 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 [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809792
Page 60 of 277
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Pneumon
ia Feb/17/2021 U
NK:UNK NO
End Date Time:
Feb/21/2021 UNK:
UNK
Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809793
Page 61 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pneumonia]
4.Start Date Time: Feb/17/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/21/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809794
Page 62 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pneumonia Hospitilization]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809795
Page 63 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021236973]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809796
Page 64 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809797
Page 65 of 277
***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: 11461191 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[ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809798
Page 66 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809799
Page 67 of 277
***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: 11461191 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: //
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809800
Page 68 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809801
Page 69 of 277
***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: 11461191 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?
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809802
Page 70 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809803
Page 71 of 277
***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: 11461191 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?
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809804
Page 72 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809805
Page 73 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809806
Page 74 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809807
Page 75 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809808
Page 76 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809809
Page 77 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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?
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809810
Page 78 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809811
Page 79 of 277
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809812
Page 80 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809813
Page 81 of 277
***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: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809814
Page 82 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809815
Page 83 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809816
Page 84 of 277
***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: 11461191 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: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809817
Page 85 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809818
Page 86 of 277
***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: 11461191 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/25/2021
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809819
Page 87 of 277
***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: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809820
Page 88 of 277
***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: 11461191 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/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809821
Page 89 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809822
Page 90 of 277
***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: 11461191 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[HARD STICK]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809823
Page 91 of 277
***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: 11461191 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/25/2021
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 [BRR4KH]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809824
Page 92 of 277
***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: 11461191 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/25/2021 11:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809825
Page 93 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809826
Page 94 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809827
Page 95 of 277
***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: 11461191 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/15/2021
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 [BRR4TD]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809828
Page 96 of 277
***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: 11461191 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/15/2021 13:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809829
Page 97 of 277
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809830
Page 98 of 277
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809831
Page 99 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809832
Page 100 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809833
Page 101 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809834
Page 102 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809835
Page 103 of 277
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809836
Page 104 of 277
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809837
Page 105 of 277
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809838
Page 106 of 277
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809839
Page 107 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-02-2020 14:13:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809840
Page 108 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Sep-02-2020 14:19:59 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809841
Page 109 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Sep-23-2020 13:59:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809842
Page 110 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809843
Page 111 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809844
Page 112 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809845
Page 113 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809846
Page 114 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809847
Page 115 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809848
Page 116 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809849
Page 117 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
7Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809850
Page 118 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
8Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809851
Page 119 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
9Jan-12-2021 10:46:02 (UTC-05:00)
Eastern Time (US & Canada)self swab performed.
Not Done
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809852
Page 120 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-25-2021 12:27:57 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809853
Page 121 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809854
Page 122 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Jan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809855
Page 123 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Jan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809856
Page 124 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Jan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809857
Page 125 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Jan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809858
Page 126 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Jan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809859
Page 127 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aJan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809860
Page 128 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aJan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809861
Page 129 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aJan-25-2021 12:28:26 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809862
Page 130 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809863
Page 131 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809864
Page 132 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809865
Page 133 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809866
Page 134 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809867
Page 135 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809868
Page 136 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809869
Page 137 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809870
Page 138 of 277
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aFeb-15-2021 18:54:04 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809871
Page 139 of 277
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-15-2021 14:24:11 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-26-2021 12:53:16 (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-25-2021 12:26:52 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809872
Page 140 of 277
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
N/A
Robert
Falcone Approved Jan-21-2021 08:30:51 (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.
N/A Jan-12-2021 10:44:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Falcone Approved Oct-27-2020 11:06:21 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809873
Page 141 of 277
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
By my dated signature below, I, RobertFalcone, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809874
Page 142 of 277
***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: 11461191 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-02-2020
14:12:47
(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-02-2020
14:12:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809875
Page 143 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
14:12:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/2/2020Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809876
Page 144 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
14:12:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11461191Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
14:12:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1943Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
14:13:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809877
Page 145 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-02-2020
14:13:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
14:13:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809878
Page 146 of 277
***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: 11461191 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-02-2020
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809879
Page 147 of 277
***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: 11461191 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-02-2020
14:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
14:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
14:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809880
Page 148 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
14:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/199
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:14:06
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809881
Page 149 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-02-2020
14:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020
14:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-02-2020
14:14:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:High Ch
olesterol
Start Date: UNK/U
NK/201
5
Ongoing: YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809882
Page 150 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:14:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:14:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
High CholesterolInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020
14:14:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020
14:14:29ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809883
Page 151 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-02-2020
14:14:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Acid Ref
lux
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809884
Page 152 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:14:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:14:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Acid RefluxInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020
14:14:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020
14:14:58ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809885
Page 153 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.d
Date Location User Value Reason
Sep-02-2020
14:15:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:Controlled
Sleep Apn
ea
Start Date
:UNK/UN
K/2015
Ongoing: YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809886
Page 154 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:15:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:15:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Controlled Sleep Ap
neaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020
14:15:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-02-2020
14:15:22ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809887
Page 155 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.e
Date Location User Value Reason
Sep-02-2020
14:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:Seasonal
Allergies
Start Date: UNK/U
NK/1970
Ongoing: YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809888
Page 156 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-02-2020
14:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-02-2020
14:15:47ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809889
Page 157 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-02-2020
14:17:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:COPD
Start Date: UNK/U
NK/201
4
Ongoing: YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809890
Page 158 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:17:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:17:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COPDInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-02-2020
14:17:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-02-2020
14:17:25ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809891
Page 159 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.g
Date Location User Value Reason
Sep-02-2020
14:18:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical Hi
story Term
:Cardiac
Arrhythm
ia
Start Date: Feb/UNK
/2020
Ongoing: YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809892
Page 160 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:18:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:18:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Cardiac ArrhythmiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-02-2020
14:18:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2020Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-02-2020
14:18:33ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809893
Page 161 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.h
Date Location User Value Reason
Sep-02-2020
14:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:Post Meno
pausal
Start Date
:UNK/UN
K/1995
Ongoing: NO
End Date
:
UNK/U
NK/199
5Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809894
Page 162 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.h Line/MH Number:
Date Location User Value Reason
Sep-02-2020
14:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
14:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Post MenopausalInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-02-2020
14:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-02-2020
14:19:04ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809895
Page 163 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1995
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809896
Page 164 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
265.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809897
Page 165 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
50.1Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.8Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809898
Page 166 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809899
Page 167 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
14:19:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809900
Page 168 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
3. Collection Date:
Date Location User Value Reason
Sep-02-2020
14:19:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020
14:20:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor
-Defined
Identifie
r:113
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::NOT DO
NEInitial Entry
Sep-02-2020
14:19:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor
-Defined
Identifie
r:Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809901
Page 169 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020
14:20:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020
14:19:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020
14:20:10
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809902
Page 170 of 277
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809903
Page 171 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
14:20:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
14:20:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
249513Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809904
Page 172 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020
14:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020
14:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020
20:32:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020
14:20:51
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809905
Page 173 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-02-2020
14:20:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020
20:32:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP19F
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020
20:32:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP19FSInitial Entry
5.b
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809906
Page 174 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-02-2020
20:32:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPHD0
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020
20:32:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPHD0XInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020
20:33:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPHD0
VInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809907
Page 175 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Sep-02-2020
20:33:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPHD0VInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809908
Page 176 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020
14:20:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020
14:20:58
(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-02-2020
20:33:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020
14:20:58
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809909
Page 177 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-02-2020
14:20:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020
20:33:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP19F
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020
20:33:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP19FPInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809910
Page 178 of 277
***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: 11461191 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-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809911
Page 179 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 13:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809912
Page 180 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-02-2020
14:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809913
Page 181 of 277
***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: 11461191 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-02-2020
14:21:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809914
Page 182 of 277
***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: 11461191 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-23-2020
13:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809915
Page 183 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020
13:58:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020
13:58:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.2
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020
13:58:49
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809916
Page 184 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-23-2020
13:58:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020
13:58:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020
13:58:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809917
Page 185 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
3. Collection Date:
Date Location User Value Reason
Sep-23-2020
13:59:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-23-2020
13:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor
-Defined
Identifie
r:113
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::NOT DO
NEInitial Entry
Sep-23-2020
13:59:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor
-Defined
Identifie
r:Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809918
Page 186 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Test:: Choriogo
nadotropi
n Beta_P
X113
Result::
Not Don
e::
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020
13:59:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020
13:59:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-23-2020
13:59:20
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809919
Page 187 of 277
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809920
Page 188 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020
13:59:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020
13:59:29
(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-24-2020
08:57:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-24-2020
05:35:15
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809921
Page 189 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-23-2020
13:59:29
(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-23-2020
13:59:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
08:57:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9CC
DInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809922
Page 190 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-24-2020
08:57:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9CCDInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809923
Page 191 of 277
***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: 11461191 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-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809924
Page 192 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 12:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020
14:00:02
(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-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809925
Page 193 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-23-2020
14:00:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809926
Page 194 of 277
***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: 11461191 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-22-2020
11:57:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809927
Page 195 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
14:45:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
14:45:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
14:45:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809928
Page 196 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-21-2020
14:45:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTX1
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
14:45:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTX18Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020
14:45:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPW26
5Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
14:45:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPW265Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809929
Page 197 of 277
***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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c
Date Location User Value Reason
Oct-21-2020
14:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRTX1
9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
14:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTX19Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809930
Page 198 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021
04:49:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Feb-18-2021
11:57:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answere
dconvalescent
visit for illness
that occurred
on 11-Jan-2021
was conducted
15-Feb-2021.
Feb-16-2021
01:14:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened PDQ:
Convalescent
visit is missing
and 35 days
(36) have
passed since
COVID Illness
Visit. If visit
occurred
record data as a
matching
CONVA visit;
if visit did not
occur attempt
to schedule
visit even if
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809931
Page 199 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
OOW and
obtain the
CONVA
sample else
clarify.
Jan-12-2021
10:46:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jan-12-2021
10:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
eDate of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing. Please
review and
update as
appropriate.
Jan-12-2021
10:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eDate of Visit is
completed but
Date of
Collection in
both Nasal
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809932
Page 200 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Jan-12-2021
10:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-12-2021
10:44:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809933
Page 201 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/11/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-05-2021
15:27:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-05-2021
13:45:28
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809934
Page 202 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
Mar-05-2021
13:45:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Sym
ptom Resolved:
Jan/13/2021New
Information
Mar-01-2021
16:47:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clin: As
subject was
recently
vaccinated on
25Jan2021,
please clarify
whether the
reported
symptoms are
still ongoing.
If symptoms
have ended,
please update
‘Symptoms
Ongoing’ to
‘NO’ and add
Date of Last
Symptom
Resolved on
the CRF.
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809935
Page 203 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
4.a
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pre
sent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809936
Page 204 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED SInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809937
Page 205 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)HORTNESS
OF BREATH
Symp
tom P
resen
t:NO
4.c Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LSInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809938
Page 206 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) Symptom Pr
esent:NO
4.d Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE PA
IN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809939
Page 207 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.e Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809940
Page 208 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.f Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809941
Page 209 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.g Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:YESInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809942
Page 210 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.h Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809943
Page 211 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i Symptoms:
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-12-2021
10:45:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jan-12-2021
10:45:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - O
ther:fatig
ueInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-12-2021
10:45:35ACV0PFEINFP6000 Data Entry:
fatigueInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809944
Page 212 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809945
Page 213 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809946
Page 214 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809947
Page 215 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8. Comments/Findings/Details:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-12-2021
10:46:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809948
Page 216 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021
10:46:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021
10:46:28
(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
Jan-12-2021
10:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-12-2021
10:46:28
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809949
Page 217 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-12-2021
10:46:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021
10:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:CV1329
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-12-2021
10:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CV13294Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809950
Page 218 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021
10:47:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021
10:47:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021
10:47:31
(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:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809951
Page 219 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-12-2021
10:47:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Self swab performed.Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809952
Page 220 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALI
ST
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809953
Page 221 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMERG
ENCY
ROOM
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809954
Page 222 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809955
Page 223 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021
10:47:47
(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
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Type of
PractitioTELEPHO
NE CONSInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809956
Page 224 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)ner: ULTATIO
N
Occurre
nce of Vi
sits or C
ontacts:YES
Number
of Visits
or Conta
cts:
1
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021
10:47:47
(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
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809957
Page 225 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-12-2021
10:47:47
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809958
Page 226 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: 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: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809959
Page 227 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/11/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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
Jan-12-2021
10:49:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-12-2021
10:49:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-12-2021
10:49:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0809960
Page 228 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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-15-2021
14:24:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/15/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-19-2021
03:01:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Close
dResponse satisfies
query
Feb-18-2021
11:50:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredTranscription Error
Feb-18-2021
11:50:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Transcription Error
Feb-16-2021 ACV0PFEINFP6000 Query 1: Open DM: Convalescent
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809961
Page 229 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
01:25:32
(UTC-05:00)
Eastern Time
(US & Canada)ed visit - COVID_B1
has been updated,
however
corresponding
COVID illness
visit - COVID_B is
not present. Please
review and update
this
CONVALESCENT
visit as
appropriate, else
clarify further.
Thank you.
Feb-15-2021
18:53:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_B1Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809962
Page 230 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-15-2021
18:53:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021
18:53:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-15-2021
18:53:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809963
Page 231 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-15-2021
14:30:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSDZX
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-15-2021
14:30:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSDZX2Initial Entry
5.b
Date Location User Value Reason
Feb-15-2021
14:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSDZX
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-15-2021
14:30:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSDZX1Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809964
Page 232 of 277
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/15/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c
Date Location User Value Reason
Feb-15-2021
14:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRR4T
FInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-15-2021
14:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRR4TFInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0809965
Page 233 of 277
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020
11:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020
11:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020
11:57:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0809966
Page 234 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809967
Page 235 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PneumoniaInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809968
Page 236 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/21/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809969
Page 237 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-09-2021
02:12:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Pneumonia:
Response to
"Is the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolonInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809970
Page 238 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
g hospitalization?
YES
Did this serious eve
nt result in persiste
nt or significant dis
ability/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically im
portant serious eve
nt
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809971
Page 239 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-08-2021
13:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify
:
Pneumonia Ho
spitilizationTranscription
Error
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809972
Page 240 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
13:03:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809973
Page 241 of 277
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-09-2021
02:12:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021236973Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0809974
Page 242 of 277
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021
12:26:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809975
Page 243 of 277
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-25-2021
12:27:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-25-2021
12:27:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-25-2021
12:27:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loc
al/national reco
mmendations a
nd confirmed tInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809976
Page 244 of 277
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
o have receive
d only placebo
at Vaccination
1/2
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0809977
Page 245 of 277
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-25-2021
12:27:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-25-2021
12:27:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809978
Page 246 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021
12:27:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809979
Page 247 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-25-2021
12:27:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Jan/25/2021Initial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809980
Page 248 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 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
Jan-25-2021
12:28:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-25-2021
12:28:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-25-2021
12:28:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809981
Page 249 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809982
Page 250 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-D
efined Iden
tifier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3ec9\Final\Final On: 01-Apr-2021 05:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0809983
Page 251 of 277
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1146 Site Name: (1146) Amici Clinical Research
Subject No: 11461191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
6.a Sponsor ID:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-25-2021
12:28:26
(UTC-05:00)
…[truncated]