125742 S1 M5 CRF c4591001 1147 11471230

Document text

Page 1 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811027
Page 2 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/9/2020
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811028
Page 3 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11471230]
2.Birth Date: /1961
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:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811029
Page 4 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811030
Page 5 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811031
Page 6 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811032
Page 7 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:[intractable migraine without aura]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mild coronary artery disease]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811033
Page 8 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic rhinitis]
Start Date: UNK/UNK/2011
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[factor V leiden disorder]
Start Date: UNK/UNK/2014
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2019
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Degenerative disc disease,lumbar]
Start Date: UNK/UNK/2000
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cervical radiculopathy]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811034
Page 9 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right foot pain]
Start Date: UNK/UNK/2017
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic to hydrocodone]
Start Date: UNK/UNK/2000
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic to oxycodone]
Start Date: UNK/UNK/2000
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic doxycycline]
Start Date: UNK/UNK/2018
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[menopausal]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811035
Page 10 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [226.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [38.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811036
Page 11 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811037
Page 12 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [253202]
3.Randomization Group: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811038
Page 13 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPLF4V]
5.bSample ID [BPY3DS]
5.cSample ID [BPY3DT]
5.dSample ID [BPY3DV]
5.eSample ID [BPLF4D]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811039
Page 14 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3D6]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811040
Page 15 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/9/2020 13:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811041
Page 16 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811042
Page 17 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811043
Page 18 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811044
Page 19 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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: Not Applicable
[ ]Comments
Test: Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811045
Page 20 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/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 [BR7XC3]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811046
Page 21 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/2/2020 09:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811047
Page 22 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811048
Page 23 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/30/2020
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 [BMNV16]
5.bSample ID [BMNV1G]
5.cSample ID [BR7XM1]
5.dSample ID [BR7XM0]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811049
Page 24 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811050
Page 25 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/1/2021
2.Date of First Symptom Started: Jan/29/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811051
Page 26 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.Symptoms - Other Text: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811052
Page 27 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/30/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0811053
Page 28 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/30/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811054
Page 29 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:
Feb/22/2021
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 [RW89794]
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(b) (4)
FDA-CBER-2021-5683-0811055
Page 30 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:[Site did not collect swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0811056
Page 31 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811057
Page 32 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Feb/2/2021  NO
Discharge Date:
Feb/6/2021
 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0811058
Page 33 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Feb/2/2021
4.Ongoing? NO
Discharge Date:
Feb/6/2021
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(b) (4)
FDA-CBER-2021-5683-0811059
Page 34 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatment TreatmentStart D
ateForm Instan
ce
 1.1  YES  HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Feb/2/2
021 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0811060
Page 35 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Feb/2/2021
6.Ongoing? NO
End Date:
Feb/6/2021
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811061
Page 36 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Jan/30/2021
3.Toxicity Grade: 2
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811062
Page 37 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0811063
Page 38 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811064
Page 39 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.CLINICAL C
HEMISTRY St. Tammany P
arish Hospital
1202 S Tyler St.
Covington, LA
70433 Feb/2/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 5.50
 
30  Alanine Aminotra
nsferase_PX30 30 
28  Aspartate Aminotr
ansferase_PX28 44 
35  Alkaline Phosphat
ase_PX35 80 
21  Bilirubin_PX21  0.6 
47  Blood Urea Nitrog
en_PX47 20 
48  Creatinine_PX48  1.11
 Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811065
Page 40 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 2.CLINICAL C
HEMISTRY St. Tammany P
arish Hospital
1202 S Tyler St.
Covington, LA
70433 Feb/3/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 [ ] 
30  Alanine Aminotra
nsferase_PX30 37 
28  Aspartate Aminotr
ansferase_PX28 48 
35  Alkaline Phosphat
ase_PX35 76 
21  Bilirubin_PX21  0.6 
47  Blood Urea Nitrog
en_PX47 25 
48  Creatinine_PX48  1.03
 Repeating
Pages
 3.CLINICAL C
HEMISTRY St. Tammany P
arish Hospital
1202 S Tyler St.
Covington, LA
70433 Feb/4/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 2.40
 
30  Alanine Aminotra
nsferase_PX30 38 
28  Aspartate Aminotr
ansferase_PX28 47 
35  Alkaline Phosphat
ase_PX35 66 
21  Bilirubin_PX21  0.5 
47  Blood Urea Nitrog
en_PX47 28 
48  Creatinine_PX48  0.86
 Repeating
Pages
 4.CLINICAL C
HEMISTRY St. Tammany P
arish Hospital
1202 S Tyler St
Covington, LAFeb/5/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein [ ] Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811066
Page 41 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
70433 Sponsor-Defin
ed IdentifierTest:Res
ult:
_PX329 
30  Alanine Aminotra
nsferase_PX30 37 
28  Aspartate Aminotr
ansferase_PX28 49 
35  Alkaline Phosphat
ase_PX35 60 
21  Bilirubin_PX21  0.5 
47  Blood Urea Nitrog
en_PX47 29 
48  Creatinine_PX48  0.94
 
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811067
Page 42 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St.
Covington, LA 70433]
3.Collection Date: Feb/2/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [5.50]
Not Done:
LNMT Low
[0.00]
High
[0.90]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [30]
Not Done:
LNMT Low
[0]
High
[35]
Unit
U/L
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811068
Page 43 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [44]
Not Done:
LNMT Low
[14]
High
[36]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [80]
Not Done:
LNMT Low
[38]
High
[145]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811069
Page 44 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [20]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.11]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811070
Page 45 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St.
Covington, LA 70433]
3.Collection Date: Feb/3/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [37]
Not Done:
LNMT Low
[0]
High
[35]
Unit
U/L
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811071
Page 46 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [48]
Not Done:
LNMT Low
[14]
High
[36]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [76]
Not Done:
LNMT Low
[38]
High
[145]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811072
Page 47 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [25]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.03]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811073
Page 48 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St.
Covington, LA 70433]
3.Collection Date: Feb/4/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [2.40]
Not Done:
LNMT Low
[0.00]
High
[0.90]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [38]
Not Done:
LNMT Low
[0]
High
[35]
Unit
U/L
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811074
Page 49 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [47]
Not Done:
LNMT Low
[14]
High
[36]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [66]
Not Done:
LNMT Low
[38]
High
[145]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811075
Page 50 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [28]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.86]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811076
Page 51 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St
Covington, LA 70433]
3.Collection Date: Feb/5/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [37]
Not Done:
LNMT Low
[0]
High
[35]
Unit
U/L
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811077
Page 52 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [49]
Not Done:
LNMT Low
[14]
High
[36]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [60]
Not Done:
LNMT Low
[38]
High
[145]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811078
Page 53 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [29]
Not Done:
LNMT Low
[7]
High
[18]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.94]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811079
Page 54 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.HEMATOLO
GY St. Tammany Pari
sh Hospital
1202 S Tyler St.
Covington, LA 7
0433 Feb/2/202
1 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 13.9 
2  Hematocrit_
PX2 40.6 
3  Erythrocytes
_PX3 4.42 
5  Platelets_PX
5 105 
7  Leukocytes_
PX7 4.87 
608  Neutrophils_
PX608 3.5 
609  Eosinophils_
PX609 0.0 
612  Monocytes_
PX612 0.5 
610  Basophils_P
X610 0.02 
611  Lymphocytes
_PX611 0.9 Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811080
Page 55 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 2.HEMATOLO
GY St. Tammany Pari
sh Hospital
1202 S Tyler St.
Covington, LA 7
0433 Feb/3/202
1 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 13.9 
2  Hematocrit_
PX2 41.0 
3  Erythrocytes
_PX3 4.44 
5  Platelets_PX
5 129 
7  Leukocytes_
PX7 6.28 
608  Neutrophils_
PX608 4.4 
609  Eosinophils_
PX609 0.0 
612  Monocytes_
PX612 0.5 
610  Basophils_P
X610 0.01 
611  Lymphocytes
_PX611 1.3 Repeating
Pages
 3.HEMATOLO
GY St. Tammany Pari
sh Hospital
1202 S Tyler St.
Covington, LA 7
0433 Feb/4/202
1 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 13.2 
2  Hematocrit_
PX2 38.2 
3  Erythrocytes
_PX3 4.15 
5  Platelets_PX
5 135 
7  Leukocytes_
PX7 5.24 Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811081
Page 56 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
Sponsor-Define
d IdentifierTest:Res
ult:
608  Neutrophils_
PX608 3.3 
609  Eosinophils_
PX609 0.0 
612  Monocytes_
PX612 0.6 
610  Basophils_P
X610 0.00 
611  Lymphocytes
_PX611 1.2 
 4.HEMATOLO
GY St. Tammany Pari
sh Hospital
1202 S Tyler St
Covington, LA 7
0121 Feb/5/202
1 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 12.7 
2  Hematocrit_
PX2 37.5 
3  Erythrocytes
_PX3 4.03 
5  Platelets_PX
5 118 
7  Leukocytes_
PX7 5.11 
608  Neutrophils_
PX608 3.2 
609  Eosinophils_
PX609 [ ] 
612  Monocytes_
PX612 [ ] 
610  Basophils_P
X610 [ ] 
611  Lymphocytes
_PX611 [ ] Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811082
Page 57 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St.
Covington, LA 70433]
3.Collection Date: Feb/2/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.9]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.6]
Not Done:
LNMT Low
[37.0]
High
[48.5]
Unit
%
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811083
Page 58 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.42]
Not Done:
LNMT Low
[4.00]
High
[5.40]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [105]
Not Done:
LNMT Low
[150]
High
[350]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [4.87]
Not Done:
LNMT Low
[3.90]
High
[12.70]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811084
Page 59 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.5]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811085
Page 60 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.02]
Not Done:
LNMT Low
[0.0]
High
[2.0]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.9]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811086
Page 61 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St.
Covington, LA 70433]
3.Collection Date: Feb/3/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.9]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [41.0]
Not Done:
LNMT Low
[37.0]
High
[48.5]
Unit
%
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811087
Page 62 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.44]
Not Done:
LNMT Low
[4.00]
High
[5.40]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [129]
Not Done:
LNMT Low
[150]
High
[350]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.28]
Not Done:
LNMT Low
[3.90]
High
[12.70]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811088
Page 63 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.4]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811089
Page 64 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.01]
Not Done:
LNMT Low
[0.0]
High
[0.20]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.3]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811090
Page 65 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St.
Covington, LA 70433]
3.Collection Date: Feb/4/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.2]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38.2]
Not Done:
LNMT Low
[37.0]
High
[48.5]
Unit
g/dL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811091
Page 66 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.15]
Not Done:
LNMT Low
[4.00]
High
[5.40]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [135]
Not Done:
LNMT Low
[150]
High
[350]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.24]
Not Done:
LNMT Low
[3.90]
High
[12.70]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811092
Page 67 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.3]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.6]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811093
Page 68 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.00]
Not Done:
LNMT Low
[0.00]
High
[0.20]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.2]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811094
Page 69 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [St. Tammany Parish Hospital
1202 S Tyler St
Covington, LA 70121]
3.Collection Date: Feb/5/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.7]
Not Done:
LNMT Low
[12.0]
High
[16.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [37.5]
Not Done:
LNMT Low
[37.0]
High
[48.5]
Unit
%
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811095
Page 70 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.03]
Not Done:
LNMT Low
[4.00]
High
[5.40]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [118]
Not Done:
LNMT Low
[150]
High
[350]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.11]
Not Done:
LNMT Low
[3.90]
High
[12.70]
Unit
/uL
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811096
Page 71 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.2]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811097
Page 72 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811098
Page 73 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 1.Feb/2/2021 Record Identifier: Systolic: Diastolic:
1  107  72 Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811099
Page 74 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 2.Feb/3/2021 Record Identifier: Systolic: Diastolic:
1  108  65 Repeating Pages
 3.Feb/4/2021 Record Identifier: Systolic: Diastolic:
1  116  58 Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811100
Page 75 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/2/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [107]
Diastolic: [72]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [114]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811101
Page 76 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/3/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [108]
Diastolic: [65]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in beats/minute: [68]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811102
Page 77 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/4/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [116]
Diastolic: [58]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [78]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811103
Page 78 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 1.Feb/2/2021 Record Identifier: Oxygen Saturation
1  91.0 Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811104
Page 79 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Date: Vital Signs Details Form Instance
 2.Feb/3/2021 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
 3.Feb/4/2021 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811105
Page 80 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/2/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [91.0]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811106
Page 81 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/3/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811107
Page 82 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/4/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811108
Page 83 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811109
Page 84 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811110
Page 85 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811111
Page 86 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811112
Page 87 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessment Form Instance
 1.Feb/2/2021  CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
Patchy infiltrates bilateral bases of lung
, no CM
 Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811113
Page 88 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Feb/2/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Patchy infiltrates bilateral bases of lung, no CM]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811114
Page 89 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/03/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811115
Page 90 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BRZXNM]
5.bSample ID [BRZXP1]
5.cSample ID [BR7X7W]
5.dSample ID [BR7X7X]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811116
Page 91 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811117
Page 92 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811118
Page 93 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811119
Page 94 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811120
Page 95 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811121
Page 96 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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 [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811122
Page 97 of 421
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811123
Page 98 of 421
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811124
Page 99 of 421
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811125
Page 100 of 421
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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[ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811126
Page 101 of 421
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811127
Page 102 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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: //
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811128
Page 103 of 421
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811129
Page 104 of 421
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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?
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811130
Page 105 of 421
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811131
Page 106 of 421
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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?
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811132
Page 107 of 421
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811133
Page 108 of 421
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811134
Page 109 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811135
Page 110 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811136
Page 111 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811137
Page 112 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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?
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811138
Page 113 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811139
Page 114 of 421
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811140
Page 115 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811141
Page 116 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811142
Page 117 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811143
Page 118 of 421
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811144
Page 119 of 421
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811145
Page 120 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811146
Page 121 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
Mar/3/2021
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811147
Page 122 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811148
Page 123 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
:Mar/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811149
Page 124 of 421
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811150
Page 125 of 421
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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.aSample ID [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811151
Page 126 of 421
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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.aSample ID [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811152
Page 127 of 421
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Incomplete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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?YES
Date of First Delay:
Feb/3/2021
Reason(s) for Temporary Delay of Vaccination
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
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?
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811153
Page 128 of 421
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811154
Page 129 of 421
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811155
Page 130 of 421
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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 [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811156
Page 131 of 421
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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?
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811157
Page 132 of 421
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811158
Page 133 of 421
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811159
Page 134 of 421
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811160
Page 135 of 421
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811161
Page 136 of 421
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811162
Page 137 of 421
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811163
Page 138 of 421
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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: [ ]
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811164
Page 139 of 421
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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/30/2020
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811165
Page 140 of 421
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811166
Page 141 of 421
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811167
Page 142 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-09-2020 16:25:16 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay all inclusion criteria met, no exclusion criteria
met
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811168
Page 143 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811169
Page 144 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Sep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811170
Page 145 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Sep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811171
Page 146 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Sep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811172
Page 147 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Sep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811173
Page 148 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Sep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811174
Page 149 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811175
Page 150 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811176
Page 151 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aSep-09-2020 16:38:33 (UTC-06:00) Central
Time (US & Canada)Neha Upadhyay patient not of chilbearing potential
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811177
Page 152 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Oct-02-2020 13:35:29 (UTC-06:00) Central
Time (US & Canada)menopause 2001
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811178
Page 153 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-02-2020 13:34:17 (UTC-06:00) Central
Time (US & Canada)menopause 2001
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811179
Page 154 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-02-2020 13:34:17 (UTC-06:00) Central
Time (US & Canada)menopause 2001
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811180
Page 155 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6.aOct-02-2020 13:34:17 (UTC-06:00) Central
Time (US & Canada)menopause 2001
Not Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811181
Page 156 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-04-2021 16:58:17 (UTC-06:00) Central
Time (US & Canada)James
McMullenNot Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811182
Page 157 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-04-2021 16:58:17 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811183
Page 158 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-04-2021 16:58:17 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811184
Page 159 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-04-2021 16:58:17 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811185
Page 160 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James
McMullenNot Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811186
Page 161 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Feb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811187
Page 162 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Feb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811188
Page 163 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Feb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811189
Page 164 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Feb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811190
Page 165 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Feb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811191
Page 166 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Feb-04-2021 17:02:49 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Done
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811192
Page 167 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormMar-03-2021 16:17:07 (UTC-06:00) Central
Time (US & Canada)James
McMullenNot Applicable
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811193
Page 168 of 421
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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
James
McMullen N/A Feb-01-2021 12:02:47 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Nov-09-2020 15:02:31 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JuliaGarcia-Diaz, 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.
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811194
Page 169 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-09-2020 16:23:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020 16:23:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811195
Page 170 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020 16:23:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/9/2020Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811196
Page 171 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020 16:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11471230Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020 16:23:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020 16:24:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-09-2020 16:24:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020 16:24:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
WHITEInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811197
Page 172 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-09-2020 16:24:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/9/2020Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811198
Page 173 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-09-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
COMPLETEDInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811199
Page 174 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-09-2020 16:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:intractable migrain
e without aura
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:26:43
(UTC-06:00) Central
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-10-2020 18:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Patricia
BancheroQuery 1: Closed Response satisfies
query
Sep-10-2020 16:33:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered no significant
change in therapy or
hospitalization for
worsening disease
occurred during
6wks prior to
enrollment.
Sep-10-2020 15:33:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Patricia
BancheroQuery 1: Opened GPDCLIN: Please
confirm if any
significant change
in therapy or
hospitalization for
worsening disease
occured for
intractable migraine
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811200
Page 175 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
during the 6weeks
prior to enrollment.
Sep-09-2020 16:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
intractable migraine without au
raInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-09-2020 16:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-09-2020 16:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-09-2020 16:27:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:hypertension
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811201
Page 176 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:27:05
(UTC-06:00) Central
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-09-2020 16:27:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-09-2020 16:27:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-09-2020 16:27:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-09-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:GERD
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811202
Page 177 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:27:27
(UTC-06:00) Central
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-09-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
GERDInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-09-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-09-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-09-2020 16:29:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histo
ry Term:Mild coronary art
ery disease
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811203
Page 178 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:29:02
(UTC-06:00) Central
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-09-2020 16:29:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Mild coronary artery diseaseInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-09-2020 16:29:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-09-2020 16:29:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-09-2020 16:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:chronic rhinit
is
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811204
Page 179 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:29:29
(UTC-06:00) Central
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-09-2020 16:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
chronic rhinitisInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-09-2020 16:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-09-2020 16:29:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-09-2020 16:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:factor V leiden
disorder
Start Date: UNK/UNK/201
4
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811205
Page 180 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:30:19
(UTC-06:00) Central
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-17-2020 19:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-16-2020 13:06:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered not exclusionary
per pi
Sep-13-2020 20:11:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: There is
a Med Hx entry of
Factor V Leiden
disorder, please
confirm if pt meets
exclusions criteria
#10.
Sep-09-2020 16:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
factor V leiden disorderInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-09-2020 16:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-09-2020 16:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811206
Page 181 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g
Date Location User Value Reason
Sep-09-2020 16:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Insomnia
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:30:57
(UTC-06:00) Central
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-09-2020 16:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
InsomniaInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-09-2020 16:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-09-2020 16:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.h
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811207
Page 182 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-09-2020 16:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Degenerative disc
disease,lumbar
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:31:27
(UTC-06:00) Central
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-09-2020 16:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Degenerative disc disease,lumb
arInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-09-2020 16:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-09-2020 16:31:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-09-2020 16:32:35 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811208
Page 183 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Numb
er:9
Medical History
Term:cervical radicul
opathy
Start Date: UNK/UNK/200
0
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:32:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:32:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
cervical radiculopathyInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-09-2020 16:32:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2000Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811209
Page 184 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.i Ongoing:
Date Location User Value Reason
Sep-09-2020 16:32:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-09-2020 16:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:right foot pai
n
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811210
Page 185 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.j Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
right foot painInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-09-2020 16:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-09-2020 16:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-09-2020 16:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:allergic to hydro
codone
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811211
Page 186 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.k Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
allergic to hydrocodoneInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-09-2020 16:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2000Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-09-2020 16:33:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-09-2020 16:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:allergic to oxyc
odone
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811212
Page 187 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.l Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
allergic to oxycodoneInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-09-2020 16:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-09-2020 16:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-09-2020 16:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:allergic doxyc
ycline
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811213
Page 188 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.m Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
allergic doxycyclineInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-09-2020 16:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-09-2020 16:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Sep-09-2020 16:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:14
Medical History T
erm:menopausal
Start Date: UNK/UNK/2
001
Ongoing: YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811214
Page 189 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.n Line/MH Number:
Date Location User Value Reason
Sep-09-2020 16:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 16:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
menopausalInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-09-2020 16:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
UNK/UNK/2001Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-09-2020 16:36:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811215
Page 190 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 16:39:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-09-2020 16:39:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 16:39:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/9/2020Transcription Error
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Collection Date,
09/Sep/2022 is a
future date relative
to when it was
entered on 09/Sep
/2020. Please
correct.
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs Date
09/Sep/2022 is not
same as Date of
Visit 09/Sep/2020.
Please review and
update as
appropriate or
clarify.
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/9/2022Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
226.0Initial Entry
3. Unit:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811216
Page 191 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.8Initial Entry
7.a
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811217
Page 192 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 16:37:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811218
Page 193 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811219
Page 194 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-09-2020 16:38:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Not ApplicableInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811220
Page 195 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020 16:39:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020 16:39:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
253202Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811221
Page 196 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 16:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 16:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 09:00:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 06:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-09-2020 16:39:46
(UTC-06:00) Central
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-09-2020 16:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811222
Page 197 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a
Date Location User Value Reason
Sep-10-2020 09:00:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLF4VInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 09:00:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLF4VInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020 09:00:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3DSInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020 09:00:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3DSInitial Entry
5.c
Date Location User Value Reason
Sep-10-2020 09:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3DTInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020 09:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3DTInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811223
Page 198 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d
Date Location User Value Reason
Sep-10-2020 09:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3DVInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-10-2020 09:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3DVInitial Entry
5.e
Date Location User Value Reason
Sep-10-2020 09:01:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLF4DInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-10-2020 09:01:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLF4DInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811224
Page 199 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 16:39:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 16:39:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 08:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 06:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-09-2020 16:39:57
(UTC-06:00) Central
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-09-2020 16:39:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811225
Page 200 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a
Date Location User Value Reason
Sep-10-2020 08:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3D6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 08:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3D6Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811226
Page 201 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
Sep/9/2020 13:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) CentralACV0PFEINFP6000  Neha Upadhyay Data Entry:
LEFTInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811227
Page 202 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-09-2020 16:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811228
Page 203 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-09-2020 16:41:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Neha Upadhyay Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811229
Page 204 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-02-2020 13:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811230
Page 205 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020 13:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2.a
Date Location User Value Reason
Oct-02-2020 13:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.6
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-02-2020 13:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-02-2020 13:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-02-2020 13:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811231
Page 206 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature Location:
Date Location User Value Reason
Oct-02-2020 13:32:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811232
Page 207 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
3. Collection Date:
Date Location User Value Reason
Oct-02-2020 13:35:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-02-2020 13:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-02-2020 13:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-02-2020 13:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-02-2020 13:34:17
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811233
Page 208 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
6.a Not Done:
Date Location User Value Reason
Oct-02-2020 13:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811234
Page 209 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 13:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 13:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 17:15:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 13:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 13:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 17:15:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sample ID: BR7XC3Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811235
Page 210 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 17:15:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
BR7XC3Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811236
Page 211 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 09:44Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811237
Page 212 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-02-2020 13:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811238
Page 213 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-30-2020 11:19:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
Oct/30/2020Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811239
Page 214 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 11:19:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 11:19:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 04:31:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 11:19:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 11:19:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Fredrick
OkworiData Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 04:31:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNV16Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811240
Page 215 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 04:31:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNV16Initial Entry
5.b
Date Location User Value Reason
Nov-02-2020 04:38:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNV1GInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 04:38:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNV1GInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 04:41:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7XM1Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 04:41:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7XM1Initial Entry
5.d
Date Location User Value Reason
Nov-02-2020 04:47:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7XM0Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811241
Page 216 of 421
***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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sample ID
Date Location User Value Reason
Nov-02-2020 04:47:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7XM0Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811242
Page 217 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 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-24-2021 04:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-23-2021 17:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Feb-16-2021 02:25:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Per comment 'Site
will update
self-swab when
available'. Please
verify if the swabs
details are available
& update the details
in corresponding
CRF. Thanks
Feb-03-2021 05:25:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Please update when
data is available.
Thank you.
Feb-02-2021 16:18:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenQuery 1: Answered Site will update
self-swab when
available.
Feb-02-2021 14:06:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Please complete the
data that is known
at this time and
update once
possible.
Feb-02-2021 08:57:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenQuery 1: Answered Site has not
received self swab
from the subject yet
Feb-02-2021 02:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811243
Page 218 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Swab are missing.
Please review and
update as
appropriate.
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-01-2021 12:02:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-01-2021 12:02:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Feb-01-2021 12:02:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Feb/1/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-01-2021 12:02:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811244
Page 219 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Feb/1/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Jan/29/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-03-2021 16:22:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESNew Information
Feb-22-2021 15:17:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NO
Date of Last Symptom Resolv
ed:
Feb/20/2021New Information
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811245
Page 220 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sympto NEW OR INCREASInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811246
Page 221 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
ms: ED SHORTNESS OF
BREATH
Sympto
m Prese
nt:YES
4.c Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811247
Page 222 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.e
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptom
s:NEW OR INCREA
SED MUSCLE PAI
N
Symptom
Present:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811248
Page 223 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.f Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.g
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sympto
ms:NEW OR INCREA
SED SORE THROA
T
Sympto
m Presen
t:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.h
Date Location User Value Reason
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811249
Page 224 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811250
Page 225 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
4.i Symptoms:
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YESInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811251
Page 226 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811252
Page 227 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-03-2021 05:30:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-02-2021 16:17:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenQuery 1: Answered Subject planned to
send results to site
but was admitted to
ER. Forms
updated.
Feb-02-2021 14:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please update the
Trade Name of the
sample per CCGs
section 8.31.4• If
the Trade Name is
not known, enter
“NALT Unknown”.
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Jan/30/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811253
Page 228 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-02-2021 16:17:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-02-2021 08:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-02-2021 16:17:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NALT UnknownInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811254
Page 229 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: 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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 17:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 17:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 17:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 17:15:42
(UTC-06:00) Central
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.
Feb-23-2021 17:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YES
Date of Collection:
Feb/22/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 17:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Sample ID: RW89794Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811255
Page 230 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: 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: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 17:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
RW89794Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811256
Page 231 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021 12:04:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021 12:04:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021 12:04:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-01-2021 12:04:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Site did not collect swabInitial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811257
Page 232 of 421
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Practitioner
:SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Practi
tioner:EMERGENC
Y ROOM
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
1Initial Entry
090177e196ae3d78\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811258
Page 233 of 421
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471230 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
Type of Practit
ioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  James
McMullenData Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-02-2021 08:35:40
(UTC-06:00) Central
Time (US & Canada)
…[truncated]