125742 S1 M5 CRF c4591001 1178 11781164

Document text

Page 1 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817580
Page 2 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/14/2020
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817581
Page 3 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11781164]
2.Birth Date: 1958
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:
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0817582
Page 4 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817583
Page 5 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817584
Page 6 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817585
Page 7 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: Jan/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypercholesterolemia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817586
Page 8 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraine]
Start Date: UNK/UNK/2000
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[post menopausal]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2012
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[attention deficit disorder]
Start Date: UNK/UNK/2006
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2004
Ongoing: YES
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817587
Page 9 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [170.0]
3.Unit: LB
4.Height: [62.0]
5.Unit: in
6.Body Mass Index: [31.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817588
Page 10 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817589
Page 11 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [258896]
3.Randomization Group: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817590
Page 12 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY8L5]
5.bSample ID [BNWP7G]
5.cSample ID [BNWP7H]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817591
Page 13 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY8L4]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817592
Page 14 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/14/2020 11:31
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817593
Page 15 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817594
Page 16 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817595
Page 17 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817596
Page 18 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817597
Page 19 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW3N9]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817598
Page 20 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/5/2020 10:14
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817599
Page 21 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817600
Page 22 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BPW44K]
5.bSample ID [BRVDG3]
5.cSample ID [BRVDG4]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817601
Page 23 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817602
Page 24 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/23/2020
2.Date of First Symptom Started: Sep/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/26/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817603
Page 25 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [sinus pain]
5.bSymptoms - Other Text: [headache]
5.cSymptoms - Other Text: [nausea]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817604
Page 26 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Sep/28/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817605
Page 27 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/28/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817606
Page 28 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV05255]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817607
Page 29 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[subject used self-swab, telehealth visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817608
Page 30 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Not Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[Marshall testing facility]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817609
Page 31 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Not Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817610
Page 32 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done
 Not Done
 Not Done
 Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817611
Page 33 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817612
Page 34 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817613
Page 35 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817614
Page 36 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817615
Page 37 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817616
Page 38 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817617
Page 39 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817618
Page 40 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817619
Page 41 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817620
Page 42 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done
 Sponsor-Define
d IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817621
Page 43 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817622
Page 44 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817623
Page 45 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817624
Page 46 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817625
Page 47 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817626
Page 48 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817627
Page 49 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817628
Page 50 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817629
Page 51 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817630
Page 52 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817631
Page 53 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817632
Page 54 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817633
Page 55 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817634
Page 56 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817635
Page 57 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817636
Page 58 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817637
Page 59 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817638
Page 60 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/12/2020
2.Date of First Symptom Started: Oct/11/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/15/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817639
Page 61 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Bilateral Ear Ache]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817640
Page 62 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/22/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817641
Page 63 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/22/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT unknown] Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817642
Page 64 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [CV51008]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817643
Page 65 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV51008 ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817644
Page 66 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[Tennessee Department of Health]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817645
Page 67 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817646
Page 68 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Treatment Start DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817647
Page 69 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817648
Page 70 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 3
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817649
Page 71 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817650
Page 72 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817651
Page 73 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applica
ble Not App
licable Not Appl
icable Not App
licable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable
 C Reactive Protein
_PX329 Not App
licable 
Not Applicable
 Alanine Aminotra
nsferase_PX30 Not App
licable 
Not Applicable
 Aspartate Aminotr
ansferase_PX28 Not App
licable 
Not Applicable
 Alkaline Phosphat
ase_PX35 Not App
licable 
Not Applicable
 Bilirubin_PX21  Not App
licable 
Not Applicable
 Blood Urea Nitrog
en_PX47 Not App
licable 
Not Applicable
 Creatinine_PX48  Not App
licable Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817652
Page 74 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817653
Page 75 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817654
Page 76 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817655
Page 77 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817656
Page 78 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category fo
r Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicab
le Not Applicable  Not Appli
cable Not Appl
icable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817657
Page 79 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817658
Page 80 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817659
Page 81 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817660
Page 82 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817661
Page 83 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817662
Page 84 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817663
Page 85 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817664
Page 86 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817665
Page 87 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817666
Page 88 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817667
Page 89 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817668
Page 90 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817669
Page 91 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817670
Page 92 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817671
Page 93 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817672
Page 94 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817673
Page 95 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/27/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817674
Page 96 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BPW40X]
5.bSample ID [BRVDZS]
5.cSample ID [BRVDZT]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817675
Page 97 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/17/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817676
Page 98 of 670
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BR7GS6]
5.bSample ID [BRVDM1]
5.cSample ID [BRVDM2]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817677
Page 99 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817678
Page 100 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817679
Page 101 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817680
Page 102 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817681
Page 103 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817682
Page 104 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817683
Page 105 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  lymphadenopathy, rug
ht axilla Oct/14/2020
22:30 NO
End Date Time:
Oct/21/2020 10:30
 Repeating
Pages
 2.ADVERSE E
VENT 2  injection site tenderne
ss Jan/26/2021 1
8:00 NO
End Date Time:
Jan/28/2021 UNK:UN
K
 Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817684
Page 106 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[lymphadenopathy, rught axilla]
4.Start Date Time: Oct/14/2020 22:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/21/2020 10:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817685
Page 107 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817686
Page 108 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site tenderness]
4.Start Date Time: Jan/26/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/28/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817687
Page 109 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817688
Page 110 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817689
Page 111 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817690
Page 112 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817691
Page 113 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: //
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817692
Page 114 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817693
Page 115 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817694
Page 116 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817695
Page 117 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817696
Page 118 of 670
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817697
Page 119 of 670
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817698
Page 120 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817699
Page 121 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817700
Page 122 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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:
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817701
Page 123 of 670
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817702
Page 124 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817703
Page 125 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817704
Page 126 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817705
Page 127 of 670
***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, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817706
Page 128 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817707
Page 129 of 670
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817708
Page 130 of 670
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817709
Page 131 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817710
Page 132 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817711
Page 133 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817712
Page 134 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817713
Page 135 of 670
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817714
Page 136 of 670
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR7SFD]
5.bSample ID [BSGFL7]
5.cSample ID [BSGFL8]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817715
Page 137 of 670
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR7SFC]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817716
Page 138 of 670
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/26/2021 09:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817717
Page 139 of 670
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817718
Page 140 of 670
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817719
Page 141 of 670
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BR7SLM]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817720
Page 142 of 670
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/22/2021 14:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817721
Page 143 of 670
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817722
Page 144 of 670
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817723
Page 145 of 670
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817724
Page 146 of 670
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817725
Page 147 of 670
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817726
Page 148 of 670
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817727
Page 149 of 670
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817728
Page 150 of 670
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/9/2020
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817729
Page 151 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817730
Page 152 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0817731
Page 153 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-14-2020 11:21:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817732
Page 154 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817733
Page 155 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817734
Page 156 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817735
Page 157 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817736
Page 158 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817737
Page 159 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817738
Page 160 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817739
Page 161 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817740
Page 162 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aSep-14-2020 11:30:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817741
Page 163 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817742
Page 164 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817743
Page 165 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817744
Page 166 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817745
Page 167 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817746
Page 168 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817747
Page 169 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aOct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817748
Page 170 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aOct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817749
Page 171 of 670
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aOct-05-2020 11:01:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817750
Page 172 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
FormSep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0817751
Page 173 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
1Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817752
Page 174 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
2Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817753
Page 175 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
3Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817754
Page 176 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
4Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817755
Page 177 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
5Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817756
Page 178 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
6Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817757
Page 179 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
7Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817758
Page 180 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
8Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817759
Page 181 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Oct-06-2020 11:11:05 (UTC-06:00) Central
Time (US & Canada)
9Sep-23-2020 16:51:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817760
Page 182 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817761
Page 183 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817762
Page 184 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817763
Page 185 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817764
Page 186 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817765
Page 187 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817766
Page 188 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Sep-23-2020 16:52:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817767
Page 189 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:53:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817768
Page 190 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:53:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817769
Page 191 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:53:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817770
Page 192 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:53:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817771
Page 193 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-23-2020 16:53:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817772
Page 194 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817773
Page 195 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817774
Page 196 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817775
Page 197 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817776
Page 198 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817777
Page 199 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817778
Page 200 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817779
Page 201 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817780
Page 202 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817781
Page 203 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817782
Page 204 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817783
Page 205 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817784
Page 206 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817785
Page 207 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817786
Page 208 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817787
Page 209 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817788
Page 210 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817789
Page 211 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817790
Page 212 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817791
Page 213 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817792
Page 214 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817793
Page 215 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817794
Page 216 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817795
Page 217 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817796
Page 218 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817797
Page 219 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817798
Page 220 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817799
Page 221 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817800
Page 222 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817801
Page 223 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817802
Page 224 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817803
Page 225 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817804
Page 226 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817805
Page 227 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817806
Page 228 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817807
Page 229 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817808
Page 230 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817809
Page 231 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817810
Page 232 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817811
Page 233 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817812
Page 234 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817813
Page 235 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817814
Page 236 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817815
Page 237 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817816
Page 238 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817817
Page 239 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817818
Page 240 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817819
Page 241 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817820
Page 242 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817821
Page 243 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817822
Page 244 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817823
Page 245 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817824
Page 246 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817825
Page 247 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817826
Page 248 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817827
Page 249 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817828
Page 250 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817829
Page 251 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817830
Page 252 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817831
Page 253 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817832
Page 254 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817833
Page 255 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817834
Page 256 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817835
Page 257 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817836
Page 258 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817837
Page 259 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817838
Page 260 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817839
Page 261 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817840
Page 262 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817841
Page 263 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817842
Page 264 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817843
Page 265 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817844
Page 266 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817845
Page 267 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.iSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817846
Page 268 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817847
Page 269 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817848
Page 270 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817849
Page 271 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.jSep-23-2020 16:53:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817850
Page 272 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:54:01 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817851
Page 273 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:54:01 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817852
Page 274 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aSep-23-2020 16:54:01 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817853
Page 275 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aSep-23-2020 16:54:01 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817854
Page 276 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aSep-23-2020 16:54:01 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817855
Page 277 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aSep-23-2020 16:54:01 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817856
Page 278 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:54:15 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817857
Page 279 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:54:15 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817858
Page 280 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aSep-23-2020 16:54:15 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817859
Page 281 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:54:40 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817860
Page 282 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:54:40 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817861
Page 283 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:54:40 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817862
Page 284 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:54:40 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817863
Page 285 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817864
Page 286 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817865
Page 287 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817866
Page 288 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817867
Page 289 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817868
Page 290 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817869
Page 291 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Sep-23-2020 16:54:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817870
Page 292 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-23-2020 16:55:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817871
Page 293 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-23-2020 16:55:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817872
Page 294 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-23-2020 16:55:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817873
Page 295 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781164 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-23-2020 16:55:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3fb2\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0817874
Page 296 of 670
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Sep/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clin
…[truncated]