125742 S1 M5 CRF c4591001 1131 11311161

Document text

Page 1 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936916
Page 2 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936917
Page 3 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11311161]
2.Birth Date: 1984
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:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936918
Page 4 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936919
Page 5 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936920
Page 6 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936921
Page 7 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic rhinitis, seasonal]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[high blood pressure]
Start Date: UNK/UNK/2012
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[recurrent heartburn]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IBS-mixed]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936922
Page 8 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left kidney atrophy, congenital]
Start Date: UNK/UNK/1984
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[shingles with no post herpetic neuropathy]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/1998
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936923
Page 9 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nephrotic syndrome]
Start Date: UNK/UNK/1984
Ongoing: NO
End Date:
UNK/UNK/1986
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left kidney repair]
Start Date: UNK/UNK/1986
Ongoing: NO
End Date:
UNK/UNK/1986
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillectomy]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bunionectomy in right foot]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936924
Page 10 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [121.8]
3.Unit: kg
4.Height: [173.8]
5.Unit: cm
6.Body Mass Index: [40.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936925
Page 11 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/9/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936926
Page 12 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [85775]
3.Randomization Group: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936927
Page 13 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BL9W1C]
5.bSample ID [BP99P6]
5.cSample ID [BL9W1D]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936928
Page 14 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6F02]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936929
Page 15 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 18:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936930
Page 16 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936931
Page 17 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936932
Page 18 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936933
Page 19 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936934
Page 20 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BP9B34]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936935
Page 21 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/1/2020 17:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936936
Page 22 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936937
Page 23 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS7XBN]
5.bSample ID [BS7XBL]
5.cSample ID [BP99Z9]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936938
Page 24 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936939
Page 25 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/26/2020
2.Date of First Symptom Started: Oct/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? YES
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936940
Page 26 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headache]
5.bSymptoms - Other Text: [postnasal discharge]
5.cSymptoms - Other Text: [fatigue]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936941
Page 27 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/25/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936942
Page 28 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/25/2020 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: [Employee Health tested, and pending results;EDC will be updated
once results are known.]Comments
9.Trade Name Other, Specify: [NALT unknown] Comments
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936943
Page 29 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/26/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Home nasal swab to be delivered]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV16306]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936944
Page 30 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:[Home nasal swab will be delivered]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936945
Page 31 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936946
Page 32 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936947
Page 33 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936948
Page 34 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936949
Page 35 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936950
Page 36 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936951
Page 37 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936952
Page 38 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936953
Page 39 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936954
Page 40 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936955
Page 41 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936956
Page 42 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d 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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936957
Page 43 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936958
Page 44 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936959
Page 45 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936960
Page 46 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936961
Page 47 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936962
Page 48 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936963
Page 49 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936964
Page 50 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936965
Page 51 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936966
Page 52 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936967
Page 53 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936968
Page 54 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936969
Page 55 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936970
Page 56 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936971
Page 57 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936972
Page 58 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936973
Page 59 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936974
Page 60 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/17/2020
2.Date of First Symptom Started: Dec/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/2/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? 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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936975
Page 61 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [vertigo]
5.bSymptoms - Other Text: [nasal drainage]
5.cSymptoms - Other Text: [headache]
5.dSymptoms - Other Text: [chest tightness]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936976
Page 62 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable
 Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936977
Page 63 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936978
Page 64 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject does not have swab kit, plan to drive to office to do swab]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR10646]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936979
Page 65 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 does not have swab kit, plan to drive to office to do swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936980
Page 66 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936981
Page 67 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936982
Page 68 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936983
Page 69 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936984
Page 70 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936985
Page 71 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936986
Page 72 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936987
Page 73 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936988
Page 74 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936989
Page 75 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936990
Page 76 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936991
Page 77 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d 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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936992
Page 78 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936993
Page 79 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936994
Page 80 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936995
Page 81 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936996
Page 82 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936997
Page 83 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936998
Page 84 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936999
Page 85 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937000
Page 86 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937001
Page 87 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937002
Page 88 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937003
Page 89 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937004
Page 90 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937005
Page 91 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937006
Page 92 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937007
Page 93 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937008
Page 94 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937009
Page 95 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BS7XHR]
5.bSample ID [BS7XHP]
5.cSample ID [BR0F2N]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937010
Page 96 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/15/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937011
Page 97 of 653
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/15/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/15/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS7XRW]
5.bSample ID [BR0F7M]
5.cSample ID [BS7XRX]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937012
Page 98 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937013
Page 99 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937014
Page 100 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937015
Page 101 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937016
Page 102 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937017
Page 103 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937018
Page 104 of 653
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  fatigue  Sep/10/2020 U
NK:UNK NO
End Date Time:
Sep/12/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  injection site pain  Jan/5/2021 19:
30 NO
End Date Time:
Jan/8/2021 UNK:U
NK
 Repeating
Pages
 3.ADVERSE
EVENT 3  body aches  Jan/25/2021 U
NK:UNK NO
End Date Time:
Jan/27/2021 UNK:
UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  lymph node swelling right axillar
y and supra-clavicular Jan/28/2021 U
NK:UNK NO
End Date Time:
Feb/1/2021 UNK:U
NK
 Repeating
Pages
 5.ADVERSE
EVENT 5  low grade temperature elevation (
99.9) Jan/25/2021 19
:00 NO
End Date Time:
Jan/27/2021 UNK:
UNK
 Repeating
Pages
 6.ADVERSE
EVENT 6  headache  Jan/25/2021 19
:00 NO
End Date Time:
Jan/27/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937019
Page 105 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[fatigue]
4.Start Date Time: Sep/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/12/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937020
Page 106 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937021
Page 107 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 pain]
4.Start Date Time: Jan/5/2021 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/8/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937022
Page 108 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937023
Page 109 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[body aches]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937024
Page 110 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937025
Page 111 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[lymph node swelling right axillary and supra-clavicular]
4.Start Date Time: Jan/28/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/1/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937026
Page 112 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937027
Page 113 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[low grade temperature elevation (99.9)]
4.Start Date Time: Jan/25/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937028
Page 114 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937029
Page 115 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache]
4.Start Date Time: Jan/25/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937030
Page 116 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937031
Page 117 of 653
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937032
Page 118 of 653
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937033
Page 119 of 653
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicati
onStart Da
teForm Instanc
e
 1.1  VACCINATION
S NO  influenza vaccine, 0
.5ml, IM Oct/16/2
020 Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937034
Page 120 of 653
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[influenza vaccine, 0.5ml, IM]
5.Date: Oct/16/2020
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937035
Page 121 of 653
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937036
Page 122 of 653
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937037
Page 123 of 653
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937038
Page 124 of 653
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937039
Page 125 of 653
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937040
Page 126 of 653
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937041
Page 127 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937042
Page 128 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937043
Page 129 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937044
Page 130 of 653
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937045
Page 131 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937046
Page 132 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937047
Page 133 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937048
Page 134 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937049
Page 135 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937050
Page 136 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/5/2021
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937051
Page 137 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937052
Page 138 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/5/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937053
Page 139 of 653
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/5/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937054
Page 140 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
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 [BR0F69]
5.bSample ID [BS7XP7]
5.cSample ID [BS7XP8]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937055
Page 141 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
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 [BP9B8X]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937056
Page 142 of 653
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/5/2021 09:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937057
Page 143 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/22/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937058
Page 144 of 653
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937059
Page 145 of 653
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937060
Page 146 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937061
Page 147 of 653
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/25/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937062
Page 148 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9BBV]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937063
Page 149 of 653
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 08:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937064
Page 150 of 653
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937065
Page 151 of 653
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/24/2021
3.Comments: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937066
Page 152 of 653
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937067
Page 153 of 653
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937068
Page 154 of 653
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937069
Page 155 of 653
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937070
Page 156 of 653
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/24/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937071
Page 157 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/2/2020
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937072
Page 158 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937073
Page 159 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0937074
Page 160 of 653
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-09-2020 18:47:46 (UTC-05:00) Eastern
Time (US & Canada)no inclusion or exclusion criteria met
Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937075
Page 161 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937076
Page 162 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937077
Page 163 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937078
Page 164 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937079
Page 165 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937080
Page 166 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
5Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937081
Page 167 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Oct-27-2020 11:34:06 (UTC-05:00) Eastern
Time (US & Canada)
6Oct-26-2020 12:46:23 (UTC-05:00) Eastern
Time (US & Canada)Unknown
6Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
6Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937082
Page 168 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
7Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937083
Page 169 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
8Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
8Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4), (b) (6)
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Oct-26-2020 12:44:54 (UTC-05:00) Eastern
Time (US & Canada)
9Oct-26-2020 12:40:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937085
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
FormDec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937086
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937088
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
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Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Dec-17-2020 10:58:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937092
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Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 10:59:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 10:59:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 10:59:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937095
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
3Dec-17-2020 10:59:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-17-2020 10:59:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937097
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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FormDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937100
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937101
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937102
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937103
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937104
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.aDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937105
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0937106
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0937107
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0937108
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0937110
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0937111
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0937112
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4)
FDA-CBER-2021-5683-0937113
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937114
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937115
Page 201 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0937117
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.dDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937118
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.eDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937119
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937120
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937121
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937122
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937123
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937124
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937125
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937126
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937127
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937128
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937129
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937130
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937131
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937132
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937133
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937134
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937135
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937136
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937137
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937138
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937139
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937140
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937141
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937142
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937143
Page 229 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937144
Page 230 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937145
Page 231 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937146
Page 232 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937147
Page 233 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937148
Page 234 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937149
Page 235 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937150
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937151
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937152
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937153
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937154
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937155
Page 241 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937156
Page 242 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937157
Page 243 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937158
Page 244 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937159
Page 245 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937160
Page 246 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937161
Page 247 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937162
Page 248 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937163
Page 249 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937164
Page 250 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937165
Page 251 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937166
Page 252 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937167
Page 253 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937168
Page 254 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937169
Page 255 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937170
Page 256 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937171
Page 257 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937172
Page 258 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937173
Page 259 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937174
Page 260 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-17-2020 10:59:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937175
Page 261 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 11:00:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937176
Page 262 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 11:00:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937177
Page 263 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aDec-17-2020 11:00:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937178
Page 264 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aDec-17-2020 11:00:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937179
Page 265 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aDec-17-2020 11:00:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937180
Page 266 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aDec-17-2020 11:00:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937181
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 11:00:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937182
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 11:00:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937183
Page 269 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2.aDec-17-2020 11:00:34 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937184
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 11:00:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937185
Page 271 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 11:00:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937186
Page 272 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 11:00:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937187
Page 273 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-17-2020 11:00:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937188
Page 274 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937189
Page 275 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937190
Page 276 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937191
Page 277 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937192
Page 278 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937193
Page 279 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937194
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Dec-17-2020 11:01:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937195
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 11:01:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937196
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 11:01:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937197
Page 283 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/26/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 11:01:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937198
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-17-2020 11:01:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937199
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-17-2020 11:01:30 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937200
Page 286 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
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Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-17-2020 11:08:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937201
Page 287 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-17-2020 11:08:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937202
Page 288 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-17-2020 11:08:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0937203
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-17-2020 11:08:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937204
Page 290 of 653
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311161 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-17-2020 11:08:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eaa\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0937205
Page 291 of 653
***Confidential***
H
…[truncated]