Document text
Page 1 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844138
Page 2 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844139
Page 3 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11661047]
2.Birth Date: /1970
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0844140
Page 4 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844141
Page 5 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844142
Page 6 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844143
Page 7 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Scoliosis]
Start Date: UNK/UNK/1980
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Flat feet]
Start Date: UNK/UNK/1980
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Left leg femoral artery repair]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Smoker]
Start Date: UNK/UNK/1988
Ongoing: YES
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844144
Page 8 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [60.7]
3.Unit: kg
4.Height: [177.3]
5.Unit: cm
6.Body Mass Index: [19.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844145
Page 9 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [74652]
3.Randomization Group: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844146
Page 10 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BL9ZWD]
5.bSample ID [BL9ZWF]
5.cSample ID [BL9ZWG]
5.dSample ID [BN6CGJ]
5.eSample ID [BN6CGK]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844147
Page 11 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BN669Z]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844148
Page 12 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: Aug/31/2020 14:56
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844149
Page 13 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844150
Page 14 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020 Comments
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844151
Page 15 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844152
Page 16 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
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:[Patient discontinued study.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844153
Page 17 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844154
Page 18 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020 Comments
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844155
Page 19 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[N/A pt discontinued; meant to enter CONVA_A visit.] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844156
Page 20 of 842
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844157
Page 21 of 842
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844158
Page 22 of 842
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844159
Page 23 of 842
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844160
Page 24 of 842
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844161
Page 25 of 842
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844162
Page 26 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844163
Page 27 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/22/2020
2.Date of First Symptom Started: Aug/31/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Aug/31/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
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
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844164
Page 28 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844165
Page 29 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844166
Page 30 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Specimen was taken IN-CLINIC because this started as a regular Visit #2; per
CRF/CRA instructions, all available data was used to create an illness visit instead.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844167
Page 31 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020Comments
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 [BN66DY]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844168
Page 32 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844169
Page 33 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844170
Page 34 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844171
Page 35 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Allergic reaction to vaccine #1]
Date of Diagnosis:
Sep/22/2020
3.Toxicity Grade: 1 Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844172
Page 36 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844173
Page 37 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844174
Page 38 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844175
Page 39 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844176
Page 40 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844177
Page 41 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844178
Page 42 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844179
Page 43 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable Not Applic
able Not Applic
able 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
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844180
Page 44 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844181
Page 45 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844182
Page 46 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844183
Page 47 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844184
Page 48 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844185
Page 49 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844186
Page 50 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844187
Page 51 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844188
Page 52 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844189
Page 53 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844190
Page 54 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844191
Page 55 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844192
Page 56 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844193
Page 57 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844194
Page 58 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844195
Page 59 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844196
Page 60 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844197
Page 61 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/13/2020
2.Date of First Symptom Started: Nov/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/14/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844198
Page 62 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descripti
onDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicabl
e Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844199
Page 63 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844200
Page 64 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [CV55797]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844201
Page 65 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:[Patient self-swab collected day of visit.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844202
Page 66 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844203
Page 67 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844204
Page 68 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844205
Page 69 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: 1
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844206
Page 70 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844207
Page 71 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844208
Page 72 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844209
Page 73 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844210
Page 74 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844211
Page 75 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844212
Page 76 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844213
Page 77 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable Not Applic
able Not Applic
able 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
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844214
Page 78 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844215
Page 79 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844216
Page 80 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844217
Page 81 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844218
Page 82 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844219
Page 83 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844220
Page 84 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844221
Page 85 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844222
Page 86 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844223
Page 87 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844224
Page 88 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844225
Page 89 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844226
Page 90 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844227
Page 91 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844228
Page 92 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844229
Page 93 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/13/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844230
Page 94 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844231
Page 95 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/19/2020
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [FATIGUE]
5.bSymptoms - Other Text: [SLIGHT WHEEZING]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844232
Page 96 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descripti
onDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicabl
e Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844233
Page 97 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844234
Page 98 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/22/2020
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 [CV44145]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844235
Page 99 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:[TELEHEALTH VISIT THUS IN-CLINIC SWAB N/A. PT DID COLLECT
SELF-SWAB (#CV44145) ON 12/22/2020 = DOV.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844236
Page 100 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844237
Page 101 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844238
Page 102 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844239
Page 103 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: 1
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844240
Page 104 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844241
Page 105 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844242
Page 106 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844243
Page 107 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844244
Page 108 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844245
Page 109 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844246
Page 110 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844247
Page 111 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable Not Applic
able Not Applic
able 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
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844248
Page 112 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844249
Page 113 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844250
Page 114 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844251
Page 115 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844252
Page 116 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844253
Page 117 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844254
Page 118 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844255
Page 119 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844256
Page 120 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844257
Page 121 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844258
Page 122 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844259
Page 123 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844260
Page 124 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844261
Page 125 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844262
Page 126 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844263
Page 127 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844264
Page 128 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/26/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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_A1
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844265
Page 129 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/26/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZKBV]
5.bSample ID [BNZKBW]
5.cSample ID [BNZKBX]
5.dSample ID [BLB01Y]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844266
Page 130 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Dec/11/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844267
Page 131 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/11/2020
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 [BNZKGV]
5.bSample ID [BNZKGW]
5.cSample ID [BNZKGX]
5.dSample ID [BLB038]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844268
Page 132 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled Visit
on Jan/21/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844269
Page 133 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCWXZ]
5.bSample ID [BRCWY0]
5.cSample ID [BRCWY1]
5.dSample ID [BLB04J]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844270
Page 134 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844271
Page 135 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844272
Page 136 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Aug/31/2020 Comments
2.Phase of Disposition: VACCINATION Comments
3.Status: ADVERSE EVENT Comments
4.Specify Status: [ ] Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844273
Page 137 of 842
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844274
Page 138 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844275
Page 139 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844276
Page 140 of 842
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1. DELETED ADVERSE EVE
NT 1 Subjective feve
r Aug/31/2020 15
:30 NO
End Date Time:
Aug/31/2020 17:30
Repeating
Pages
2. DELETED ADVERSE EVE
NT 2 Shortness of bre
ath Aug/31/2020 15
:30 NO
End Date Time:
Aug/31/2020 17:30
Repeating
Pages
3. ADVERSE EVE
NT 3 Dizziness Aug/31/2020 15
:30 NO
End Date Time:
Aug/31/2020 17:30
Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844277
Page 141 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Subjective fever ]
4.Start Date Time: Aug/31/2020 15:30
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 17:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844278
Page 142 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844279
Page 143 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Shortness of breath ]
4.Start Date Time: Aug/31/2020 15:30
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 17:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO Comments
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844280
Page 144 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844281
Page 145 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Dizziness]
4.Start Date Time: Aug/31/2020 15:30
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 17:30
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
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
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844282
Page 146 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844283
Page 147 of 842
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844284
Page 148 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844285
Page 149 of 842
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844286
Page 150 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844287
Page 151 of 842
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844288
Page 152 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844289
Page 153 of 842
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844290
Page 154 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844291
Page 155 of 842
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844292
Page 156 of 842
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844293
Page 157 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844294
Page 158 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844295
Page 159 of 842
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844296
Page 160 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844297
Page 161 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844298
Page 162 of 842
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844299
Page 163 of 842
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844300
Page 164 of 842
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844301
Page 165 of 842
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844302
Page 166 of 842
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844303
Page 167 of 842
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844304
Page 168 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/18/2021 Comments
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION Comments
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844305
Page 169 of 842
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844306
Page 170 of 842
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844307
Page 171 of 842
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844308
Page 172 of 842
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844309
Page 173 of 842
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844310
Page 174 of 842
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844311
Page 175 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/31/2020
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844312
Page 176 of 842
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844313
Page 177 of 842
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mary Beth
Manning Approved Mar-08-2021 18:55:00 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MaryBeth, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844314
Page 178 of 842
***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: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-01-2020 08:19:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844315
Page 179 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-28-2020 10:59:52 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Unable to remove date (required per query: remove
V2_VAX2 data because vaccine was withheld by
investigator).
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844316
Page 180 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-06-2020 15:26:50 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Patient did not receive vaccine #2 per patient's own
choice and d/c'd study. Study procedures do not
apply.
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844317
Page 181 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844318
Page 182 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844319
Page 183 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844320
Page 184 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844321
Page 185 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844322
Page 186 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844323
Page 187 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844324
Page 188 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844325
Page 189 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844326
Page 190 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844327
Page 191 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
10Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844328
Page 192 of 842
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
11Sep-24-2020 09:19:22 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0844329
Page 193 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-10-2020 09:58:12 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844330
Page 194 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-10-2020 09:57:59 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844331
Page 195 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-17-2020 09:19:58 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich
FormNov-10-2020 09:59:26 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844332
Page 196 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-17-2020 09:19:58 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich
1Nov-10-2020 09:59:26 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844333
Page 197 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Nov-17-2020 09:19:58 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich
2Nov-10-2020 09:59:26 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844334
Page 198 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-17-2020 09:19:58 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich
3Nov-10-2020 09:59:26 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
Not Applicable
3Nov-10-2020 09:59:14 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844335
Page 199 of 842
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Nov-17-2020 09:19:58 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich
4Nov-10-2020 09:59:26 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich N/A pt discontinued; meant to enter CONVA_A
visit.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844336
Page 200 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this
started as a regular Visit #2; per CRF/CRA
instructions, all available data was used to create an
illness visit instead. Thus no self-swab since done
in-clinic.
Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844337
Page 201 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
1Oct-09-2020 08:48:51 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844338
Page 202 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
2Oct-09-2020 08:49:06 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844339
Page 203 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
3Oct-09-2020 08:49:39 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich All available information inputted from V2 data.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844340
Page 204 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844341
Page 205 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844342
Page 206 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
6Oct-09-2020 08:49:53 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich All available information inputted from V2 data.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844343
Page 207 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
7Oct-09-2020 08:50:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich All available information inputted from V2 data.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844344
Page 208 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
8Oct-09-2020 08:50:23 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich All available information inputted from V2 data.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844345
Page 209 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Oct-28-2020 15:31:49 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Already done/all available information inputted.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Done
9Oct-09-2020 08:50:34 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich All available information inputted from V2 data.
Specimen was taken IN-CLINIC because this started
as a regular Visit #2; per CRF/CRA instructions, all
available data was used to create an illness visit
instead. Thus no self-swab since done in-clinic.
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844346
Page 210 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-13-2020 09:34:07 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Original value is correct: Patient was out of
window/no illness specific visit done because patient
did not contact clinic in time.
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844347
Page 211 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844348
Page 212 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844349
Page 213 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844350
Page 214 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844351
Page 215 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844352
Page 216 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Dec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844353
Page 217 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-26-2020 12:28:09 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844354
Page 218 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-13-2020 10:06:06 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Query will not close: AE amended to GRADE 1
and is now accurate. Please close all queries on this
form.
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844355
Page 219 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-13-2020 10:00:34 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Awaiting clarification from investigator.
3Oct-07-2020 13:18:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Awaiting clarification from investigator.
Unknown
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844356
Page 220 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-26-2020 12:28:41 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844357
Page 221 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-26-2020 12:28:41 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844358
Page 222 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-26-2020 12:28:41 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844359
Page 223 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-26-2020 12:28:41 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844360
Page 224 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-26-2020 12:28:41 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844361
Page 225 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844362
Page 226 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844363
Page 227 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844364
Page 228 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844365
Page 229 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844366
Page 230 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844367
Page 231 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844368
Page 232 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844369
Page 233 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844370
Page 234 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844371
Page 235 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844372
Page 236 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844373
Page 237 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844374
Page 238 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844375
Page 239 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844376
Page 240 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844377
Page 241 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844378
Page 242 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844379
Page 243 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844380
Page 244 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844381
Page 245 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844382
Page 246 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844383
Page 247 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844384
Page 248 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844385
Page 249 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844386
Page 250 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844387
Page 251 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844388
Page 252 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844389
Page 253 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844390
Page 254 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844391
Page 255 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844392
Page 256 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844393
Page 257 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-26-2020 12:29:03 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844394
Page 258 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-26-2020 12:29:25 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844395
Page 259 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-26-2020 12:29:25 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844396
Page 260 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-26-2020 12:29:25 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD OF
CARE PROCEDURES. THIS SITE DOES NOT
CONSIDER THIS TO BE SOC - THUS NOT
REQUIRED, PER PROTOCOL. THUS NOT
DONE, YET N/A IS MORE APPLICABLE
BECAUSE NOT REQUIRED (I.E., NOT
SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0d\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0844397
Page 261 of 842
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661047 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-26-2020 12:2
…[truncated]