125742 S1 M5 CRF c4591001 1166 11661078

Document text

Page 1 of 365
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 11661078 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844980
Page 2 of 365
***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: 11661078 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
Sep/15/2020
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844981
Page 3 of 365
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11661078]
2.Birth Date: /1977
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0844982
Page 4 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844983
Page 5 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844984
Page 6 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844985
Page 7 of 365
***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: 11661078 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:[C-section]
Start Date: Apr/15/2020
Ongoing: NO
End Date:
Apr/15/2020
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844986
Page 8 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844987
Page 9 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [102.5]
3.Unit: kg
4.Height: [165.3]
5.Unit: cm
6.Body Mass Index: [37.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844988
Page 10 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844989
Page 11 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [90631]
3.Randomization Group: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844990
Page 12 of 365
***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: 11661078 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:
Sep/15/2020
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 [BNZK65]
5.bSample ID [BNZK66]
5.cSample ID [BNZK67]
5.dSample ID [BL9ZYY]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844991
Page 13 of 365
***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: 11661078 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/15/2020
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 [BN66D8]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844992
Page 14 of 365
***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: 11661078 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: Sep/15/2020 15:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844993
Page 15 of 365
***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: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844994
Page 16 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020 Comments
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844995
Page 17 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844996
Page 18 of 365
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844997
Page 19 of 365
***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: 11661078 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:
Oct/5/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZK6K]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844998
Page 20 of 365
***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: 11661078 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: Oct/5/2020 13:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0844999
Page 21 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845000
Page 22 of 365
***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: 11661078 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:
Nov/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZKDF]
5.bSample ID [BNZKDG]
5.cSample ID [BNZKDH]
5.dSample ID [BLB02G]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845001
Page 23 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845002
Page 24 of 365
***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: 11661078 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 [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845003
Page 25 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845004
Page 26 of 365
***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: 11661078 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 [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845005
Page 27 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845006
Page 28 of 365
***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: 11661078 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 [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845007
Page 29 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845008
Page 30 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/28/2020
2.Date of First Symptom Started: Dec/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/26/2020Comments
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? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845009
Page 31 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Symptoms - Other
5.aSymptoms - Other Text: [BODY ACHES]
5.bSymptoms - Other Text: [FATIGUE]
5.cSymptoms - Other Text: [HEADACHE]
5.dSymptoms - Other Text: [RUNNY NOSE]
5.eSymptoms - Other Text: [NASAL CONGESTION]
5.fSymptoms - Other Text: [NAUSEA]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845010
Page 32 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845011
Page 33 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845012
Page 34 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 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:[PATIENT FAILED TO SEND DESPITE 3+ CONTACT ATTEMPTS AND
MESSAGES. PT LATER AGREED TO SWAB - BUT NEVER SENT. ALSO
CONTACTED EMERGENCY PERSON 1X.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845013
Page 35 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 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:[PT NOT SEEN IN-CLINIC (TELEHEALTH VISIT), THUS NO IN-CLINIC
SWAB TO REPORT/NOT APPLICABLE.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845014
Page 36 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845015
Page 37 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845016
Page 38 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845017
Page 39 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845018
Page 40 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845019
Page 41 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845020
Page 42 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Appli
cable 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 Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845021
Page 43 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845022
Page 44 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845023
Page 45 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845024
Page 46 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845025
Page 47 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845026
Page 48 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845027
Page 49 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845028
Page 50 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845029
Page 51 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845030
Page 52 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845031
Page 53 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845032
Page 54 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845033
Page 55 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845034
Page 56 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845035
Page 57 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845036
Page 58 of 365
***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: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845037
Page 59 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845038
Page 60 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845039
Page 61 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845040
Page 62 of 365
***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: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845041
Page 63 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845042
Page 64 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845043
Page 65 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: 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: 11661078 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:
Feb/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCX0M]
5.bSample ID [BRCX0N]
5.cSample ID [BRCX0P]
5.dSample ID [BLB05F]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845044
Page 66 of 365
***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: 11661078 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:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845045
Page 67 of 365
***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: 11661078 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 [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845046
Page 68 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845047
Page 69 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845048
Page 70 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  EXPOSURE DURING PR
EGNANCY Dec/18/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845049
Page 71 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
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)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Dec/18/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[EXPOSURE DURING PREGNANCY]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845050
Page 72 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845051
Page 73 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845052
Page 74 of 365
***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: 11661078 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[ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845053
Page 75 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
 1. DELETED           Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845054
Page 76 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
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).[ ] Comments
5.Date: //
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845055
Page 77 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845056
Page 78 of 365
***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: 11661078 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?
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845057
Page 79 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845058
Page 80 of 365
***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: 11661078 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?
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845059
Page 81 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845060
Page 82 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845061
Page 83 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845062
Page 84 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845063
Page 85 of 365
***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: 11661078 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:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845064
Page 86 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845065
Page 87 of 365
***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: 11661078 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?
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845066
Page 88 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845067
Page 89 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845068
Page 90 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845069
Page 91 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845070
Page 92 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11661078 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 [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845071
Page 93 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11661078 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 [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845072
Page 94 of 365
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845073
Page 95 of 365
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845074
Page 96 of 365
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 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 NOT willing to return for Vaccination 3 OR otherwise
not eligibleComments
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845075
Page 97 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for Unblinding: OTHER
If other, specify:
[subj is SAE sunj and will not be able to receive vacc but still wished to be
unblinded]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845076
Page 98 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845077
Page 99 of 365
***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: 11661078 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: [ ]
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845078
Page 100 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/2/2020
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845079
Page 101 of 365
***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: 11661078 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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845080
Page 102 of 365
***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: 11661078 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 19:04:21 (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.
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845081
Page 103 of 365
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-16-2020 09:23:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845082
Page 104 of 365
***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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-06-2020 08:35:24 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Note re e-Diary: Pt erroneously reported
ALLERGY sxs, NOT COVID-19 sxs. Please
disregard any such entries in e-diary, per CRC on
05-OCT-2020.
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845083
Page 105 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Not Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-06-2021 20:06:04 (UTC-05:00) Eastern
Time (US & Canada)Cory Kozlovich PENDING CRC CLARIFICATION: NO END
DATES FOR MANUALLY-ADDED AEs (I.E.,
AEs NOT ON THE eCRF BUT ONES
REQUIRING MANUAL, LINE-ITEM ENTRY
DO NOT APPEAR TO HAVE END DATES
PER SOURCE).
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845084
Page 106 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845085
Page 107 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845086
Page 108 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845087
Page 109 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845088
Page 110 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845089
Page 111 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845090
Page 112 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845091
Page 113 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845092
Page 114 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845093
Page 115 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Jan-15-2021 15:46:58 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845094
Page 116 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:52:12 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845095
Page 117 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-15-2021 15:52:12 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845096
Page 118 of 365
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Back to Form
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Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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ItemDate User Comment
5.cJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
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Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fJan-15-2021 15:53:15 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:53:57 (UTC-05:00) Eastern
Time (US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
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090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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ItemDate User Comment
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Back to Form
ItemDate User Comment
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ItemDate User Comment
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ItemDate User Comment
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ItemDate User Comment
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ItemDate User Comment
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Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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Back to Form
ItemDate User Comment
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Subject No: 11661078 Subject Initials: ---
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Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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Back to Form
ItemDate User Comment
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ItemDate User Comment
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ItemDate User Comment
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Back to Form
ItemDate User Comment
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Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Site No: 1166 Site Name: (1166) Rapid Medical Research
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Back to Form
ItemDate User Comment
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Site No: 1166 Site Name: (1166) Rapid Medical Research
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Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
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ItemDate User Comment
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Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
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ItemDate User Comment
5 fJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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ItemDate User Comment
5 fJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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5.gJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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5.gJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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5 hJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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5 hJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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Back to Form
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5 hJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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Subject No: 11661078 Subject Initials: ---
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Back to Form
ItemDate User Comment
5 hJan-15-2021 15:53:57 (UTC-05:00) Eastern Time
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Back to Form
ItemDate User Comment
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(US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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Back to Form
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Time (US & Canada)Cory Kozlovich PROTOCOL ONLY REQUIRES STANDARD
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Subject No: 11661078 Subject Initials: ---
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Back to Form
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Subject No: 11661078 Subject Initials: ---
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(I.E., NOT SKIPPED/MISSED AS IN "ND").
Not Applicable
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845188
Page 210 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aJan-15-2021 15:54:15 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845189
Page 211 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aJan-15-2021 15:54:15 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845190
Page 212 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:54:33 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845191
Page 213 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-15-2021 15:54:33 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845192
Page 214 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aJan-15-2021 15:54:33 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845193
Page 215 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: OXYGENATION PARAMETERS - 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:54:52 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845194
Page 216 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: OXYGENATION PARAMETERS - 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-15-2021 15:54:52 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845195
Page 217 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: OXYGENATION PARAMETERS - 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-15-2021 15:54:52 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845196
Page 218 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: OXYGENATION PARAMETERS - 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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-15-2021 15:54:52 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845197
Page 219 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845198
Page 220 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845199
Page 221 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845200
Page 222 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845201
Page 223 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845202
Page 224 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Jan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845203
Page 225 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Jan-15-2021 15:55:09 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845204
Page 226 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-15-2021 15:55:30 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845205
Page 227 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-15-2021 15:55:30 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845206
Page 228 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-15-2021 15:55:30 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845207
Page 229 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-15-2021 15:55:30 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845208
Page 230 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Jan-15-2021 15:55:30 (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
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845209
Page 231 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-04-2021 10:18:11 (UTC-05:00) Eastern
Time (US & Canada)Cory Kozlovich GRADE NOT APPLICABLE PER
PROTOCOL (SECTION 8.50.2.5/8.3.5.1).
FormDec-30-2020 10:24:05 (UTC-05:00) Eastern
Time (US & Canada)Cory Kozlovich GRADE NOT APPLICABLE PER
PROTOCOL (SECTION 8.50.2.5).
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845210
Page 232 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-30-2020 10:14:32 (UTC-05:00) Eastern
Time (US & Canada)Cory Kozlovich GRADE NOT APPLICABLE PER PROTOCOL
(SECTION 8.50.2.5).
Not Applicable
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845211
Page 233 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Oct-06-2020 08:41:45 (UTC-05:00) Eastern Time
(US & Canada)Cory Kozlovich Awaiting clarification of dose: LOESTRIN FE
brand is available as 1.5/30 AND 1/20.
Requested CRC to clarify w/pt on 06-OCT-2020.
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845212
Page 234 of 365
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Feb-26-2021 14:03:35 (UTC-05:00) Eastern
Time (US & Canada)Cory Kozlovich PARTICIPANT NOT ELIGIBLE DUE TO
SAE/EXPOSURE DURING PREGNANCY.
PARTICIPANT IS CONFIRMED PREGNANT
AND THUS NOT ELIGIBLE FOR REVAX.
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845213
Page 235 of 365
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
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 19:04:21 (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.
 N/A Mar-05-2021 09:06:00 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mary Beth
Manning Approved Mar-03-2021 20:29:58 (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.
Cory Kozlovich  N/A Feb-15-2021 11:54:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mary Beth
Manning Approved Jan-21-2021 12:44:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0845214
Page 236 of 365
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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.
Cory Kozlovich  N/A Dec-30-2020 10:07:27 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mary Beth
Manning Approved Nov-11-2020 12:27:46 (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.
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845215
Page 237 of 365
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020 09:22:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-16-2020 09:22:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845216
Page 238 of 365
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020 09:23:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/15/2020Initial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845217
Page 239 of 365
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
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: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020 09:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11661078Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020 09:22:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1977Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020 09:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020 09:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020 09:23:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845218
Page 240 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 10:35:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed per response
reported in error.
Oct-07-2020 08:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Cory Kozlovich Query 1: Answered Patient reported
erroneously, please
delete answer: this
was an allergy
symptom ONLY
and not related to
IP. CRC re-educated
pt on e-diary use for
COVID-19 sxs
only.
Oct-07-2020 06:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
02OCT2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Sep-16-2020 09:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0845219
Page 241 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-16-2020 09:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 09:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020 09:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845220
Page 242 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 09:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:C-section
Start Date: Apr/15/2020
Ongoing: NO
End Date:
Apr/15/20
20Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 09:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
C-sectionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 09:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/15/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 09:34:54
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845221
Page 243 of 365
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) End Date:
Apr/15/2020
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0845222
Page 244 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-16-2020 09:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845223
Page 245 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
102.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
165.3Initial Entry
5. Unit:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.5Initial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845224
Page 246 of 365
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.5
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 09:28:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845225
Page 247 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Medical Research
Subject No: 11661078 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 09:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020 09:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 09:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 09:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020 09:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020 09:27:54
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3d0e\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0845226
Page 248 of 365
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1166 Site Name: (1166) Rapid Med
…[truncated]