Document text
Page 1 of 343
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979536
Page 2 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979537
Page 3 of 343
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11161160]
2.Birth Date: /1972
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979538
Page 4 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979539
Page 5 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979540
Page 6 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979541
Page 7 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979542
Page 8 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [205.0]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [27.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979543
Page 9 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [84922]
3.Randomization Group: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979544
Page 10 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN65G5]
5.bSample ID [BN65G6]
5.cSample ID [BLBFJ3]
5.dSample ID [BLBFJ4]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979545
Page 11 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN65PS]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979546
Page 12 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 09:48
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
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979547
Page 13 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979548
Page 14 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979549
Page 15 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979550
Page 16 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BP4159]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979551
Page 17 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/28/2020 15:55
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
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979552
Page 18 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979553
Page 19 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP412H]
5.bSample ID [BP412G]
5.cSample ID [BNNRVJ]
5.dSample ID [BNNRVK]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979554
Page 20 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979555
Page 21 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/13/2021
2.Date of First Symptom Started: Jan/8/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979556
Page 22 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979557
Page 23 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/13/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979558
Page 24 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/13/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979559
Page 25 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:[COLLECTED IN CLINIC]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979560
Page 26 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BP40XJ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979561
Page 27 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [COUNTY HEALTH DEPARTMENT]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979562
Page 28 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done
Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979563
Page 29 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979564
Page 30 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Jan/13/2021
3.Toxicity Grade: 1
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979565
Page 31 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979566
Page 32 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979567
Page 33 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979568
Page 34 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979569
Page 35 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979570
Page 36 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979571
Page 37 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979572
Page 38 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979573
Page 39 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979574
Page 40 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979575
Page 41 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979576
Page 42 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979577
Page 43 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979578
Page 44 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979579
Page 45 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Jan/13/2021 Record Identifier: Systolic: Diastolic:
1 129 78 Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979580
Page 46 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/13/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [129]
Diastolic: [78]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [89]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979581
Page 47 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Jan/13/2021 Record Identifier: Oxygen Saturation
1 93.0 Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979582
Page 48 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/13/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979583
Page 49 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979584
Page 50 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979585
Page 51 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979586
Page 52 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979587
Page 53 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979588
Page 54 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979589
Page 55 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/17/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979590
Page 56 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
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 [BRJ01K]
5.bSample ID [BRJ01L]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979591
Page 57 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979592
Page 58 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979593
Page 59 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979594
Page 60 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979595
Page 61 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979596
Page 62 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979597
Page 63 of 343
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yAE Identifi
erAdverse Eve
ntStart Dat
eIs the Adverse Event Still Ong
oingForm Instance
1. DELETED Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979598
Page 64 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979599
Page 65 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979600
Page 66 of 343
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979601
Page 67 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979602
Page 68 of 343
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979603
Page 69 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979604
Page 70 of 343
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979605
Page 71 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979606
Page 72 of 343
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979607
Page 73 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979608
Page 74 of 343
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979609
Page 75 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979610
Page 76 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979611
Page 77 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979612
Page 78 of 343
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979613
Page 79 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979614
Page 80 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979615
Page 81 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979616
Page 82 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979617
Page 83 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979618
Page 84 of 343
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979619
Page 85 of 343
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979620
Page 86 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979621
Page 87 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/1/2021
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979622
Page 88 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979623
Page 89 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Mar/1/2021 Comments
2.Phase of Disposition: REPEAT SCREENING 1 Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979624
Page 90 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BRJ04D]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979625
Page 91 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BRJ05X]
5.bSample ID [BRJ05Y]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979626
Page 92 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/1/2021 09:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979627
Page 93 of 343
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979628
Page 94 of 343
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979629
Page 95 of 343
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979630
Page 96 of 343
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979631
Page 97 of 343
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979632
Page 98 of 343
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979633
Page 99 of 343
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979634
Page 100 of 343
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979635
Page 101 of 343
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979636
Page 102 of 343
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979637
Page 103 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979638
Page 104 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979639
Page 105 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Matherne Approved Mar-12-2021 12:12:16 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979640
Page 106 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-09-2020 10:30:43 (UTC-06:00) Central
Time (US & Canada)Heather
LambertNot Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979641
Page 107 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-09-2020 10:31:21 (UTC-06:00) Central
Time (US & Canada)Heather
LambertNot Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979642
Page 108 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979643
Page 109 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979644
Page 110 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979645
Page 111 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979646
Page 112 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979647
Page 113 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Jan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979648
Page 114 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Jan-26-2021 10:27:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979649
Page 115 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:28:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979650
Page 116 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:28:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979651
Page 117 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:28:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979652
Page 118 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:28:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979653
Page 119 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-26-2021 10:28:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979654
Page 120 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979655
Page 121 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979656
Page 122 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979657
Page 123 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979658
Page 124 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979659
Page 125 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979660
Page 126 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979661
Page 127 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979662
Page 128 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979663
Page 129 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979664
Page 130 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979665
Page 131 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979666
Page 132 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979667
Page 133 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979668
Page 134 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979669
Page 135 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979670
Page 136 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979671
Page 137 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979672
Page 138 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979673
Page 139 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979674
Page 140 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979675
Page 141 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979676
Page 142 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979677
Page 143 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979678
Page 144 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979679
Page 145 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979680
Page 146 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979681
Page 147 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979682
Page 148 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979683
Page 149 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979684
Page 150 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979685
Page 151 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979686
Page 152 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979687
Page 153 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979688
Page 154 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979689
Page 155 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979690
Page 156 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979691
Page 157 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979692
Page 158 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979693
Page 159 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979694
Page 160 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979695
Page 161 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979696
Page 162 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979697
Page 163 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979698
Page 164 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979699
Page 165 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979700
Page 166 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979701
Page 167 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979702
Page 168 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979703
Page 169 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979704
Page 170 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979705
Page 171 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979706
Page 172 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979707
Page 173 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979708
Page 174 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979709
Page 175 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979710
Page 176 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979711
Page 177 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979712
Page 178 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979713
Page 179 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979714
Page 180 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979715
Page 181 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979716
Page 182 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979717
Page 183 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979718
Page 184 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979719
Page 185 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979720
Page 186 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979721
Page 187 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979722
Page 188 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979723
Page 189 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979724
Page 190 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979725
Page 191 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979726
Page 192 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979727
Page 193 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979728
Page 194 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979729
Page 195 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979730
Page 196 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979731
Page 197 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jJan-26-2021 10:29:42 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979732
Page 198 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:32:07 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979733
Page 199 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:32:07 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979734
Page 200 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:32:07 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979735
Page 201 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:32:07 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979736
Page 202 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979737
Page 203 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979738
Page 204 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979739
Page 205 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979740
Page 206 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979741
Page 207 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Jan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979742
Page 208 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Jan-26-2021 10:32:24 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979743
Page 209 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-26-2021 10:32:44 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979744
Page 210 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-26-2021 10:32:44 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979745
Page 211 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-26-2021 10:32:44 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979746
Page 212 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-26-2021 10:32:44 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979747
Page 213 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-26-2021 10:32:44 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979748
Page 214 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormMar-04-2021 15:28:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979749
Page 215 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormMar-08-2021 09:28:49 (UTC-06:00) Central
Time (US & Canada)
FormMar-04-2021 15:28:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979750
Page 216 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Mar-08-2021 09:28:49 (UTC-06:00) Central
Time (US & Canada)
1Mar-04-2021 15:28:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979751
Page 217 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Mar-08-2021 09:28:49 (UTC-06:00) Central
Time (US & Canada)
2Mar-04-2021 15:28:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979752
Page 218 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Mar-08-2021 09:28:49 (UTC-06:00) Central
Time (US & Canada)
3Mar-04-2021 15:28:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979753
Page 219 of 343
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Mar-08-2021 09:28:49 (UTC-06:00) Central
Time (US & Canada)
4Mar-04-2021 15:28:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979754
Page 220 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Matherne Approved Mar-12-2021 12:12:16 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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-08-2021 09:28:49 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Matherne Approved Mar-04-2021 15:40:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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 Jan-26-2021 10:23:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979755
Page 221 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Paul Matherne Approved Jan-21-2021 18:13:22 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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 Jan-11-2021 11:52:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Matherne Approved Nov-05-2020 16:43:35 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979756
Page 222 of 343
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-09-2020 10:28:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020 10:28:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979757
Page 223 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020 10:28:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/9/2020Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979758
Page 224 of 343
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020 10:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11161160Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020 10:28:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020 10:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-09-2020 10:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020 10:30:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
WHITEInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979759
Page 225 of 343
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 10:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sep/9/2020Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979760
Page 226 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-09-2020 10:31:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020 10:31:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020 10:31:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
COMPLETEDInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979761
Page 227 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
205.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
73.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-09-2020 10:31:52 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979762
Page 228 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)(autocalc) 27.0
7.a
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Record Identifier
::1
Temperature: 97.6
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 10:31:52
(UTC-06:00) CentralACV0PFEINFP6000 Heather
LambertData Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979763
Page 229 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979764
Page 230 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020 10:32:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
84922Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979765
Page 231 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 10:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 10:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 18:22:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 10:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-09-2020 10:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 18:22:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sample ID: BN65G5Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979766
Page 232 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 18:22:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
BN65G5Initial Entry
5.b
Date Location User Value Reason
Sep-09-2020 18:22:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sample ID: BN65G6Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-09-2020 18:22:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
BN65G6Initial Entry
5.c
Date Location User Value Reason
Sep-09-2020 18:22:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sample ID: BLBFJ3Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-09-2020 18:22:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
BLBFJ3Initial Entry
5.d
Date Location User Value Reason
Sep-09-2020 18:22:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sample ID: BLBFJ4Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979767
Page 233 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Sep-09-2020 18:22:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
BLBFJ4Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979768
Page 234 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 10:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 10:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 18:23:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 10:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-09-2020 10:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 18:23:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sample ID: BN65PSInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979769
Page 235 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 18:23:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
BN65PSInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979770
Page 236 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
Sep/9/2020 09:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 10:33:39 ACV0PFEINFP6000 Heather Data Entry: Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979771
Page 237 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)Lambert LEFT
7. Route:
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-09-2020 10:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
YESInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979772
Page 238 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-09-2020 10:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Heather
LambertData Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979773
Page 239 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 15:22:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979774
Page 240 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020 16:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
2.a
Date Location User Value Reason
Sep-29-2020 16:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.3
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-29-2020 16:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-29-2020 16:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-29-2020 16:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979775
Page 241 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.a Temperature Location:
Date Location User Value Reason
Sep-29-2020 16:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979776
Page 242 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 15:22:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 15:22:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 15:22:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 15:22:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 15:22:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 15:22:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP4159Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979777
Page 243 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 15:22:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP4159Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979778
Page 244 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020 15:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020 16:19:18 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0979779
Page 245 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-29-2020 16:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979780
Page 246 of 343
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020 08:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 11:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-30-2020 04:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The treatment
period is defined as
1st vaccination
visit through the
1-month post
vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF
and update date of
EOT to match date
of blood sample
collection date at
visit 3.
Oct-27-2020 17:15:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979781
Page 247 of 343
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 17:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 17:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 17:18:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 17:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 17:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 17:18:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP412HInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979782
Page 248 of 343
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 17:18:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP412HInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 17:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP412GInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 17:18:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP412GInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 17:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNNRVJInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 17:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNNRVJInitial Entry
5.d
Date Location User Value Reason
Oct-27-2020 17:19:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNNRVKInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979783
Page 249 of 343
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Oct-27-2020 17:19:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNNRVKInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979784
Page 250 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021 01:25:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-26-2021 10:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered 17FEB2021
Convalescent visit
occured
Feb-17-2021 23:59:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened PDQ: Convalescent
visit is missing and
35 days (36) have
passed since
COVID Illness
Visit. If visit
occurred record
data as a matching
CONVA visit; if
visit did not occur
attempt to schedule
visit even if OOW
and obtain the
CONVA sample
else clarify.
Jan-26-2021 10:27:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-26-2021 10:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979785
Page 251 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-26-2021 10:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Jan-26-2021 10:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-26-2021 10:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979786
Page 252 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/8/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979787
Page 253 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREA
SED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979788
Page 254 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.c Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Symptom NEW OR INCREASInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979789
Page 255 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada) s: ED MUSCLE PAIN
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:YESInitial Entry
4.f Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979790
Page 256 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.g
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979791
Page 257 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.h Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Present
:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-26-2021 10:24:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979792
Page 258 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979793
Page 259 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-26-2021 10:25:37 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0979794
Page 260 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)OTHER
7. Test Result:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-26-2021 10:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NALT UNKNOWNInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0979795
Page 261 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021 10:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 10:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021 10:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-26-2021 10:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COLLECTED IN CLINICInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979796
Page 262 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-26-2021 10:27:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-26-2021 10:27:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021 10:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-26-2021 10:27:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-26-2021 10:27:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-26-2021 10:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP40XJInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979797
Page 263 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Jan-26-2021 10:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP40XJInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979798
Page 264 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979799
Page 265 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-26-2021 10:28:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979800
Page 266 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 10:28:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979801
Page 267 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:OTHER
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979802
Page 268 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COUNTY HEALTH DEPARTM
ENTInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-26-2021 10:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979803
Page 269 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. What is the treatment Identifier?
Date Location User Value Reason
Jan-26-2021 10:27:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Jan-26-2021 10:27:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Treatment:
Date Location User Value Reason
Jan-26-2021 10:27:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Treatment:
Date Location User Value Reason
Jan-26-2021 10:27:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Start Date:
Date Location User Value Reason
Jan-26-2021 10:27:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Ongoing?
Date Location User Value Reason
090177e196ae3f2e\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979804
Page 270
…[truncated]