Remote Monitoring Visit Report

Study Code: D513BC00001

Study Site Number: 7733
Principal Investigator: Prof. T Khomazyuk
Study Site Address: 53, Kalinina Ave
Dnipropetrovsk
49064
Telephone:380567605829
Fax:380567605829

VISIT SUMMARY

Visit date/s: Start Date: End Date:

Current: 17-Jan-2017 17-Jan-2017
Previous: 22-Nov-2016 22-Nov-2016
Personnel Present: Name: Role:
Study Site Personnel and
Dr K Iegorov Co/Sub Investigator
their Role:
Company Personnel and
Ms I Romanenko Monitor
their Role:
New Study Site Personnel:

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Planned number of enrolled/
10
screened subjects for site
Planned number of subjects
8
entered treatment for site

PATIENT RECRUITMENT STATUS - SUMMARY

Confirmed
Entered Enrolment 12
Dropped Enrolment 0

Entered Treatment 12
Dropped Treatment 0
Dropped Treatment, Entered Follow-up 0
Completed Treatment 0

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ISSUE/ACTION LOG

Issue Subject ID Category Issue Action Timeline Created by Status

No.
V21 Other Patients 7733003 & 7733004 had On the next IMV CRA have to Created: Ms I Romanenko Open
Monitoring to sign ICF v.3 on the Visits 10. check it. 17-Jan-2017
V22 Other IP log for subjects have not been Investigator ensured that all logs Created: Ms I Romanenko Open
Monitoring filled. filled up-to-date. 17-Jan-2017
CRA will check it on the next IMV.
V23 Other In ISF folder there had not contain Investigator was asked to send Created: Ms I Romanenko Open
Monitoring equipment certificates. it via e-mail. Investigator did not 17-Jan-2017
send it, but promised to do it.
CRA should check it's validity &
presence in ISF on the next IMV.
V18 7733004 / Other Was mentioned that ICF Master Was discussed with investigator Created: Ms I Romanenko Closed
7733004 Informed Consent Form Version Number 3 Master Version that on next planned TC with 06-Oct-2016
Date 29 September 2015, Local patient investigator should
Closed:
Version Number 3 was given to ensure / ask subjects if they
17-Jan-2017
patient for review, patient took it approved and signed current
to home, but due to the big time version 3 of ICF and remind them
distance between on-site visits the to take it to the next on-site visit.
ICFs was not returned to site by
patient. Updated on 22 of November,
2016:
Investigator confirmed that patient
is going to take mentioned ICF to
the planned on-site visit 10 and to
make signing procedure at site.

Updated on 17 of January, 2017:

Investigator confirmed that patiend
had signed mentioned ICF on Visit
10.
It will be checked by CRA on the
next IMV.

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Issue Subject ID Category Issue Action Timeline Created by Status
No.
V17 7733003 / Other Was mentioned that ICF Master Was discussed with investigator Created: Ms I Romanenko Closed
7733003 Informed Consent Form Version Number 3 Master Version that on next planned TC with 06-Oct-2016
Date 29 September 2015, Local patient investigator should
Closed:
Version Number 3 was given to ensure / ask subjects if they
17-Jan-2017
patient for review, patient took it approved and signed current
to home, but due to the big time version 3 of ICF and remind them
distance between on-site visits the to take it to the next on-site visit.
ICFs was not returned to site by
patient. Updated on 22 of November,
2016:
Investigator confirmed that patient
is going to take mentioned ICF to
the planned on-site visit 10 and to
make signing procedure at site.

Updated on 17 of January, 2017:

Investigator confirmed that patient
had signed mentioned ICF on Visit
10.
It will be checked by CRA on the
next IMV.
V9 Investigator Study File SUSARs have not been checked Investigator was asked to provide Created: Ms I Romanenko Open
SUSARs by CRA due to lack of time. SUSARs and make sure that 06-Oct-2016
it archived in ISF for it's further
review on the next IMV.

Updated on 22 of December,
2016:
Investigator was reminded that on
the next IMV will be reviewing of
SUSARs and to be sure that all
the SUSARs have been submitted
it is better to check it mothly with

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Issue Subject ID Category Issue Action Timeline Created by Status
No.
spreadsheet that CRA sends to
sites.

Updated on 17 of January, 2016:

Investigator was reminded to
provide Submission documents on
SUSARs to CRA on the next IMV.
V10 Investigator Study File Equipment certificates have not Investigator was asked to provide Created: Ms I Romanenko Closed
Missing documents been checked due to their archival certificates on the equipment 06-Oct-2016
in other folder. (ECG, centrefugue, hight meter,
Closed:
weight meter, blood pressure,
23-Jan-2017
temperature) on the next IMV. And
to archive it into the ISF.
Investigator ensured that all the
equipment is valid and up-to-date.

Updated on 22 of November,
2016:
Investigator asked to send
equipment certificates to CRA by
e-mail.

Updated on 16 of December,
2016:
Investigator sent copy of another
document. CRA informed him that
the document is not correspond to
the requested document.

Updated on 21 of December,
2016:
Certificates have not been still
provided.

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Issue Subject ID Category Issue Action Timeline Created by Status
No.
Updated on 17 of January, 2016:
Investigator was asked to provide
equipment certificates.
Investigator told that he will send it
via e-mail.

Updated on 23 of January, 2016:

There is no scan-copies of the
equipment certificates.
Issue will be closed and
certificates will be checked on the
next IMV by CRA.
V24 Investigator Study File Was detected that eTMF contains Investigator was asked to provide Created: Ms I Romanenko Open
Missing documents no new submitted documents that scan-copies of the following 17-Jan-2017
had been provided to investigator documents:
related to IB 21. EC Submission (IB 21), EC
Approval (IB 21) & IB log.

Updated on 23 of January, 2017:

Investigator sent EC Approval on
IB 21.

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VISIT DETAILS

1. Activity addressed during the contact Yes No N/A

x
a) Performed training:

Comment: Were discussed end-point events & it's reporting.

x
b) Discussed recruitment:

x
c) Discussed Subjects eligibility:

x
d) Discussed critical study data:

Comment: No critical study data.

x
e) Discussed Informed Consent issues

Comment: Investigator conirmed that subjects 7733003 & 7733004 signed ICF v.3 at Visit 10.
For more information, please, check issue / action log: V17, 18, 21.
x
f) Discussed Serious Adverse Event or endpoint  issues

Comment: No Serious Adverse Event or endpoint issues.

x
g) Discussed study site facility and/or staff changes

Comment: Investigator was asked to send equipment certificates.

For more information, please, check issue / action log: V10, 23.
x
h) Discussed issues identified during eCRF, WBDC or other  study-
specific system review i.e IWRS etc

Comment: No issues identified during eCRF, WBDC or other study-specific system review
i.e IWRS etc.
Average time to data entry is 2,4 days.
x
i) Resolved data queries

Comment: Data queries resolved on ongoing basis.

x
j) Discussed study drug and/or study supply issues

Comment: Was reminded that IP logs will be checked on the next IMV.

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For more information, please, check issue / action log: V22.
x
k) Discussed biological sampling handling issues

Comment: No biological sampling handling issues.

x
l) Discussed ISF and source documents

Comment: Investigator was asked to provide EC Submission (IB 21), EC Approval (IB 21) &
IB log.
For more information, please, check issue / action log: V24.
x
m) Discussed any quality or protocol-related issues 

Comment: Was reminded to be sure that all the SUSARs have been submitted it is better to
check it mothly with spreadsheet that CRA sends to sites, because on the next IMV CRA will
check SUSARs.
For more information, please, check issue / action log: V9.
x
n) Reviewed outstanding action items from the most recent monitoring
visit 

Comment: Was discussed the spreadsheet of Medical Importaint Events that had been sent
by CRA via e-mail.
x
o) Discussed the importance of all retention aspects, withdrawal of
consent and potential lost to follow-up subjects

Comment: Was reminded about the importance of all retention aspects, withdrawal of consent
and potential lost to follow-up subjects .
x
p) Discussed any items that may be expiring soon (i.e. IRB approvals,
medical licences, export permits, GCP training etc)

Comment: No items that may be expiring soon.

q) Discussed any current milestones eg interim analysis, database lock
timelines etc

Comment: Was discussed timelines for data entry, transmittal form submission, visit
timeframes for patients.
x
r) Other, specify

x
s) Discussed that site will be notified in writing of any actions arising
from this contact

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ADDITIONAL COMMENTS

Date report created: 24-Jan-17

Date

Prepared by: Ms I Romanenko 24-Jan-17

Monitor Date

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