Protocol Deviation or Violation Report – Version Date (01/03/2017)

(Only for MREC approved sites in Malaysia)

1. The
Corresponding
Person, Backup
Corresponding
Person,
Investigator,
SAEs/SUSARs/PD
Coordinator,
SAEs/SUSARs/PD
Correspondence
Person must log
in to NMRR first.

2.  CP, CP Backup & Principal / Coordinating Investigator are allowed to submit PD

for all sites.
 Site Investigator only allow access and submit PD for their own sites.
 SAEs/SUSARs/PD Coordinator, SAEs/SUSARs/PD Correspondence Person only
allow access and submit PD for their own sites.
 Sponsor & CRO can view PD for all sites but NOT allow to Submit.

1) Email will be sent to:

a. Principal / Coordinating Investigator (PI)
b. Reporting Investigator
c. SAEs/SUSARs/PD Correspondence Person
d. Person who created or submitted the PD Report

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3. At the User /
Researcher Main
Menu, click at “5.
Protocol
Deviation or
Violation Report
(Only for MREC
approved sites in
Malaysia)”

4. Search for the

Research.

Click on “PD”

5. Click “Add new

Protocol
Deviation/
Violation Report”
to register new
PD Report.

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6. Fill in PD form
and click “Save”

7. Download the
prefilled Cover
Letter.

Print out the

Note : Please Save before download the prefilled template cover letter and
sign it and upload
back to the
system.

Click “Save” to
next step.
8. If all the required
information had
been filled, click
“Submit Report”
to continue.
9. A pdf of PD
Report will
generated. Click
the pdf icon to
view and tick
checkbox for
verifying. Click
“Confirm submit
report to MREC”
to finish.

After submit, PD

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 report is not
editable
anymore.

An
acknowledgemen
t email will be
sent to the
following:
User who
submitted /
Created the
report, Reporting
Investigator, PI &
SAEs/SUSARs/PD
Correspondence
Person.
10. Follow Up

In some cases,
Secretariat may
request to submit
follow up.

Click the image to

Update / Submit
Follow Up.

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11. Click ‘Save Follow
Up’ button to
save.

Click ‘Submit
Follow Up’ button
to Submit Follow
Up.