PENYELIDIKAN

KESIHATAN PERSEKITARAN
DI KALANGAN PPKP/PKP

ZULKARNAIN BIN RAMLI

PEGAWAI KESIHATAN KESIHATAN U42
INSTITUT KESIHATAN UMUM
0129282012 / zulkarnain.ramli@moh.gov.my
PERSEDIAAN

 Make sure:
 Study Title
 Study Background: Problem statement, Study Justification, Implication
 Study objective(s) ~ must be measurable (Hints: Study findings)
 Methodology kecuali sampling calculation
 Data cleaned
 Identify study variables (dependent and independent)
 Data dictionary
WHAT’S NEXT?

1. Register yourself as a user (researcher) in NMRR system – What is NMRR?

2. Descriptive data analysis –
1. Kenalpasti Data
2. Make sure variables yang nak digunakan semua ada/ telah key in jika ada yang perlu extract dari borang penyiasatan
3. Make sure data telah clean
4. Akan jalankan analisa secara hands on bagi analisa diskriptif.

3. Selepas perkara di atas telah selesai analisa diskriptif data, termasuk Table 1.
4. Analisa spatial jika perlu
 RESEARCH
REGISTRATIO
N IN NMRR
18 SEPTEMBER 2023 (ISNIN)

ZULKARNAIN BIN RAMLI

PEGAWAI KESIHATAN PERSEKITARAN U42
INSTITUT KESIHATAN UMUM
 PRESENTATION COVER :-

Introduction & Overview of NMRR

Application & Submission to NMRR

Research Registration Steps in NMRR

NATIONAL MEDICAL RESEARCH REGISTER (NMRR) VERSION 2.0 – NMRR.GOV.MY
WHAT IS NMRR

 NMRR – National Medical Research Register

 A web based tool to support NIH guidelines regarding research

 National Institutes of Health NIH guidelines 2007 SEHINGGA
 3rd Edition, 2021- This updated guideline is officially in use with the
release of the Director General of Health Malaysia Circular No 4/ 2022
released on 31st January 2022
 WHEN TO APPLY NMRR
Criteria to Apply/Register Research with NMRR:-
(any one of the following)
1. Plan to conduct research involving Ministry of Health
2. Submission to Medical Research & Ethic Committee (MREC),
MOH for ethical review & approval
3. Plan to conduct research using MOH Medical Research Grant
(MRG)
4. Publication or Presentation Approval for study results involving
Ministry of Health
5. All clinical trial conducted in Malaysia : following the requirement of
CTIL, CTX by National Pharmaceutical Regulatory Agency(NPRA)
 Involving
Using MOH MOH as
facilities Study
Team

All
Clinical
Using Investigate Study involving
or with no
Trial in
MOH affiliated Ministry of
Malaysia
Patients Health and is
required to
Using Involving
MOH as register in NMRR
MOH
Study
Data Subject
 MOH
Using MOH personnel
samples/ as Principal
specimens investigator
(PI) Study requires
to obtain ethical
Using Investigator
MOH with no approval from
affiliated
Patients MREC,MOH prior
to commencing
Using Involving
data collection/
MOH MOH as recruitment
Data Study
(secondary data) Subject
 RESEARCH REVIEW & ETHICAL APPROVAL
Ethic approval must be obtained prior to research
initiation
Types of Research Requiring Ethical Types of Research Not Requiring
Approval Ethical Approval * (MREC Exemption)
• Involving human subject • Clinical Audit**
interaction • Case Report / Series
• Secondary data and • Quality Assurance/ Quality Control
Identifiable information (Doesn’t involve any intervention)
• Systematic Review/Scoping
• Interventional study
Review/Meta Analysis
• Clinical trial • Publicly available data
* all study must be registered with NMRR
** Clinical audit :a systematic analysis of the quality of medical care such as the diagnostic procedure in place and/or the treatment, the use
of resources, and the resulting outcome. It involves comparing intervention(s) / service(s) in use and measures against a standard
clinical care / practice / guideline. Usually involves analysis of existing data but may also include administration of simple interview or
questionnaire. There is no allocation to any intervention on patients/subjects & no analysis of relationship conducted . MREC would require
institutional authorisation in order for it to be exempted from MREC review. (the same with public health surveillance activities)
How to Apply/Register Study in
NMRR
• Log in into nmrr.gov.my
• One representative from the study team is
needed ( act as Corresponding Person) for
registration submission
• All study team investigator must have an
account with NMRR
 Overview of Registration & Approval Flow Process of
Research in MOH
Kebanyakan Research
kajian kita Registered in
NMRR (without
MRG
akan melalui the scientific Secretariat
proses ini
review & ethical (study
approval
with MRG
sahaja requirement)
Application
JPP NIH )
Secretariat
Grant
application
Research
Registration NMRR Investigator
without/ with other Secretariat MREC starts the study
recruitment /data
purpose of (Registration) Secretariat collection with
submission With ethical the site approval
approval (if applicable)

Scientific Review JPP CRC HRRC

Secretariat Secretariat
Ethical Review &
Approval
 Registration
As A NMRR User
Fill the Detail

Create Account
 GET
UPDATE !!!
Registration – Scientific &
Ethical Review Processing
Flowchart
Through Online
NEXT MEET UP
Research Registration Steps
in NMRR v2.0
Function Enable in current NMRR v2
• Submission for New Research Registration
• Editing & Comment Response during “Revision
Required/Incomplete Submission”
• Deletion of Submission (only for submission without NMRR ID
and in the pending submission or incomplete submission stage)
Basic Investigator/CRA
Function & Menu
Basic Investigator/CRA
Menu

Shortcut Menu

Directories Menu

Support Menu
 Landing Page
Email
(Investigator/CRA Notifications
Dashboard)

Name
Profile Access/
Change
Password
 Landing Page
(Investigator/CRA
Dashboard)
Name

Pending Registered Submission

Completed Study –
Submission/Incomplete Submission Undergoing & Submission with
Function Not Yet
Submission/Revision Review Decision by MREC
Available
Required (Approved & Exempted)
 My Submission:
• For Research/Submission that is created by the
user– able to be edited
• Principal Investigator/Main Corresponding Person
(CP) and Backup CP will also has the access from
“My Submission”

3 button
accessible
View (eye)
Edit (pencil)
Delete
(bin)
 My Research :
• For Research/Submission that investigator is part of
the study team.
• User will only be able to view the submission (click
the ‘eye’ icon) expect for Principal Investigator
where the submission is editable
 New Research Submission
Steps

**For further explanation with regard to the term and parameter

available in NMRR, please download “NMRR Research
Registration Data Elements & Documents for Submission”
available in NMRR > Document >User Manual
 ①

②
New Submission Registration
③

• Insert information on the “New

Submission Registration”. Basic
information required are as
follows;
 Submission type
 Research title
 Public title
 Research title abbreviation
 Protocol ID
 Research Scope
 ④

 Once basic general information is inserted, select one Research Type. it can be
either:
 Interventional
 Observational Kebanyakan team
 Qualitative Research
 Mixed Method Research
 Proof of Concept/Theoretical Research
 Applied Research
 Registry/Biobanking/Clinical Database
 Clinical Audit/Quality Assurance/Quality Control
 Systematic Review/Scoping Review/Rapid Review/Meta-Analysis/ Meta-
synthesis
 Special Write-Up
 Then Click Create New Submission
 Interventional Research Types
 Bioavailability/ Bioequivalent Study
 Clinical Trial (MGCP definition)
 Interventional Study (Other than clinical trial)
 Quasi Experimental/ Pilot Project/ Feasibility Study
 Observational
 Case Study/Case Series
 Cross Sectional
 Cohort
 Case Control Kebanyakan team PPKP/PKP
 Case Cross-Over
 Ecological/Community
 Family Based
 Others
 Research Types
 Qualitative
 Mixed Method (Both Observational & Qualitative)
 Proof of Concept/Theoretical Research
 Applied Research (Biology, Cell-Based, Animal Study, Genetic, Physiology
and etc2)
 Registry/Biobanking/Clinical Database
 Clinical Audit/ Quality Assurance/Quality Control
 Systematic Review/ Scoping Review/Rapid review/Meta Analysis/Meta-
Synthesis
 Special Write Up
 Article
 Journal Review
 Book/Chapter
 Technical Report
 ④

③
 Click Updates in General Information
section if only there is addition
changes in the General Information
⑤
Section ④
 Continue by inserting the information
⑥ on other Section
 Study Information
 Study Site
⑦  Investigator & Sponsor
 Different Research Type will require
⑧
different study information to be
filled up
 Study Information Required Based on Specific
Research Type (Dropdown ,Choose &
Interventional
Describe) Qualitative
Observational Mixed-Method
 Subtype Qualitative Design
 Study Model &  Observational
 Secondary ID Approach
Description • Phenomenologi
 Study Phase  Qualitative
 Sampling Method cal
 Interventional • Simple Random • Narrative Registry/Biobanking/
Allocation • Systematic • Case Study Clinical Database
 Study Random • Historical
Assignment • Purposive • Ethnography Biospecimen
 Study Arm • Convenience • Grounded Collection/Archiving
 Masking/ • Others Theory Individual
Blinding  Time Perspective  Qualitative Participant Data
 Study • Prospective Method (IPD) Sharing
Purpose • Retrospective • In-depth
 Investigation • Cross sectional (at interview
• Focus group
al Product one particular time
• Other discussion
 Biospecimen • Participant
Collection/Archiving observation
 Interventional Study Information

Interventional  Study
• Single Group
Study Purpose Biospecimen
 Subtype Assignment Treatment Collection/Archiving
• Parallel Group
• Prevention • Status (Not
 Secondary ID • Cross-Over Group
Retained, Retained
• Available • Factorial • Diagnostic for Future Use,
• Unavailable • Sequential Not Applicable)
• Supportive
 Study Arm (Describe • With/ without DNA
 Study Phase Care
• the type of arm) • Expected total no of
Phase 1 • Experimental • Screening biospecimen
• Phase 1 / 2 • • Health
Active Comparator collected & archiving
• Phase 2 • Placebo Comparator • Expected collection
• Services
Phase 2/Phase 3 • Sham Comparator per subject
• Research
Phase 4 • No intervention
• N/A • Basic Individual
 Masking/Blinding Participant Data
Interventional • Science
Open Label (IPD) Sharing
Allocation • Single Blinded • Device
• RCT • Double Blinded Feasibility
• Non RCT • Triple Blinded • Others (to
• N/A • Others (to specify) specify)
Investigational
Tips!
• Information like
objective, inclusion &
exclusion criteria need to
be listed individually per
point. Click “add” to insert
another point if
information. Then click
save
Tips!

For outcome measure:

• Type : Primary or secondary
• Name: Description of the
outcome
• Measurement/method: tool for
the outcome measurement (e.g.:
questionnaire, complex
analysis
– chi square, t-test, intention
to treat, per protocol analysis
and etc2), Blood investigation,
interview, data collection form
and others )
• Time point measurement :
timeframe where the outcome
is measured (e.g.: week 2, day
7 of illness, end of data
collection and others)
Tips!
• To select the ethical
application Submission
status as “Required” if the
study is considered type of
research that requires ethical
approval or if investigator
would like to have the
“exemption letter” from
MREC
 Study Site Information

The is used when the name of study site is not

listed in the database. Kindly call/email NMRR
secretariat for assistance

• Click Add , enter the name of the establishment inside the search box, list
of relevant establishments will appear . Select the study site by clicking on
the name of the establishment
 Investigator & Sponsor Section
• Study Team Listing ( Principal Investigator, Principal Investigators at
site, Sub Investigator, Expert Opinion)
• IAHODIA form is compulsory to be uploaded by PI & PI at site.
CV is compulsory for all study team to be uploaded ( if CV is
present in investigator profile, it will be auto-displayed in the study
team section)
• Corresponding Person Listing ( Principal Investigator ,
Main Corresponding Person, Backup Corresponding
Person)
• Sponsor Information Listing ( Type of Sponsorship, Sponsor
Establishment, Sponsor Contact Detail)
⑦
  Investigator with CV & GCP
certs already uploaded into
individual
profile will have the documents
displayed when the name is
selected
 Investigator can upload the CV of
other study team investigators
but the documents can’t be
Click to download the prefilled downloaded
IAHODIA form

Tips!
Always update your CV into the
latest information especially
on the current establishment /
workplace
 Select the Purpose of Submission
& Save

 Investigator can also notify other

IRB/IEC and relevant authority
  Upload the documents required for the
⑨ rest of the section. Different Research
Type requires different type of
documents to be uploaded.
 Costing detail is required to be
⑩ inserted at section ⑩
SUBMISSION