MOH/S/CRC/66.

21(GU)-e

GUIDELINES
ON CONDUCTING CLINICAL
RESEARCH IN
HOSPITAL KUALA LUMPUR

First Edition 2021

Clinical Research Centre

Hospital Kuala Lumpur
(CRC HKL)
DISCLAIMER:
This document serves as a guideline for researchers intending to conduct research in Hospital
Kuala Lumpur and is only applicable in Hospital Kuala Lumpur. Other study sites may
implement different procedures and requirements.

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FOREWORD

Hospital Kuala Lumpur (HKL) acts as the main hub in conducting clinical research in Malaysia.
It has twenty-six clinical and fifteen support departments which houses tremendous patients’
data pool. Since several years ago, the number of studies conducted in Hospital Kuala Lumpur
have shown a substantial increment trend and up to today there are hundreds of Industry
Sponsored Research (ISR) and thousands of Investigator Initiated Research (IIR) have been
conducted.

The establishment of Clinical Research Centre Hospital Kuala Lumpur (CRC HKL) in 2012 is
vital to ensure continuous support for all research activities and operations. We are
responsible to ensure all research carried out in Hospital Kuala Lumpur have been approved
by an ethical board and have obtained the site approval consent prior to commencement.

This guideline can be used as a reference on conducting research in Hospital Kuala Lumpur,
mainly in facilitating the processes of getting the study site approval as well as the ethical
approval. These approvals are crucial to produce high quality studies, to ensure patients’
safety and rights are protected in accordance to Malaysian Good Clinical Practice.

I would like to thank the committee members for their incredulous effort in preparing this
first edition of guidelines on conducting research in Hospital Kuala Lumpur 2021. With this
guideline, I hope all investigators especially HKL staff who are planning to embark on clinical
research would be aware of all the necessary processes and requirements in order to
conduct research that is compliant towards the standard regulation sets up by the Ministry of
Health.

Thank You.

Dr Hjh. Salina Abdul Aziz

Head of Unit
Clinical Research Centre
Hospital Kuala Lumpur

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 COMMITTEE BOARD OF GUIDELINES ON CONDUCTING CLINICAL RESEARCH IN
HOSPITAL KUALA LUMPUR

ADVISOR

DR. HJH SALINA ABDUL AZIZ

Head of Psychiatric & Mental Health Department and Clinical Research Centre
Hospital Kuala Lumpur

COMMITTEE

DR. KARINA KOH

Deputy Head Clinical Research Centre
Hospital Kuala Lumpur

DR. MOHD AZIZUDDIN AMIR SHARIFFUDDIN

Secretariat of Hospital Research Review Committee
Hospital Kuala Lumpur

DR. NIK NUR ELIZA MOHAMED

Coordinator of Promotion and Collaboration Clinical Research Centre
Hospital Kuala Lumpur

DR. LEE JEN VEN

Coordinator of Research Operation Clinical Research Centre
Hospital Kuala Lumpur

DR. NOOR HIDAYU WAHAB

Coordinator of Research Quality Clinical Research Centre
Hospital Kuala Lumpur

DR. NOR ALIYA AYUB

Coordinator of Research Quality Clinical Research Centre
Hospital Kuala Lumpur

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CONTENTS

Abbreviation List 6
Section 1: Research Registration in National Medical Research Register (NMRR)
1.1 NMRR 7
1.2 Importance of Registering Research in NMRR 7
1.3 Personnel to Register in NMRR 8
Section 2: Medical Research and Ethics Committee (MREC)
2.1 MREC Review and Approval 9
2.2 Type of Research Require MREC Ethical Approval 9
2.3 Type of Research Does Not Require Ethical Approval 10
2.4 Information Sheet and Informed Consent 10
Section 3: Site Approval
3.1 Research Registration in Clinical Research Centre (CRC) HKL 12
3.2 Letter of Agreement (LoA) 14
3.3 Clinical Trial Agreement (CTA) 14
3.4 Temporary Pass 15
Section 4: Research Using Secondary Data
4.1 Patients Medical Record 16
4.2 Department’s Clinical Database or Registry 16
Section 5: Study Update
5.1 Study Renewal 17
5.2 Study Closure / Termination 17
Section 6: Director General’s (DG’s) Approval for Publication and Presentation
6.1 DG’s Approval Application 18
6.2 Document Requirement for DG’s Approval Application 18
STEP BY STEP Prior Conducting Research in Hospital Kuala Lumpur 19
Applications Purpose and Related Documents Requirement 21
Appendices List 22
Appendix 1 23
Appendix 2 25
Appendix 3 26
Appendix 4 27
Appendix 5 31
Appendix 6 32
Appendix 7 36
Appendix 8 38
References 40

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ABBREVIATION LIST

1 CRC HKL Clinical Research Centre Hospital Kuala Lumpur

2 CRM Clinical Research Malaysia

3 CTA Clinical Trial Agreement

4 CV Curriculum Vitae

5 DG’s Approval Director General of Health Malaysia Approval

6 HKL Hospital Kuala Lumpur

7 IA-HOD-IA Investigator's Agreement-Head of Department-

Institutional Approval
8 IIR Investigator Initiated Research

9 ISR Industry Sponsored Research

10 JPP-NIH Jawatankuasa Penilaian Penyelidikan National Institute

of Health

11 LoA Letter of Agreement

12 MoA Memorandum of Agreement

13 MoH Ministry of Health Malaysia

14 MREC Medical Research and Ethics Committee

15 NIH National Institute of Health Malaysia

16 NMRR National Medical Research Register

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Section 1: Research Registration in National Medical Research Register (NMRR)

1.1 NMRR

NMRR is a web-based platform designed to support the implementation of the National

Institute of Health (NIH) guidelines on the conduct of research in the Ministry of Health
Malaysia (MoH) institutes and facilities. It was designed and established in 2007. This
development corresponds with the international guidelines requiring medical research
(particularly clinical research) to be registered in a publicly accessible registry. NMRR
provides a one-stop centre for the researchers to assist them for the online research
registration and submission to appropriate authority for approval, review and subsequent
publication. Services available under this integrated system include the following:1

i. Research Registration Application

ii. Links for Review of Research Protocol by the Respective Authorities
iii. Links to Ethical Approval
iv. Links for Medical Research Grant application
v. Links for Director General Approval Application for Presentation and Publication.

Visit NMRR at www.nmrr.gov.my for more information.

1.2 The Importance of Registering Research in NMRR

The importance of registering research in NMRR as follow:1

- It links to ethics approval and MoH medical research grant application. Thus,
facilitates researchers in their application to the Ministry of Health Research and
Ethics Committee (MREC) and for Ministry of Health Research Grant.
- Reduce review time and enable investigators to track the status of their research
online
- Enable MoH management to document the level of research activity in its facilities
and to track the progress of the research that it has approved and/or supported.
- Increase public trusts and confidence in the research conduct that require volunteer
participation from public as some basic information such as name of investigator,
name of their institution and study title may be viewed by the public from the
website.

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1.3 Personnel to Register in NMRR

1.3.1 Based on NIH guideline and Director General Circular No. 10 /2015 (Surat Pekeliling
Ketua Pengarah Kesihatan Malaysia), all types of research conducted in MoH facilities either
by MoH staff or non-MoH staff, using data or patients from MoH facilities warrant a
registration in NMRR.2

Refer Appendix 1 for Director General Circular No. 10 /2015.

1.3.2 Investigators must register their research in NMRR and submission to respective
authorities before engaging in any research activities that involve human subjects or
involving clinical data investigation.

1.3.3 Any research conducted by MoH staff in MoH facilities or other facilities, or any
research by non MoH staff in MoH facilities is required to be registered in NMRR. Ethical
approval is required depending on the type of the research involved.

1.3.4 For any particular research, only one-off registration is required. Unique NMRR
registration ID will be assigned for each research. All the researchers involved in a particular
research are not required to register the research separately. However, all investigators
involved in the research are required to have a registered account in NMRR to be listed as an
investigator.

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Section 2: Medical Research Ethics Committee (MREC)

2.1 MREC Review and Approval

2.1.1 Medical Research and Ethics Committee (MREC) is a committee established under the
authority of the Director-General of Health Malaysia to review and to approve research
involving human subjects, conducted by MoH investigators and/or in MoH facilities or
research to be funded by a MoH research grant.2,3

2.1.2 MREC approval is essential to ensure the protection of the rights, safety and well-being
of potential participants as well as those participants involved in a trial/research.

2.1.3 MREC reviews are categorised as full board review, expedited review and exempted
review and no research can commence until the investigator has written and dated approval
from the MREC. It is the responsibility of Correspondence Person to acquire ethical approval
or to obtain exemption of ethical review from MREC before embarking on the conduct of
clinical research.

2.1.4 Research protocol that has been uploaded onto the NMRR website will be forwarded to
the respective authorities (such as Hospital Research Review Committee in CRC Hospital) for
review and rating recommendation for MREC approval.

2.1.5 You may refer to Appendix 2 for process flow of Non-NIH Investigator/Researcher, not
requesting for grant using MoH facilities, data and/or MoH patients and refer Appendix 3 for
process flow of Non-NIH Researcher/Investigator applying for MoH research grant.

2.2 Type of Research Require MREC Ethical Approval.

2.2.1 All research involving human subjects requires ethics review and approval by the
Medical Research and Ethics Committee (MREC). A human subject (in the context of
research) is a living individual about whom an investigator obtains either:5
- data through intervention (e.g., clinical trial)
- observational study involving interaction with the individual (e.g., physical
examination, questionnaires, interviews)
- data through secondary source such as clinical or disease registry or database,
existing medical or laboratory record

2.2.2 Research involving human remains, cadavers, tissues, biological fluids, embryos or
foetuses. For biological tissue/specimens which have been collected during routine
investigation or treatment and have been stored in the biobank for the future use in
research, the ethical approvals are still required before conducting the research using such
bio materials. Please refer to the Malaysian Guidelines on The Use of Human Biological
Samples for Research for further information.4

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2.2.3 Research about health system involving administration data, accounting data and
human resource in any MoH facilities require MREC approval.

2.3 Type of Research which Does Not Require Ethical Approval.

2.3.1 Research based on review of published/publicly reported literature. Example,

systematic review.

2.3.2 Research not involving human subject, may be exempted from MoH MREC review and
approval. However, this type of research might need to have ethical review from other
relevant or respective authorities that related with investigator’s institution.

2.3.3 Case Report and Case Series do not require ethical approval. Case series is defined as a
group of case reports which reporting less than 10 patients.

2.3.4 For Case report, Case Series and Systematic Review, the investigators have to register
their research in NMRR to get the NMRR ID.
• This NMRR ID is unique for each research registration; however, it does not represent
the ethical approval. This NMRR ID is important if investigator plan for publication or
presentation as it is required for DG’s Approval application process later.

2.4 Information Sheet and Informed Consent

2.4.1 Information Sheet

Prior to making decision on the research participation, the potential research

participants require appropriate and adequate information regarding the research. Hence, it
is imperative that fully disclosed relevant information which must be clear, concise and
comprehensible to the participants are given to them before obtaining their written informed
consent.

Depending on your research objective, you may need to consider a number of information
sheets as follows:

• participant information sheet for adults

• information sheet for parents/guardians (if involving children/young people)
• information sheet(s) for children/young people

Information sheets should be designed for each appropriate age range to reflect
comprehension and development, for example:

- Children or young people 11–15 years

- Children 6–10 years

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 - Children 5 years and under: predominantly pictorial, with very simple sentences to be
shown/read to the child. Parents need to provide parental consent since assent is not
sought from children under the age of 5.

2.4.2 Informed Consent Form

The informed consent form is to be designed so that the participant is consenting to

everything described in the text of the information sheet. The purpose of the form is to
record the participant’s decision to take part.

For some studies, specific text may be needed to cover important issues, especially if
additional elements are optional for the participant. These may include:

• additional invasive tests or samples required for study purposes only, not routine
practice
• consent to use of audio/video-taping, or use of photographs
• requirement to contact their personal doctor if required

For consent to use the remaining blood/tissue samples for future research, investigators are
required to provide separate informed consent form.

For research involving minor subjects’ participants (age less than 18 years old), you have to
prepare assent form to get proxy consent from parents/guardians.

Informed Consent required Informed Consent not required

▪ Research involving direct interaction with
human subject.
▪ Example interview, questionnaire,
physical examination and clinical trial.
▪ Research using secondary data only such
as clinical/disease registry, clinical
database, laboratories and medical
records, without any kind of interaction
with human throughout the research
activities.

You may use the templates of patient information sheet and informed consent which are
available in NMRR Website under the section “user manual/ document”.6

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Section 3: Study Site Approval

3.1 Research Registration in CRC HKL

3.1.1 Research conducted in Hospital Kuala Lumpur requires permission or approval from the
Head of Department(s) of the data collection site and subsequently the approval from
Hospital Kuala Lumpur Director. The need of site approval is to ensure the data integrity, to
prevent data breach and data leak especially among non-HKL investigators conducting clinical
research in Hospital Kuala Lumpur.

3.1.2 In order to get the site approval, it is compulsory for investigators to register their
research with CRC HKL. CRC HKL will then provide 2 forms; AK-02-01 and AK-02-02 to be
signed by investigator(s), Head of Department(s) and Hospital Kuala Lumpur Director. These
two forms are unique to HKL and are used to substitute the Appendix 5 of MREC approval.

Refer Appendix 4, example of AK-02-01 and AK-02-02

3.1.3 To register with CRC HKL, investigators whom are HKL staff required to bring IA-HOD-IA
form and their research proposal. However, for non-HKL staff, MREC approval is mandatory
upon research registration with CRC HKL. Registration with CRC HKL can be done via walk-in
to CRC HKL office or via online (email to crc.hkl@moh.gov.my )

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3.1.4 Research to be conducted by undergraduate, postgraduate, nursing or allied health
training programs students are considered as research by the non-HKL staff. For any research
with the non-HKL staff as the Principal Investigator, it is obligatory to include at least one (1)
investigator / supervisor / coordinator from HKL to join the research team.

3.1.5 Prior to conduct any clinical research in Hospital Kuala Lumpur, the Principal
Investigator is strongly advised to discuss the proposed research with the research
coordinator / person in-charged at the department of the data collection site.

3.2 Letter of Agreement

3.2.1 For Investigator Initiated Research (IIR), Letter of Agreement (LoA) is obligatory for
research between MoH institutions / divisions personnel and in collaboration with
investigator from non-MoH institution including any private association, private university
and sponsoring organisation. The sponsorship may include financial, medications, reagents,
laboratory test, equipment and devices. LoA should be signed by the legal representative of
the non-MoH institution and HKL Director.

3.2.2 Any research to be conducted by undergraduate, postgraduate, nursing or allied health

training programs students from seven (7) Public University that listed in CRC registration
flow chart does not require LoA. They are covered by Memorandum of Agreement (MoA)
between MoH and these designated universities.

Refer Template for Letter of Agreement from Institute of Clinical Research (ICR).7

3.3 Clinical Trial Agreement

3.3.1 A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the
relationship between the sponsor that may be providing the study drug or device, the
financial support and /or proprietary information and the institution that may be providing
data and/or results, publication, input into further intellectual property

3.3.2 CTA is an important document for Industrial Sponsor Research. CTA includes all the
allocation of risk, responsibility, funds, obligations, and the protection of academic, legal,
intellectual property and integrity.

3.3.3 A CTA should describe and acknowledge responsibilities, terms of collaboration,

requirements for payment and reimbursement, publication and intellectual property terms,
indemnification and or insurance, subject injury coverage, guidelines for dispute resolution,
grounds for termination of contract, and possibility of amending contract terms in the
future.8

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3.3.4 CTA is required upon registration of any ISR study with CRC HKL. For any ISR study, it is
compulsory to engage with Clinical Research Malaysia (CRM) prior to any clinical research
being conducted in any Ministry of Health facilities.

3.4 Temporary Pass

3.4.1 Temporary Pass is required for all non-HKL investigators who are planning to conduct
research in HKL. To apply for a temporary pass, investigators need to complete the
Temporary Pass Application Form which will be given after completing the research
registration with CRC HKL (after the submission of AK 02-01 & AK 02-02 forms).

3.4.2 This form will be signed by head of CRC HKL and need to be submitted to Cawangan
Keselamatan Hospital Kuala Lumpur together with two (2) passport size photos.

3.4.3 Any research activities in HKL by non-HKL staff can only be done after getting the
temporary pass. Any short-term Research Assistant hired in any research conducted in HKL is
required to apply for the temporary pass.

Refer Appendix 5 for Temporary Pass Application Form

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Section 4: Research Using Secondary Data

Research utilising the secondary data is a type of research which involves existing data. It
means that the data has already been collected through primary sources and made available
for the researchers to use for their own research. Secondary data includes medical records of
patients, clinical database and published journals. The usage of secondary data needs the
respective department’s approval prior to the data collection or extraction.

4.1 Patients Medical Record

4.1.1 In Hospital Kuala Lumpur, patients’ medical records are stored in Medical Records
Department. Investigators who require access to patients’ records must obtain the approval
from the Head of Medical Records Departments prior to the data collection. An official
application for the approval must be sought by sending a formal letter to the Medical
Records Department, along with a copy of AK-02-01, AK-02-02 and MREC Approval Letter to
request access to the data.

4.2 Department’s Clinical Database or Registry

4.2.1 For clinical database constituted by certain departments, the approval from respective
head of department is mandatory. For this purpose, it is adequate for the respective head of
department to sign the AK-02-02 with the subsequent signature by the HKL Director.
Investigator from another department is recommended to have at least one (1) investigator
from the database owner department.

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Section 5: Study Update

Study status / update should be informed to CRC HKL. It can be done by contacting CRC HKL
via email or in person to notify the latest status of their research. Alternatively, the
researchers could contact the respective research coordinators in the department of their
research site. CRC HKL will periodically request data on research updates from all
departments via the respective research coordinator.

5.1 Study Renewal

5.1.1 MREC approval is valid for one (1) year from the date of approval for every study. If the
study is still ongoing, investigator should submit Continuing Review Form and request for
study renewal via NMRR to MREC within 2 months (60 days) prior to the expiry of ethical
approval. Once the researchers have received the study renewal approval letter from the
MREC, investigators should update and send a copy of the approval letter to CRC HKL. Refer
NMRR website user manual for Study Renewal Guide. 8

5.2 Study Closure/ Termination

5.2.1 A study closure form should be submitted to the MREC after completing the research /
study, while study termination should be requested if investigator is planning to terminate
their study. Both options can be performed on the NMRR website.

5.2.2 Study Final Report is applicable when study has been completed at all MREC approved
sites and must be submitted via NMRR within two (2) months from study completion.

5.2.3 Study Termination Memorandum is applicable when study has been terminated at all
MREC approved sites and must be submitted via NMRR within one (1) month from study
termination.

5.2.4 Study Final Report, Study Termination Memorandum template and study closure guide
can be downloaded from NMRR website under the section ‘user manuals/ documents’.9

5.2.5 Study closure / Termination should also be updated to CRC HKL and it is recommended
to send a softcopy of published manuscript/ study final report to CRCHKL.

Refer Appendix 6 for Study Final Report and Study Termination Memorandum

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Section 6: Director General’s (DG’s) Approval for Publication and Presentation

6.1 DG’s Approval application

6.1.1 For dissemination of research outputs through oral or poster presentation and
publication, investigator is required to apply for Director General Approval prior to
publication in any journal or presentation at any conference. This is in line with NIH
Guidelines for Conducting Research in Ministry of Health Institutions and Facilities, as well as
in Director General Circular Bil. 10/2015.

6.1.2 All dissemination of research outputs such as abstracts for oral and poster presentation,
research reports, journal articles or conference proceedings, arising from research
undertaken by Ministry of Health (MoH) personnel OR conducted at MoH facilities OR funded
by an MoH research grant, shall require prior review by the NIH, and subsequent approval by
the Director General of Health.

6.1.3 Application for DG’s Approval can be done via NMRR website or directly email the
required document together with P1 (publication) and P2 (presentation) forms to
nihpub@moh.gov.my. Refer Appendix 7 for PI and P2 form

6.1.4 Upon receiving the approval, the investigator may use it for multiple submissions in
different journals or different conferences. However, should there be any major changes in
the manuscript after received the Director General approval; the investigator should apply
for a new Director General approval for publication/presentation.

Refer Appendix 8 for cover letter of publication and presentation application.

6.2 Document requirement for DG’s Approval application

6.2.1 Documents required for publication

- Cover Letter for Director General
- Manuscript
- Form P1
6.2.2 Documents required for Presentation
- Cover Letter for Director General
- Abstract
- Form P2

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STEP BY STEP
Prior Conducting Research in Hospital Kuala Lumpur

1. Visit NMRR at www.nmrr.gov.my

2. Create a new account, (if no prior account had been registered) then sign in using new
account- user log in
3. USER/RESEARCHER tab
a. Register new research protocol -> choose Investigator Initiated Research (IIR) or
Industry Sponsored Research (ISR) if a drug company sponsored research OR
b. Update submission to existing protocol
4. Fill up Section 1-6
a. Section 1.4.2: Research submission for NIH recommendation, tick Jawatankuasa
Penilaian Penyelidikan National Institute of Health (JPP-NIH)
b. Section 1.4.3: Research submission for MREC approval, tick IRB/IEC Medical
Research Ethics Committee (MREC)
c. Section 1.4.6: Research notification to other IRB/IEC, tick the IRB/IEC accordingly, if
applicable
*tick 4-for grant application
*tick 5- for publication or presentation for DG approval - ONLY after completion of
research. Do not tick during research registration.
5. Section 6, click build PDF and submit
6. Section 7. Depends on what we clicked on section 1.4; section 7.1-7.6 appears
accordingly.
7. Subsequent section will only appear after submit Section 6.
a. 7.1: NIH recommendation
b. 7.3: MREC
8. Logout NMRR
9. Contact CRC HKL – to apply for site approval. You will get FORM AK02-01 and AK 02-02.
Prepare details information of PI’s contact number and email, type of research, source of
fund (sponsor/self-sponsor), department involved and another investigator in HKL.
10. Get signature from site HOD involved and Director of HKL for IA-HOD-IA form, AK02-01
and AK 02-02. Director Office will only sign the IA-HOD-IA, when attached with CRC
registration form). For non HKL staff, site approval;(using form AK02-02) and registration
with CRC HKL (form AK02-01) can be done after receive MREC letter. For both HKL and
non-HKL staff, please attach research proposal and other related documents during
submission to Director Office to get HKL Director signature.
11. Prepare IA-HOD-IA, Curriculum Vitae (CV), MREC cover letter, protocol and other
research related documents (to be upload in NMRR).

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12. Login to NMRR once all the documents ready for submission.
13. Go to section 7.1, step 1, upload the relevant research documents, step 2, upload IA-
HOD-IA
14. Section 7.3:
a. step 1, paste the cover letter to the Chairman of MREC explaining the purpose of
your submission.
b. Step 2: upload the cover letter and other relevant research documents
15. Submission is completed. Wait for MREC approval process. Investigator will receive email
from NMRR secretariat regarding registration; JPP-CRC reviewer & MREC reviewer
regarding protocol. If revision needed, to amend accordingly.
16. Inform CRC HKL once receive MREC approval letter from NMRR via email. Email us at
crc.hkl@moh.gov.my for completion of site approval. To attach MREC approval letter,
AK-02-01, AK 02-02, in the email.
17. Start the research only after approval from HKL Director and complete registration with
CRC HKL.

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APPLICATIONS PURPOSE AND RELATED DOCUMENTS REQUIREMENT

Purpose Document requirement

Research Registration in 1. Research Protocol

NMRR 2. Informed Consent and Patients Information Sheet (If
applicable)
3. Data Collection Form (If applicable)
4. IA-HOD-IA (Signature based on Investigator Institution)
5. Investigators’ Curriculum Vitae
6. Good Clinical Practice Certification (Applicable for
Intervention Study)
7. Declaration Conflict of Interest
8. Cover Letter to MREC Chairperson
Registration with CRC 1. AK 02-01
HKL & Study Site 2. AK 02-02
Approval 3. Letter of Agreement (LoA)
4. Clinical Trial Agreement (for ISR study)
5. Temporary Pass Application Form
Requesting Data from 1. AK 02-01
Medical Record 2. AK 02-02
3. Letter of Data Application from Medical Record
Department
Study Renewal, Closure 1. Updated version Declaration Conflict of Interest
and Termination 2. Updated Protocol (If Applicable)
3. Final Study Report (For Study Closure)
4. Termination Memorandum (For Study Termination)
Publication 1. Form P1
2. Manuscript
3. Cover Letter for DG’s Approval Application
Presentation 1. Form P2
2. Abstract
3. Cover Letter for DG’s Approval Application

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LIST OF APPENDICES

1. Circular of Director General of Health no. 10/2015

2. Flowchart for Non-NIH Investigator/Researcher, not requesting for grant using MoH
facilities, data and/or MoH patients
3. Flowchart for Non-NIH Investigator/Researcher, applying for grant using MoH
facilities, data and/or MoH patients
4. Form AK-02-01 & Form AK-02-02
5. Temporary Pass Application Form
6. Final study Report & Termination Memorandum
7. P1 and P2 forms
8. Cover Letter for DG’s Approval Application for Publication and Presentation

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Appendix 1: Circular of Director General of Health no. 10/2015

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Appendix 2: Flowchart for Non-NIH Investigator/Researcher, not requesting for
grant using MOH facilities, data and/or MOH patients.

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Appendix 3: Flowchart for Non-NIH Investigator/Researcher, applying for grant
using MOH facilities, data and/or MOH patients

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Appendix 4.1(a): Form AK-02-01 page 1

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 Appendix 4.1 (b): Form AK-02-01 page 2

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Appendix 4.2(a): Form AK-02-02 page 1

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 Appendix 4.2(b): Form AK-02-02 page 2

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Appendix 5: Temporary Pass Application Form

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 Appendix 6.1(a): Study Final Report Form

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Appendix 6.1(b): Study Final Report Form

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 Appendix 6.2(a): Study Termination Memorandum

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Appendix 6.2(b): Study Termination Memorandum

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 Appendix 7a: P1 Form

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Appendix 7b: P2 Form

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 Appendix 8 (a): Cover Letter for DG’s Approval Application for Publication

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Appendix 8 (b): Cover Letter for DG’s Approval Application for Presentation

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REFERENCES

1. Lim TO, Asmaliza SI, Goh PP, Michael AJ, Hon YK, Thandapani R, Rahilah AR, Teoh SC.
The National Medical Research Register-a vital link between current and future
research. Med J Malaysia. 2010 Jun;65 Suppl A:124-7. PMID: 21488472.
2. Circular of Director General of Health no. 10/2015
3. National Institute of Health Guidelines for Conducting Research in Ministry of Health
Institutions and Facilities. 2015
4. Malaysian Guidelines on The Use of Human Biological Samples for Research.
Accessible from
http://www.crc.gov.my/wpcontent/uploads/2016/07/Guideline_on_Human_Tissue_i
n_Clinical_Research.pdf
5. Guidelines for Ethical Review of Clinical Research or Research involving human
subjects
6. NMRR website, Patient Information Sheet and Inform consent, Accessible from
https://www.nmrr.gov.my/fwbPage.jsp?fwbPageId=NMRR_UserInstruction
7. ICR Website, template for letter of agreement, Accessible from
http://www.crc.gov.my/?s=template+of+agreement&lang=en
8. Clinical Trial Agreement, Managing the relationship between a study sponsor and an
institution, The Ohio State University, Center for Clinical and Translational Science.
9. Guideline on Study Renewal, National Medical Research Register, Accessible from
https://www.nmrr.gov.my/fwbPage.jsp?fwbPageId=NMRR_UserInstruction

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