CRC Kuala Lumpur

Introduction
Clinical Research Centre Hospital Kuala Lumpur (CRC HKL) ) was established in November 2012. Hospital Kuala Lumpur being the largest hospital under the Ministry of Health Malaysia, the establishment of a dedicated CRC within the hospital was vital to ensure continuous support for the numerous research activities within the hospital. CRC HKL is a branch under National Clinical Research Centre, and a part of the network of 33 HCRCs across Malaysia.

CRC HKL strives to make Hospital Kuala Lumpur a main clinical research hub in Malaysia. We actively assist investigators in various clinical research areas including training, Investigator Initiated Research (IIR), and Industry Sponsored Research (ISR).

Vision
To make Hospital Kuala Lumpur as the main hub for clinical research in Malaysia

Mission
To increase the quality of research in Hospital Kuala Lumpur

Tagline
“Research Today For The Best Healthcare Of Tomorrow”

FUNCTIONS OF A HOSPITAL CRC (HCRC)

1. 1. To support and facilitate research activities in the hospital through the provision of:

a) Database of clinicians interested in research – by interest areas, track record on Industry Sponsored Research (ISR) for Investigator Initiated Research (IIR) and publications

b) Technical support such as statistical analysis

c) Administrative support such as providing research assistants and study coordinators

d) Facility support such as IT, statistical software, and others, and work station

1. 1. To assist in the registration of research protocol to NMRR (National Medical Research Register) and application of grants for research

1. 1. To participate in clinical trials and another research initiated or coordinated by the national CRC

1. To promote research through capacity building

Hospital Kuala Lumpur as a Prime Site
Hospital Kuala Lumpur prides itself as one of the nation’s hospitals with the highest number of Industry Sponsored Research conducted on site. CRC HKL ISR team works closely together with investigators, industry players and also the Clinical Research Malaysia (CRM) team to facilitate the conduct of ISRs in HKL. Our target is to grow and groom our investigators to perform high quality clinical trials. We also facilitate investigators to achieve a shorter feasibility turn-around time, improve start-up timelines and to achieve patient recruitment targets. Other than that, we also provide training courses for investigators interested in Industry Sponsored Research such as Good Clinical Practice Refresher Courses, Patients Recruitment Workshop, NPRA Inspection Workshop, etc.

Hospital Kuala Lumpur is recognised as a Prime Site under the collaboration between CRC-CRM Network and IQVIA since 2014. Prime site is defined as a site targeted for intensified infrastructure and human resources development for improved participation of investigators in conducting clinical trials. Hospital Kuala Lumpur is also known as a Site Alliance Member under the collaborative work with PARAXEL since November 2016. Site Alliance is being recognised by PAREXEL as capable of conducting clinical trials activities with multiple therapy areas and medical expertise in development.

ORGANIZATON CHART

SERVICES
CRC HKL offers a myriad of services that include:

1.	Providing a consultancy service in conducting clinical research in ways of:
		Conducting trainings such as Good Clinical Practice, Introduction to Clinical Research, Biostatistics, and Data Management.
		Providing consultancy service for research methodology, study design, research protocols and statistical analysis
		Conducting Research Clinics to assist healthcare providers with their research
2.	Involvement in clinical research conducted or supported by National Institute of Health (NIH).
3.	Assistance in protocol registration at National Medical Research Register (NMRR) and research grant.
4.	Providing facilities to support and assist clinical research.

Research Consultation Clinic (RCC)

We offer RCC every Mondays, Tuesdays, Thursdays and Fridays from 9am – 4pm (excluding Public Holidays) for any investigators who require assistance with their research. RCC is strictly appointment based and walk-ins are not entertained. Kindly contact CRC HKL if you are willing to make RCC appointment. You will be given confirmation of the appointment date and time accordingly.

Investigators wishing to seek assistance with their study protocols are advised to email the protocols to the respective officers at least 5 days prior to the appointment date to ensure that the consultation we provide meet expectations.

Clients are advised to bring their own laptop if they require internet access during the consultations.

CRC HKL reserves the right to cancel any appointments; notices will be sent beforehand to investigators regarding any rescheduling for the RCC.

CRC HKL Facilities for ISR/IIR

CRC Facility Room
We also offer a range of medical equipments for the processing or storage (short term) of specimen, and storage for temperature sensitive samples or Investigational Products (IP) to Hospital Kuala Lumpur personnel involved in an IIR or ISR project.

CRC HKL will be responsible for the maintenance of the equipment; but the owner(s) of the items stored bear full responsibility for their items and CRC HKL will not be held liable for any damages incurred to any items stored within our facility. Applications can be made through the CRC HKL office or via email to crc.hkl@moh.gov.my.

CRC HKL TRAINING ROOM

Besides of facilities and medical equipment, CRC HKL offers training room for researchers from all departments in HKL to conduct research related courses and training. Equipped with computers and projector, this training room can accommodate up to 18 participants at one time.

Applications for usage of CRC HKL Training room can be made through the CRC HKL office or can be done online via email. Investigator should fill in the form below and submit to us at crc.hkl@moh.gov.my. CRC HKL will contact you once we approved your application.

Training Room Booking Form – CRC HKL

HOSPITAL RESEARCH REVIEW COMMITTEE (HRRC)

Hospital Kuala Lumpur’s HRRC was established in May 2014. It began as one of the implementations of a new framework for research approval in MOH through a pilot study that involved 3 other public hospitals. As of today, nearly all of the MOH hospitals with a HCRC have their own HRRC that reviews minimal risk research submitted through NMRR (http://www.nmrr.gov.my).

HKL HRRC members were recruited from various departments within HKL and currently consist of Consultants, Specialists, Surgeons, and Allied Health Officers. It started off with only 15 members, and has since expanded to 43 members. The meeting is held every week and reviews an average of 4-5 proposals each week. The proposals are assigned by NCRC to the panel via NMRR and HKL HRRC will recommend scientifically sound research to Malaysia Research & Ethics Committee (MREC) for review to obtain ethical approval
Current panel of reviewers (and their respective departments):

  

RESEARCH/TRAINING
Content:

• Research Registration with CRC HKL
• Investigator Initiated Research (IIR) in Hospital Kuala Lumpur
• Industry Sponsored Research (ISR) in Hospital Kuala Lumpur
• Training
• Training Room
• Publications by members of HKL

RESEARCH REGISTRATION WITH CRC HKL

All research involving Hospital Kuala Lumpur staff or using the facilities within the hospital are required to be registered with CRC HKL – both IIR and ISR studies. Research involving HUMAN SUBJECTS (inclusive of medical records) conducted within the Ministry of Health Malaysia must obtain approval from the Medical Ethics Research Committee (MREC) prior to data collection – refer to Surat Pekeliling Ketua Pengarah Kesihatan Malaysia Bil.10/2015: Garispanduan Institut Kesihatan Negara Mengenai Penyelidikan di Institusi dan Fasiliti Kementerian Kesihatan Malaysia (Pindaan 01/2015).

As part of our KPI, we periodically report to National Clinical Research Centre (NCRC) on the research activity within Hospital Kuala Lumpur. This report is on a national level and represents the performance of each hospital with a HCRC present. We also present the data on a hospital level during the annual QA/QI meeting. Hence, data on research registration with CRC HKL will be tabulated to represent each clinical department’s performance in research.

INVESTIGATOR INITIATED RESEARCH (IIR) IN HOSPITAL KUALA LUMPUR

The NIH Guidelines for Conducting Research in MOH Institutions and Facilities (Revision 1/2015) states that all research done within MOH should obtain permission to conduct research at the respective facilities/institutions. To carry out this policy, CRC HKL acts as a gatekeeper of Hospital Kuala Lumpur, ensuring that all research conducted in the hospital have received approvals from MREC, Head(s) of Department, and Hospital Director before data collection for a study can start.

We have streamlined the process for both HKL (permanent) staff, and non-HKL staff. As those under attachment or undergoing training programs (including medical officers under masters training), are not permanently employed in HKL they would be categorised as non-staff.

Investigators can register their study with us either in person at our office, or they can send an application to register their research via email. If you wish to go through the process online, kindly fill in the form below and submit to us the completed form at crc.hkl@moh.gov.my. The registration confirmation and the relevant forms to obtain HOD and Hospital Director approval will be emailed back to you in reply. If you receive no reply from us within 2 working days, kindly resend the email or call us at 603-26155555 ext.: 6262

Research Registration (IIR) Application Form

The flowchart summarises the process of conducting IIR in Hospital Kuala Lumpur:

INDUSTRY SPONSORED RESEARCH (ISR)

As the NIH Guidelines for Conducting Research in MOH Institutions and Facilities (Revision 1/2015) states that all research done within MOH should obtain permission to conduct research at the respective facilities/institutions, CRC HKL acts as a gatekeeper of Hospital Kuala Lumpur, ensuring that all ISRs conducted in HKL have received approvals from MREC, Head(s) of Department, and Hospital Director prior to the start of a study. By collecting and updating the number of ISRs conducted within HKL, we would be able to present the data to the stakeholders and promote HKL as the preferred centre for conducting ISRs. The reports we send out regarding ISR are only in terms of raw numbers and do not disclose confidential information regarding the studies.

Investigators can register their study with us either in person at our office, or they can send an application to register their research to us via email. If you wish to go through the process online, kindly fill in the form below and submit to us the completed form at crc.hkl@moh.gov.my. The registration confirmation and form will be emailed back to you in reply. If you receive no reply from us within 2 working days, kindly resend the email or call us at 603-26155555 ext.: 6262

Research Registration (ISR) Application Form

Below is the flowchart for the Registration of ISRs in HKL.

PUBLICATIONS

Ministry of Health, Malaysia (MOH) has laid out the guidelines which describes the MOH policies governing the conduct of research in MOH institutions and facilities. The policy statements in the guideline are derived from a review of all existing circulars and web documents issued by the MOH. MOH specified:-.

• NMRR Registration of all research that involves MOH personnel OR that is to be conducted in MOH facility OR to be funded by the MOH research grant (Refer to circular (1)KKM/NIHSEC/03/0301-01 dated 5 Sept 2007)
• Review & approval of the research by a designated entity to which authority has been delegated for the purpose
• Research involving human subjects requires prior review and approval by the Medical Research and Ethics Committee (MREC)
• Approval of all research publications, whether in the form of research report, journal article or conference proceeding, by the NIH initially and thereafter by the Director General of Health Malaysia (Refer to circular (18)KKM/NIHSEC/100-1/1/1 dated 4 Jan 2013)
• Approval of all research presentations (oral and poster) must be obtained from the Director General of Health Malaysia (Refer to circular (18)KKM/NIHSEC/100-1/1/1 dated 4 Jan 2013)

Therefore, we encourage all HKL researchers to follow the policies made by MOH i.e. to register their publications/presentations to NIH. Furthermore, NIH will be able to capture the number of publications/presentations made by the MOH staffs and stored in their database. Recently, on 9th April 2018, NIH has come out with the circular on ‘Menambahbaik Kriteria Dalam Prosedur Memperolehi Kelulusan Ketua Pengarah Kesihatan Untuk Penerbitan dan Pembentangan’(KKM/NIHSEC/600-1/1/1 (15)). Basically, NIH recommends adding few criteria into our researchers’ manuscript including of using the updated their P1 form and P2 form for DG’s approval for publication and presentation respectively.

Publications & Achievements

**Kindly refer our e-newsletter

Newsletter CRC HKL
Issue 7, Dec 2020	Issue 6, Dec 2019
Issue 5, Nov 2018	Issue 4, 2018
Issue 3, August 2017	Issue 2, Volume 1,Jan 2017
Issue 1, Volume 1, June 2016

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