|Head of Unit||YBrs. Dr. Hjh Salina Abdul Aziz
|Phone||603 – 26155555 ext 6262|
|Crc Hkl / Clinical Research Centre HKL|
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).
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.
To steer Hospital Kuala Lumpur towards becoming a leading clinical research institution in Malaysia
To improve patients’ health outcomes through ethical and quality clinical research
5. OBJECTIVES AND FUNCTIONS
1. Ensure the implementation of ISR clinical research at HKL follows the research ethics set out in the Malaysian GCP standards so that ethical and quality research can be produced
• Monitor & ensure ISR clinical research conducted at Kuala Lumpur Hospital follows research ethics as prescribed by GCP.
• Monitor the use of ISR facilities such as refrigerators, incubators and centrifuges.
• Update the ISR research database registered with the HKL CRC.
2. Coordinate research at Kuala Lumpur Hospital for IIR research and ensure that the implementation of IIR clinical research meets the requirements of the Malaysian GCP standard.
• Monitor and ensure that all IIR research at Kuala Lumpur Hospital is registered with CRCHKL, get the ethical approval of the Medical Ethics and Research Committee (JEPP), the consent of the department heads and the permission of the director of Kuala Lumpur Hospital before data collection begins.
3. Provide research consulting services.
• Provide research consulting services that include the preparation of research proposal papers, research methodology, data management and collection, data analysis, manuscript writing as well as publication / presentation of research results and research study registration problems on the NMRR website.
4. Review and review research proposal papers from the National Evaluation & Research Committee.
• Discuss the proposal paper in the HKL level research committee meeting to expedite the review of the research proposal paper with low risk (minimal risk).
5. Provide training services related to research at the hospital level
• Provide training services to improve quality in research results.
5.2 FUNCTIONS OF A HOSPITAL CRC (HCRC)
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;
2. To assist in the registration of research protocol to NMRR (National Medical Research Register) and application of grants for research;
3. To participate in clinical trials and another research initiated or coordinated by the national CRC;
4. To promote research through capacity building.
♦ Research: Assist researchers in clinical research according to customer needs so that research conducted at HKL according to Standard Good Clinical Practice (GCP).
♦ Consulting Services: Provide research consulting services according to the needs of researchers.
♦ Training Services: Ensure that courses organized by the Clinical Research Center, HKL are conducted annually for researchers at HKL.
7. ORGANIZATION CHART
8.1 Reseacrh Consulation Clinic(RCC)
• We offer RCC every Mondays, Tuesdays, Thursdays and Fridays from 9am – 4pm (excluding Public Holidays)
• Please contact CRC HKL to make an appointment or if investigators require an assistance regarding research. Researchers will be given the date and time of the appointment depending on the presence of CRC staff / officers.
• 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.
• Customers are advised to bring their own laptops if they need internet access during consultation.
• CRC HKL reserves the right to cancel any appointments; notices will be sent beforehand to investigators regarding any rescheduling for the RCC.
8.2 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) are as below:
1.DR KARINA KOH
2.DR LEE JEN VEN
3. DR DURATUL’AIN MOHAMAD NAZRI
4. DR NOOR HIDAYU WAHAB
5. DR NOR ALIYA AYUB
6. DR RAJ KUMAR SEVALINGAM
7. DR NADIAH ISMAIL
8. DR SITI ZUBAIDAH OTHMAN
9. DR NUR AISYAH ABDUL RAHIM
10. VARAALAKSHMY GOKILAVANAN
11. DR PREM A/L VENUGOPAL
12. MS SITI SALEHA ADNAN
8.3 Clinical Trial Unit
Our Clinical Trial Unit is situated at Level 3, Specialist Complex & Ambulatory Care Centre Hospital Kuala Lumpur (SCACC HKL). It was established to provide additional facilities for investigators to conduct clinical trials in HKL. It has been functioning since November 2019 and is equipped with the below;
• 1 Consultation room with 1 patient bed & 1 consultation table
• 2 Micro centrifuges
• 1 Infusion Pump
• 1 Vital Sign Monitor
• 1 Digital Weighing Scale
• 1 ECG Machine
• 1 Computer Desktop
8.4 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. Below are the medical equipment available:
1. Medical Fridge/Freezer - Panasonic 340 L/82 L capacity
2. Medical Freezer -20° to -30 °Celcius Panasonic 482 L capacity
3. Medical Freezer -80°Celcius Panasonic 519 L capacity
4. Medical/Investigational Product (IPFridge (ETS): Fridge Temp Range: 2-8 Celcius
8.5 CRC HKL Training Room
• CRC HKL offers training room for investigators from all departments in HKL to conduct research related courses and training.
• Our Training Room is equipped with computers and projector, this training room can accommodate up to 18 participants at one time.
Link for application usage of CRC facilities:
The investigators may fill in the booking form via the link or QR Code below for the following matters:
1. Training Room Reservations
2. Meeting Room Reservations
3. Get an appointment for a Research Consultation Clinic
4. Clinical Trials Unit Reservations.
Please click here:https://mub.me/Ha9
RESEARCH AND TRAINING
9.1.1 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 Malaysia10/2015: 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.
9.1.2 Investigator Initiated Research (IIR)
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), and 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. 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 call us at 603-26155555 ext.: 6262. Attached is the document that investigator need to fill for online registration.
Flow Registration for Conducting Research in Hospital Kuala Lumpur
9.1.3 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. 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 call us at 603-26155555 ext.: 6262. Attached is the document that investigator need to fill for online registration.
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(Refer to Director General Circular No 10/2015). 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.
• 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
• Approval of all research presentations (oral and poster) must be obtained from the Director General of Health Malaysia
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.
• CRC HKL is recognized as the ‘Prime Site’ to conduct Industry Sponsored Research (ISR) and Parexel has announced HKL as Site Alliance Member along with 3 other institutes.
• Organizing the 1st HKL Research Day on 22nd September 2016. Until now, Research Day has been organized every year to spark interest among young medical professionals to conduct clinical research as well as celebrate existing researchers and harmonize research culture, especially among healthcare workers at HKL.
• Establishment of Hospital Research Review Committee (HRRC) in May 2014.
HKL Achievement in Research Activities
*Total numbers of research registered with CRCHKL
** Total numbers of ongoing ISR
*** Total numbers of publications by HKL staff
# Data not available
Training list that has been conducted every year by CRC HKL is as below:
1. NMRR Clinic
2. NMRR & Literature Search
3. Sample size calculation workshop
4. Research Methodology Workshop
5. Introduction To Clinical Research Workshop
6. Data Management & Statistics Workshop
7. Critical Appraisal Workshop
8. Good Clinical Practice
9. Microsoft Access Workshop
10. Research Camp
11. Effective Oral & Poster Presentation
12. Manuscript Writing Workshop
Department CME is held once every month.
Manuscript Writing Workshop 2020
Good Clinical Practice Workshop 2020
Deployment of CRC staff during COVID-19 Pandemic