Head of Unit YBrs. Dr. Hjh Salina Abdul Aziz
Phone 603 – 26155555 ext 6262
Email This email address is being protected from spambots. You need JavaScript enabled to view it.
Facebook Crc Hkl / Clinical Research Centre HKL
Deputy Head of Unit Dr Karina Koh (This email address is being protected from spambots. You need JavaScript enabled to view it.)
Administrative Manager Dr Nik Nur Eliza Bt Mohamed (This email address is being protected from spambots. You need JavaScript enabled to view it.)

1. 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).

2. BACKGROUND

            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. 

3. VISION

To steer Hospital Kuala Lumpur towards becoming a leading clinical research institution in Malaysia

4. MISSION

To improve patients’ health outcomes through ethical and quality clinical research

 

5. OBJECTIVES AND FUNCTIONS

5.1 OBJECTIVES

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.

6. CLIENT’S CHART

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. DEPARTMENT SERVICES

8.1 Research Consultation 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 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:

CRC REVIEWERS

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. DR AINA WAHEEDA BINTI MOHAMAD

13. 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

Applications for usage of CTU can be made through the CRC HKL office or can be done online via email. Investigator should fill in the form together with agreement form below and submit to us at This email address is being protected from spambots. You need JavaScript enabled to view it.. CRC HKL will contact you once we approved your application.

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

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 via email to This email address is being protected from spambots. You need JavaScript enabled to view it. or contact us at 03-2615 6262.

 

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.

Application to use CRC HKL facilities or getting an appointment for a Research Consultation Clinic (RCC) can be made through email This email address is being protected from spambots. You need JavaScript enabled to view it. or contact us at 03-2615 6262.

9. RESEARCH AND TRAINING

9.1 Research

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 CRC present. We also present the data on a hospital level during the annual Research Coordinator meeting.

Hence, data on research registration with CRC HKL will be tabulated to represent each clinical department’s performance in research.

Flow Registration for Conducting Research in Hospital Kuala Lumpur

9.1.2 Research Coordinator

• A research coordinator, proposed by head of department, is a person who oversees the overall progress of research activites within a department in Hospital Kuala Lumpur.

• Research Coordinator Responsibilities:

♦ Monitoring every research activities conducted in the department has been registered in NMRR (National Medical Research Register), CRC HKL and approved by the respective Head of Department.

♦ Maintaining the department’s research database.

♦ To assign co-investigator/supervisor from the department for every research conducted by non HKL investigators.

♦ To ensure the non HKL investigators received Temporary Security pass from Unit Keselamatan Polis Bantuan HKL

• The non HKL investigator is encouraged to liaise directly with the research coordinator of the department that involved in the research before starting the data collection.

List of Research Coordinator for 2022:

BIL

JABATAN

NAMA

JAWATAN

NO. EXT

E-MEL

1

Kecemasan

Dr Nurul Liana Binti Roslan

Pakar Perubatan Kecemasan

5322

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2

Perubatan

Dr Saiful Safuan Md Sani

Pakar Perunding Perubatan

5710

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3

Neurologi

Dr Kok Huey Thean

Pakar Perubatan

5400

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4

Dermatologi

Dr Tang Min Moon

Pakar Perunding Dermatologi

1543

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5

Pembedahan Plastik & Rekonstruktif

Mr (Dr) Koh Khai Luen

Pakar Bedah Plastik

6677

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6

Psikiatri & Kesihatan Mental

Dr Chee Kok Yoon

Pakar Psikiatri

5770

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7

Nefrologi

Dr Tan Min Hui

Pakar Perubatan & Klinikal Nefrologi

5381/5388

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8

Radioterapi & Onkologi

Dr Muthukkumaran Thiagarajan

Pakar Onkologi

5830

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9

Anaestesiologi & Rawatan Rapi

Dr Arul Sakthi Aruminathan

Pakar Anestesiologi

5160

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10

Neurosurgeri

Dr Priya Sharda A/P Jagdish Mitter

Pakar Neurosurgeri

5190

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11

Urologi

Ms Chang Bing Chi

Pakar Klinikal Urologi

6231

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12

Radiologi

Dr Sarawana Chelwan Muniandy

Pakar Radiologi

5930

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13

Pembedahan Am

Mr Narasimman Sathiamurtrhy

Pakar Perunding Pembedahan Torasik & Am

5211

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14

Bedah Mulut & Maksilofasial

Dr Lee Chee Wei

Pakar Bedah Mulut & Maksilofasial

1266

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15

Perubatan Forensik

Dr Khoo Lay See

Pegawai Sains Forensik

6694

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16

Otorinolaringologi

Mr. (Dr) Rohaizam Bin Japar@Jaafar

Pakar Perubatan ORL

5563

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17

Oftalmologi

Dr Sangeetha A/P Tharmathurai

Pakar Oftalmologi

1479

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18

Ortopedik

Ms Siti Hawa Bitni Tahir

Pakar Perunding Ortopedik

5534

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19

Patologi

Dr Subasri Armon

Pakar Patologi

7586

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20

Genetik

Dr Kavitha A/P Rethanavelu

Pakar Klinikal Genetik

6784

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21

Rehabilitasi

Dr Masyitah Binti Mohammad Khayat

Pakar Perubatan Rehabilitasi

5871

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22

Perubatan Nuklear

Dr Mohd Fazrin Bin Mohd Rohani

Pakar Perubatan Nuklear

5889

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23

Fisioterapi

Ong Hai Choo

Pegawai Pemulihan Perubatan Fisioterapi

7170/6033

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24

Pemulihan Carakerja

Muhammad Sulaiman Bin Samat

Pegawai Pemulihan Perubatan Carakerja

6036/6381

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25

Jabatan Dietetik & Sajian

Nursuhaila Sha'ari

Pegawai Dietetik

6027

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26

Farmasi

Jacqueline Yyong Hui Yi

Pegawai Farmasi

5242

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27

Penyeliaan

Rosdi Bin Zainol

Penolong Pegawai Perubatan

1049 / 1050

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28

Perkhidmatan Kejururawatan

Azliha Minai Rajab

Jururawat Terlatih

1003

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29

Psikologi Kaunseling

Pn Raja Shuhaida Bt Raja Ahmad

Pegawai Psikologi

5971

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30

Unit Kualiti

Dr Denesh Menon

Pegawai Perubatan Pentadbir

6266

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31

OSH

Dr Muhammad Talhah Bin Abdul Kader

Pegawai Perubatan

5302

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32

Rekod/ Casemix

Nur Syazwin Binti Preshahdin

Pegawai Tadbir (Rekod Perubatan)

6088

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33

Kesihatan Awam

Dr Nadhir Bin Adi Azahar

Pegawai Perubatan

5300

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34

Unit Kejuruteraan

Ir. Akmal Arif Bin Mohammed

Jurutera Elektronik

7439

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35

Kerja Sosial Perubatan

Noor Syuhadah Binti Mokhtar

Pegawai Kerja Sosial Perubatan

5955

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36

Pusat Sumber Transplan Nasional

Dr Diana Binti Mohd Shah

Pegawai Perubatan

03-26810681

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37

Unit Pendidikan Kesihatan

Jamaliah Binti Abd. Rashid

Pereka

5739

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38

Institut Perubatan Respiratori

Dr Syazatul Syakirin Sirol Aflah

Pakar Perubatan Respiratori

03-40232966 (ext 234)

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39

Pusat Darah Negara  (PDN)

Dr Alvina Lau Voon Na

Pegawai Perubatan

03-26132688

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40

Klinik Kesihatan Kuala Lumpur

Dr Narul Aida Binti Salleh

Pakar Perubatan Keluarga

03-26183200 (ext 265)

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9.1.3 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.

9.1.4 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.

Flowchart for the Registration of IIR/ISR in HKL.

 

9.1.5 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(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.

      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 This email address is being protected from spambots. You need JavaScript enabled to view it.

9.1.5 ACHIEVEMENT

⇒ 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

Year

Research Registrationa

Publicationb

Courses/Training

Research Consultationc

2017

275

70

#

#

2018

210

219

#

#

2019

252

149

#

#

2020

231

224

5

304

2021

299

279

14

358

a Total numbers of research registered with CRC HKL

b Total numbers of publications by HKL staff

c Number of Research Consultation given by CRC HKL staff

#  Data not establish yet

9.2 TRAINING

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

Department CME is held once every month.

Takwim for Training 2022

Workshop

Tentative Date

NMRR Workshop

11 January 2022

Effective Oral Presentation

24 February 2022

Research protocol Development :                   Literature Review

15 March 2022

Research protocol Development :                 Research Proposal

16 March 2022

Research Day Hospital Kuala Lumpur

31 March 2022

Translating Research into Practice

21 April 2022

Translating Research into Policy

26 May 2022

Good Clinical Practice (GCP) Workshop

14-16 June 2022

Good Data Management Practice

19 July 2022

Statistical Analysis - Basic

16 August 2022

Statistical Analysis - Intermediate

14 August 2022

GCP Refresher Course

21 September 2022

Manuscript Writing

11-12 October 2022

Data Visualization

15 November 2022

Good Clinical Practice (GCP) Workshop

6-8 December 2022

 

Photo Gallery


                              Good Clinical Practice Workshop 2021


CRC HKL Staff 2021

 

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