Clinical Research Centre

About Clinical Research Centre

Sunway Medical Centre’s Clinical Research Centre (SunMed CRC) commenced in August 2009 in response to the demand for evidence-based practice as well as SunMed’s wish to participate significantly in medical research. CRC is dedicated primarily towards coordinating all research involving human subjects. Such research studies may be related to:

pharmaceutical products,
medical devices,
medical radiation and imaging,
surgical procedures,
medical records,
biological samples,
and/or epidemiological, social and psychological investigations.

CRC seeks to promote ethical and reliable clinical research according to the international and local Good Clinical Practice (GCP) standards. We bridge communication between investigators and their counterparts; and assist with feasibility assessments conducted by interested parties. Apart from facilitating SunMed to secure research projects, we assist in documenting and tracking progress of the clinical researches conducted. In response to the demand for evidence-based clinical research, we seek to increase participation of SunMed and to contribute significantly to the health and research industry.

VISION

To be the leading and pioneering centre of excellence in ASEAN region for research in a private hospital.

MISSION

To create a sustainable research ecosystem in Sunway Medical Centre by enabling medical staff and professionals to learn and discover with the goal to provide the best patient care.

GOAL

To set up a Clinical Research Centre (CRC) for the conduct of quality clinical trials and research according to Good Clinical Practice (GCP) for the advancement of medicine and to improve Quality of Life for the patients.

OBJECTIVES

Set up a strong governance structure within Clinical Research Centre (CRC) to facilitate communication, approval process and quality research conducts which benefits and improves the quality of life for the patients.
To set up comprehensive infrastructure and facilities to support research.
Foster strong research culture among consultants, allied healthcare partners and nursing staffs, and establish research identity.
Establish SunMed as partner of choice for research collaboration among CROs, Industry, Academia & Community.

SERVICES

Clinical Research Centre (CRC), established within Sunway Medical Centre, is essential to the conduct of clinical research initiated in SunMed and therefore the facilities and resources are made available to meet the needs of sponsors/contract research organization (CRO), investigators, and all subjects. Such services include:

Feasibility Studies
CRC assists consultants to review feasibility of protocols received from pharmaceutical companies or CROs, taking into consideration of the resources, patient pool, patient indication, facilities and services required in conducting the study in an institution.
Ethics Review
We have an institutional committee, the Sunway Medical Centre Independent Research Ethics Committee (SREC) constituted of medical professionals and non-medical members, whose responsibility is to ensure the rights, safety and well-being of human subjects involved in a clinical trial. It is compulsory for all studies involving human subjects at SunMed to be reviewed and approved by SREC for conduct.
Legal Review
We have in-house legal advisor that review the provisions of the agreements involved.
Pre-Clinical Trial Organising and Planning
CRC reviews the trial design and procedures to ensure that SunMed has the expertise and facilities to conduct the relevant procedures. CRC liaises and discusses with relevant departments and consultants on the protocol procedures to ensure any concerns are dealt with efficiently.
Clinical Trial Operations
Managing key deliverable issues, personnel, data, finance and operational matters in line with hospital policies to meet sponsor/CRO’s, GCP and regulatory requirements.
Site initiation and closure
We provide venue for site initiation and closure. CRC ensures that all pre-initiation and initiation procedures are performed accordingly to meet GCP and regulatory requirements.

ORGANIZATION CHART

INDUSTRY SPONSORED RESEARCH (ISR)

Active Clinical Trials

The list of clinical trials that are currently active at Sunway Medical Centre. For those who are interested to participate in the current clinical trials, please contact us.

No.	Study Title	Targeted Patients	Recruitment Status
1.	A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon + SOC vs. Placebo + SOC in Hospitalized Adult Patients with Moderate to Severe COVID-19	Hospitalized adult patients with moderate to severe Covid-19	Recruiting
3.	A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 versus Best Available Therapy in Subjects with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Count <50,000/μL)	Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia	Recruiting
3.	MANIFEST-2: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI‑0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients	Patients with Myelofibrosis	Recruiting
4.	KontRASt-02: A Randomized, Controlled, Open-label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 versus Docetaxel in Previously Treated Subjects with Locally Advanced or Metastatic KRAS G12C Mutant Non-Small Cell Lung Cancer	Patients with non-small cell lung cancer	Recruiting
5.	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in addition to R-CHOP versus R-CHOP in Previously Untreated, High-Intermediate and High-risk Patients with Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)	Patients with newly-diagnosed diffuse large B-cell lymphoma	Recruiting
6.	A Multicenter, Double- blind, Randomized, Parallel-group, Placebo-controlled Study to Assess the Safety and Preliminary Efficacy of SIR1-365 in Patients with Chronic Prostatitis Chronic Pelvic Pain Syndrome	Patients with chronic Prostatitis chronic Pelvic Pain Syndrome	Recruiting
7.	A Phase III, Open-Label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab Administered via On Body Delivery System in Patients with EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy (PALOMA-3)	Patients with Metastatic Non-Small Cell Lung Cancer (Stage 4)	Recruiting
8.	A Randomized, Double-blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer	Patients with lung cancer	Recruitment Closed
9.	A Prospective, Multicentric, Single Arm Study to Evaluate the Safety and Efficacy of the Unity-B Biodegradable Balloon Expandable Biliary Stent System in Subjects with Biliary Strictures	Patients with biliary strictures	Recruitment Closed
10.	A Phase II, Two-Arm Study to Investigate Tepotinib Combined with Osimertinib in MET Amplified, Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy	Patients with lung cancer	Recruitment Closed
11A.	A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older after the Vaccination of 2 Doses of Inactivated Vaccines (Site: SunMed)	Adult patients aged 18 years and older after the vaccination of 2 doses of inactivated vaccines	Recruitment Closed
11B.	A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older after the Vaccination of 2 Doses of Inactivated Vaccines (Site: SMCV)	Adult patients aged 18 years and older after the vaccination of 2 doses of inactivated vaccines	Recruitment Closed
12.	A Phase III, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer	Patients with bladder cancer	Recruitment Closed

INVESTIGATOR INITIATED RESEARCH (IIR)

RESEARCH OUTPUT

No.	Title of Publication/Presentation	Journal/ Conference	Author & Co-Author	DOI/LINK
1.	Utility of Lung Perfusion SPECT/CT in detection of pulmonary thromboembolic disease: Outcome analysis	Nuclear Medicine and Molecular Imaging	Tan Teik Hin and Rosmadi Ismail	Click here to read more
2.	Aggregatibacter actinomycetemcomitans as the Aetiological Cause of Rheumatoid Arthritis: What Are the Unsolved Puzzles?	Toxins	Sung Cheng Looh, Zoey May Pheng Soo, Jia Jia Wong, Hok Chai Yam, Sook Khuan Chow, Jung Shan Hwang	Click here to read more
3.	Analysis of genetic variants in myeloproliferative neoplasms using a 22-gene next-generation sequencing panel	BMC Medical Genomics	Jaymi Tan, Yock Ping Chow, Norziha Zainul Abidin, Kian Meng Chang, Veena Selvaratnam, Nor Rafeah Tumian, Yang Ming Poh, Abhi Veerakumarasivam, Michael Arthur Laffan & Chieh Lee Wong	Click here to read more
4.	Comparison of voxel S-value methods for personalized voxel-based dosimetry of Lu-DOTATATE	Medical Physics	Keon Min Kim, Min Sun Lee, Min Seok Suh, Haniff Shazwan Muhd Safwan Selvam,Teik Hin Tan,Gi Jeong Cheon, Keon Wook Kang, Jae Sung Lee	Click here to read more
5.	The lived experiences of a COVID‑19 immunization programme: vaccine hesitancy and vaccine refusal	BMC Public Health	Nee Nee Chan, Khang Wei Ong, Ching Sin Siau, Kai Wei Lee, Suat Cheng Peh, Shakila Yacob, Yook Chin Chia, Vei Ken Seow and Pei Boon Ooi	Click here to read more
6.	Bloodstream infections in solid tumour malignancy: Clinical outcomes and prognostic factors.	Infectious Journal of Infection Diseases	Author: A.G. Ong, S.Y.Chan, X.Y. Lim, S. Md Hanapiah, A.N.M.F. Ahmat, E. Kumolosasi, F. Islahudin (Co-Author from TCM, SunMed)	Click here to read more
7.	Prevalence of Foot Deformity among Urban Young Working Women	Journal of Foot and Ankle Surgery (Asia Pacific)	Yeok Pin Chua, Wei Jing Tan, Aik Saw	Click here to read more
8.	177Lu-DOTATATE Dosimetry for Normal Organs and Tumors with Multiple Voxel S-Value Approach	Journal of Nuclear Medicine	Keon Min Kim, Min Sun Lee, Min seok Suh, Teik-Hin Tan, Haniff Shazwan Muhd Safwan Selvam, Gi Jeong Cheon, Keon Wook Kang and Jae Sung Lee	Click here to read more
9.	Rare incident of newborn with large unilateral neck swelling following multiple nuchal cord	OGSM 2021	Kannappan Palaniappan	Contact CRC to obtain a copy of the abstract
10.	Pre Treatment Semen Parameters among men with oncology diseases. A restrospective study from 2015 to 2020 at Sunway Fertility centre	OGSM 2021	Dr. Kannappan Palaniappan, Fairuza Munirah, Yogeswari Muthu	Contact CRC to obtain a copy of the abstract
11.	Motivation for Risk Information Seeking About COVID-19 Among Healthcare Workers: Cross-sectional Survey Study	2021 Biennial World Communication Association Conference 12-18, July 2021	Yee Chin Law, Jen Sern Tham	Contact CRC to obtain a copy of the abstract
12.	Racial variation on semen parameters in men who present with infertility	OGSM Virtual Congress 2021	Soo Bee Chung, Kannappan Palaniappan	Contact CRC to obtain a copy of the abstract
13.	A rare case of pulmonary aspergillosis with non-tuberculous mycobacterium Tuberculosis (NTM-PD)	Congress of the International Society for Human and Animal Mycology (ISHAM Asia 2021) Asia Fungal Working Group	Ooi Keat TAN, Yun Fong NGEOW, Hien Fuh NG, Col Lin LEE, Chee Loon LEONG, Chee Sian KUAN, Muhammad Nazri, Yvonne ZHOU, Liza Ahmad FISAL, Siu Joo Beh	Contact CRC to obtain a copy of the abstract
14.	Association of autophagy with KRA Mutation and clinic pathological variables and its prognostic value in colorectal cancer patients	Malaysian Journal of Pathology (Accepted)	Awi NJ, Yap HY, Armon S, Low JSH, Peh, KB, Peh SC, Lee CS, Teow SY	Click here to read more
15.	Interplay of autophagy and cancer stem cells in hepatocellular carcinoma	Molecular Biology Reports	Magdelyn Mei‑Theng Wong, Hui‑Yin Chan, Norazlin Abdul Aziz, Thamil Selvee RamasamyJan‑Jin Bong, Ewe Seng Ch’ng Subasri Armon, Suat‑Cheng Peh, Sin‑Yeang Teow	Click here to read more
16.	Extended Whole-body Ga-68 DOTATATE PET-CT in evaluating Tumour-Induced Osteomalacia: Case report and review of literature	Nuclear Medicine and Molecular Imagining	Teik Hin Tan, Ew-Jun Chen, Ming Tsuey Chew , Ping Ching Chye , Ming Wong	Click here to read more
17.	The superior Quantitative Analysis of xQuant Reconstruction Algorithm in SPECT/CT	3rd International Forum on Advances in Radiation Physics (IFARP-3)	Ew-Jun Chen, Hanif Safwan,Teik Hin Tan, Ming Tsuey Chew	Contact CRC to obtain a copy of the abstract
18.	Incidental finding of hepatocellular carcinoma using Ga-68 PSMA PET-CT: Future use for detection and theranostics?	19th Asian Oceanian Congress of Radiology (AOCR) 2021	Ew-Jun, Teik Hin Tan, Nik Muhd Aslan	Contact CRC to obtain a copy of the abstract
19.	Detection of synchronous phosphaturic mesenchymal tumour by ‘extended’ wholebody Ga-68 DOTATATE PETCT in Tumour-Induced Osteomalacia: a case report.	19th Asian Oceanian Congress of Radiology (AOCR) 2021	Teik Hin Tan, Ew-Jun Chen, Ming Tsuey Chew , Ping Ching Chye , Ming Wong	Contact CRC to obtain a copy of the abstract
20.	A Novel Supraretinacular Endoscopic Carpal Tunnel Release: Surgical Technique, Clinical Efficacy and Safety (A Series of 48 Consecutive Cases)	Journal of Hand Surgery Global Online	Kok Kheng Teh, Jayaletchumi Gunasagaran, Ch’ng Hwei, Choo Tunku SaraAhmad	Click here to read more
21.	Baseline Dataset for Gastric Emptying Study Based on Malaysian Local Diet-Pilot Study	19th Asian Oceanian Congress of Radiology	Haniff Syazwan and Dr. Tan Teik Hin	Contact CRC to obtain a copy of the abstract
22.	“Palliative care knowledge and attitudes towards caring for terminally ill patients among nurses: What are the factors associated with positive attitudes and better knowledge?”	17th EAPC (European Association for Palliative Care) World Congress in October 2021	Julia Ho, Y.K. Lum, .S.M.Meseng, V.kameisan,, Y.P.Cho, Hayati Yaakup	Contact CRC to obtain a copy of the abstract
23.	Effectiveness of Dispensing Error Reduction Strategies: A 6-Year Retrospective Review	International forum of quality and safety in healthcare Asia: A virtual conference	Wan Mun Yi, Chow Hoong Seng, Tan Min Anne, Evelyn Yap Hui Xian	Contact CRC to obtain a copy of the abstract
24.	Malaysian Consensus statement on FDG PET -CT reporting format for lymphoma	Med J Malaysia	Teik Hin Tan, Teck Hiat Wong, Alex Chin Hoe Khoo, Thanuja Mahaletchumy, Cen Siew Ng, Mohd Wajdi Ghazali	Contact CRC to obtain a copy of the abstract
25.	A qualitative study on nurses’ attitudes and perceptions towards caring for terminally ill patients: What challenges do nurses face and what do they regard as important in the care of the dying?	14th Asia Pacific Hospice Council Conference in November 2021	Julia Fee Voon Ho, Nur Syafiqah Marzuki, Caryn Shiao-Yen Khoo, Hayati Yaakup	Contact CRC to obtain a copy of the abstract
26.	Mechanical Analysis of Five Methods of Tibiotalar Arthrodesis Using Screw Fixation technique: A Cadaveric Study	Journal of Foot and Ankle Surgery (Asia Pacific)	Yeok Pin Chua, Weng Kong Low, Rukmani kanthan Shanmugam, Aik Saw, Mark C Blackney	Click here to read more
27.	Symptom Prevalence and Place of Death Preference in Advanced Cancer Patients: Factors Associated With the Achievement of Home Death	American Journal of Hospice & Palliative Medicine	Julia Fee Voon Ho, Nur Syafiqah Marzuki, Viknaswary Kaneisan, Eunice Wan Wen Pui, and Hayati Yaakup	Click here to read more
28.	Clinical and Epidemiological Characteristics of Patients Seeking COVID-19 Testing in a Private Centre in Malaysia: Is There A Role for Private Healthcare in Battling the Outbreak?	PLOS ONE	Chow YP, Chin BHZ, Loo JM, Moorthy LR, Jairaman J, Tan LH, et al.	Click here to read more
29.	Joint Angle Control of a Cable-Actuated Soft Hand Exoskeleton (Conference Paper)	International Conference on Robotics and Artificial Itelligence (ICRAI)	Talha Shahid, Darwin Gouwanda, Tayyab Shahid, Alpha A. Gopalai, Surya G. Nurzaman, Teh Kok Kheng	Contact CRC to obtain a copy of the abstract
30.	Development of an Electrooculogram-activated Wearable Soft Hand Exoskeleton	2020 IEEE-EMBS Conference on Biomedical Engineering and Sciences (IECBES)	Talha Shahid, Darwin Gouwanda, Tayyab Shahid, Alpha A. Gopalai, Surya G. Nurzaman, Teh Kok Kheng	Contact CRC to obtain a copy of the abstract
31.	Quantitative Analysis of xQuant Reconstruction Algorithm In SPECT/CT	The Malaysian Journal of Pathology	Ew-Jun Chen, Haniff Shazwan Safwan Selvam, Teik HinTan, Ming Tsuey Chew	Contact CRC to obtain a copy of the abstract
32.	Current Update of Laboratory Molecular Diagnostics Advancement in Management of Colorectal Cancer (CRC). [KRAS 2018]	Diagnostics (Basel)	Siew-Wai Pang, Noel Jacques Awi, John SengHooi Low, SuatCheng Peh, SinYeang Teow	Contact CRC to obtain a copy of the abstract
33.	Morphine use for cancer pain: a strong analgesic used only at the end-of-life? A qualitative study on attitudes and perceptions of morphine in patients with advanced cancer and their caregivers	Palliative Medicine (International peer-reviewed journal, Impact factor	Julia Fee Voon Ho, Hayati Yaakup, Grace Sook Hoon Low, Siew Lih Wong, Lye Mun Tho, Seng Beng Tan	Click here to read more
34.	Ga-68 PSMA and F18 FDG PET-CT in Renal Cell Carcinoma" CNM Interesting Image [PSMA 2019]	Clinical Nuclaer Medicine	Ew-Jun Chen; Teik Hin, Tan; Ming Tsuey Chew; Ping Ching Chye	Click here to read more
35.	High expression of LC3A, LC3B and p62/SQSTM1 autophagic proteins in human colonic ganglion cells	The Malaysian Journal of Pathology	Noel Jacques Awi, Subasri Armon, KaikBoo Peh, Suat Cheng Peh, SinYeang Teow	Click here to read more
36.	Bonuses and pitfalls of a paperless drive-through screening and COVID-19: A field report	Journal of Microbiology, Immunology and Infection	Elly Lee, Nurul Yaqeen Mohd Esa, Tong Ming Wee, Chun Ian Soo	Click here to read more
37.	The effect of mindfulness-based training on stress, anxiety, depression and job satisfaction among ward nurses: A randomized control trial	J Nurs Manag	Sajed Faisal Ghawadra, Khatijah Lim Abdullah, Wan Yuen Choo, Mahmoud Danaee, Cheng Kar Phang	Click here to read more
38.	Superscan: Superiority of xSPECT/CT over OSEM SPECT/CT in bone scans of prostate cancer patients.	Radiation Physics and Chemistry	E.J.Chen, T.H.Tan, M.T.Chew	Click here to read more
39.	Improving Superscan Diagnostic Accuracy in Prostate Cancer patients using xSPECT Bone Scan	2nd International Forum ADvanced Radiation Physics (IFARP-2); 3-4 Dec-2019	E.J.Chen, T.H.Tan, M.T.Chew	Contact CRC to obtain a copy of the abstract
40.	From Driver Mutations to Genomic Classifications: Current & Future Perspectives on Myeloprolierative Neoplasms	Malaysian Journal of Medicine & Health Sciences	Tan Jaymi , Chow Yock Ping , Norziha Zainul Abidin , Chang Kian Meng, Veena Selvaratnam, Nor Rafeah Tumian , Poh Yang Ming , Abhi Veerakumarasivam , Michael Laffan, Wong Chieh Lee	Contact CRC to obtain a copy of the abstract
41.	A multicentre study on the identification of novel variants and in silico analysis of their functional significance in myeloproliferative neoplasms	17th Malaysian Society of Haematology Annual Scientific Meeting, 10th-12th September 2020, Kuala Lumpur.	Tan Jaymi, Chow Yock Ping, Norziha ZA, Abhi Veerakumarasivam,Wong Chieh Lee	Contact CRC to obtain a copy of the abstract
42.	Smoking amidst the COVID-19 Pandemic - the invisible threat ?	Med J Malaysia Vol 75 No 3 May 2020	Anand Sachithanandan	Click here to read more
43.	Pneumocephalus and air travel: an experimental investigation on the effects of aircraft cabin pressure on intracranial pressure	Scientific Report (Nature Research)	Ee Lim, Boon Leong Lan,Ean Hin Ooi & Hu Liang Low	Click here to read more
44.	Association of autophagy with KRA Mutation and clinic pathological variables and its prognostic value in colorectal cancer patients	1st MACR Scientific Conference 2019	Noel Jacques Aqi, Hooi-Yeen Yap, Subasri Armon, Kaik-Boo Peh, John Seng-Hoii Low, Suat-Cheng Peh, C Soon Lee, Sin Yeang Teow	Contact CRC to obtain a copy of the abstract
45.	Prolonged release (PR) oxycodone/naloxone (OXN) for cancer pain (CP) & its impact on bowel function, safety & quality of life (QoL): systematic review	ESMO Asia	Sam H Ahmedzai*, Alfredo Covarrubias-Gómez, Gustavo De Simone, Michael Green, Lizanne Langenhoven, Brian Le, Kyung-Hee Lee, Henry Lu, Patricia Neo, Carlos Rodriguez, Karina Rodrigues Subi, Hayati Yaakup, Stanley Ka Tung Yu, Charlotte Minnaert, Yacine Hadjiat	Contact CRC to obtain a copy of the abstract
46.	Colon Carcinogenesis: The Interplay Between Diet and Gut Microbiota	Frontier in Cellular and Infection Microbiology	Yean Leng Loke, Ming Tsuey Chew, Yun Fong Ngeow, Wendy Wan Dee Lim and Suat Cheng Peh	Click here to read more
47.	ID 89. Derivation of Quality Improvement Projects through Clinical Pharmacy Intervention Data to Optimize the Provision of Clinical Pharmacy Services in a Tertiary Private Hospital	Journal of Pharmacy & Bioallied Sciences. 2020 Supplement, Vol. 12, p883-883. 1/3p.	Khor Chiew Min, Madeline; Tan Siew Kuan; Choong Wee Nei; Gan Hooi Ping	Contact CRC to obtain a copy of the abstrac
48.	Posterior subthalamic area deep brain stimulation for treatment of tremor and dystonia in Wilson's disease [SUNMED Funded]	Brain Stimulation	Hu Liang Low, Sian K. Alexander, Anjum Misbahuddin, Godfrey T. Gillett	Contact CRC to obtain a copy of the abstrac
49.	Implication of laboratory molecular diagnostics advancement in clinical management of colorectal cancer	Cancers. MDPI	Siew-Wai Pang, Noel Jacques Awi, John Seng-Hooi Low, Suat-Cheng Peh, Sin-Yeang Teow	Contact CRC to obtain a copy of the abstract
50.	Comparison of posterior subthalamic area deep brain stimulation for tremor using conventional landmarks versus directly targeting the dentatorubrothalamic tract with tractography	Clinical Neurology and Neurosurgery	Hu Liang Low, Mohd. Nasir bin Mohd Ismail, AhsanTaqviaJacquie, Deeb, CharlotteFuller, Anjum Misbahuddin	Contact CRC to obtain a copy of the abstract
51.	The local thermal effect of using monopolar electrosurgery in the presence of a deep brain stimulator: cadaveric studies on a lamb brain	Journal of Clinical Neuroscience	Geoffrey Tipper, Ahsan Ali Taqvi, Arvind Singh, Ute Pohl, Hu Liang Low	Contact CRC to obtain a copy of the abstract
52.	The Effects of a One-day Mindfulness-based Intervention on Psychological Distress for Caregivers of Children with Speech language Pathology: A Pilot Randomized Control Trial	Malaysian Journal of Medicine and Health Sciences,	Lee Sze Che, Wan Salwina Wan Ismail, Nik Ruzyanei Nik Jaafar, Phang Cheng Kar, Teh Ewe Eow	Contact CRC to obtain a copy of the abstract
53.	Measured Time and Perceived Time: Crucial Data in Reducing and Managing the Time Spent at the Emergency Department	Journal of Patient Safety and Quality Improvement	Mohd. Nasir bin Mohd. Ismail, Vei Ken Seow	Contact CRC to obtain a copy of the abstract
54.	A Novel Supraretinacular Endoscopic Carpal Tunnel Release: Instrumentation and Technique (Cadaveric Study).	Journal of Hand Surgery Global Online.	Kok Kheng Teh, Ch’ng Hwei Choo, Rukmanikathan Shanmugam, Joanne Hui-ling Ngim, Tunku Sara Ahmad	Contact CRC to obtain a copy of the abstract
55.	Mindfulness-based stress reduction for psychological distress among nurses: A systematic review	J Clin Nurs.	Ghawadra SF, Abdullah KL, Choo WY, Phang CK	Contact CRC to obtain a copy of the abstract
56.	Psychological distress and its association with job satisfaction among nurses in a teaching hospital	J Clin Nurs.	Ghawadra SF, Abdullah KL, Choo WY, Phang CK	Contact CRC to obtain a copy of the abstract
57.	Granulocytes and Mono-nuclear cells from patients with myeloproliferative disorders harbour persistent evidence of DNA damage and TP53 pathway activation that correltaes with Jak-Stat activation	European Hematology Association (13-16 June 2019; Amsterdam)	Andrew Innes, Mark Robinson, Gareth Gerrard, Norziha Zainal Abidin, Soon-Keng Cheong, Chooi Fun Leong, Ping Chong Bee, Jameela Sathar, Letizia Foroni, Michael Laffan, Chieh Lee Wong	Contact CRC to obtain a copy of the abstract
58.	A 3-year Retrospective Analysis of Hospitalized Burn Patients in a Private Hospital in Malaysia	12th Asia Pacific Burn Congress (14-17 Aug 2019; Singapore)	Yock Ping Chow, Loshini R Moothy, Edwin B Tan, Margaret Poh Gaik Leow	Contact CRC to obtain a copy of the abstract
59.	Attitudes and Perceptions of Morphine in Patients with Advanced Cancer and their Family Caregivers: A Qualitative Study.	EAPC 16th World Congress 2019 (23-25 May 2019; Berlin).	Ho, J.F.V., Yaakup H., Low G.S.H., Wong S.L., Tho L.M, Tan S.B.	Contact CRC to obtain a copy of the abstract
60.	The Effectiveness of Educational Interventions in Improving Nurses’ Knowledge towards Antimicrobials in a Tertiary Private Hospital	International Forum on Quality and Safety in HealthCare (18-20 Sep 2019, Taipei)	Lim Xian Ting, Leung Chui Teng, Tan Siew Kuan	Contact CRC to obtain a copy of the abstract
61.	Barriers of Clinical Pharmacist-led Medication Reconciliation for Identified ‘At-risk’ Inpatients Upon Discharge In A Tertiary Private Hospital	International Forum on Quality and Safety in HealthCare (18-20 Sep 2019, Taipei)	Lai Min Yi, Madeline Khor Chiew Min, Tan Siew Kuan	Contact CRC to obtain a copy of the abstract
62.	Effectiveness of Clinical Pharmacist-Led Educational Interventions in Improving Nurses' Knowledge Towards Medication Delivery Via Enteral Feeding Tube	International Forum on Quality and Safety in HealthCare (18-20 Sep 2019, Taipei)	International Forum on Quality and Safety in HealthCare (18-20 Sep 2019, Taipei)	Contact CRC to obtain a copy of the abstract
63.	Development and analytical validation of a custom 22-gene targeted next generation sequencing panel for the detection of somatic mutations in myeloproliferative neoplasms	Malaysia Society of Heamatology (11-13 Apr 2019; Ipoh)	Wong Chieh Lee, Chang Kian Meng, Chow Yock Ping, Norziha Zainul Abidin, Nor Rafeah Tumian, Veena Selvaratnam, Abhi Veerakumarasivam, Michael Arthur Laffan	Contact CRC to obtain a copy of the abstract
64.	Early aggressive nutrition intervention for critically ill patients who are mechanically ventilated in Sunway Medical Centre	25th Malaysian Dietitians' Association National Conference 2019 (23-24 June 2019, KL)	Pei Chee Gan, Wai Hong Lau	Contact CRC to obtain a copy of the abstract
65.	Effectiveness of Clinical Pharmacist-led Educational Interventions in Improving Nurses' Knowledge and Practice towards Medication Delivery Via Enteral Feeding Tube	APHM (29-31 July 2019, Kuala Lumpur Convention Centre)	Ng Mun Yi, Gan Hooi Ping, Ng Qingpei	Contact CRC to obtain a copy of the abstract
66.	Barriers of Clinical Pharmacist-led Medication Reconciliation for Identified ‘At-risk’ Inpatients upon Discharge in a Tertiary Private Hospital	APHM (29-31 July 2019, Kuala Lumpur Convention Centre)	Lai Min Yi, Madeline Khor Chiew Min, Tan Siew Kuan	Contact CRC to obtain a copy of the abstract
67.	Derivation of Quality Improvement Projects through Clinical Pharmacy Intervention Data to Optimize the Provision of Clinical Pharmacy Services in a Tertiary Private Hospital	International Conference on Pharmaceutical Research and Pharmacy Practice (19-20 Oct 2019; KL)	Madeline Khor Chiew Min, Tan Siew Kuan, Choong Wee Nei, Gan Hooi Ping	Contact CRC to obtain a copy of the abstract

CRC Policies and Procedures

Policy number	Policy name	Applicability
SMC-SOS-CORP-CRC-001	Scope of Services	IIR
SMC-GL-CORP-CRC-001	Prepare for an Audit or Inspection	IIR
SMC-GL-CORP-CRC-002	External Grant Application for Investigator Initiated Research (IIR)	IIR
SMC-GL-CORP-CRC-003	Grand Management for Investigator Initiated Research (IIR)	IIR
SMC-SOP-CORP-CRC-007	Request for Research collaboration with SunMed	IIR
SMC-SOP-CORP-CRC-008	SunMed Funding Application	IIR, IISR
SMC-SOP-CORP-CRC-009	Document Control for research Related Documents	ISR, IISR
SMC-SOP-CORP-CRC-010	Protocol Development	IISR (if applicable), IIR
SMC-SOP-CORP-CRC-013	Informed Consent Process	IIR, IISR, ISR
SMC-SOP-CORP-CRC-016	Re-consent process	IIR, IISR, ISR
SMC-SOP-CORP-CRC-017	Taking Informed Assent Process	IIR, IISR, ISR
SMC-SOP-CORP-CRC-019	Research Team Training	IIR, IISR, ISR
SMC-SOP-CORP-CRC-020	Handling of Research Noncompliance	IIR, ISR, IISR
SMC-SOP-CORP-CRC-021	Assisting in Site Initiation Visit for ISR	ISR
SMC-SOP-CORP-CRC-022	Assisting in (COV) for Industry Sponsored Research (ISR)	ISR
SMC-SOP-CORP-CRC-023	Assisting in Archiving in (ISR)	ISR
SMC-SOP-CORP-CRC-027	Safety Surveillance Management	ISR, IISR
SMC-SOP-CORP-CRC-028	Research Sample Management	ISR
SMC-SOP-CORP-CRC-029	Submitting Study Progress Report & End of Research Report	IIR
SMC-SOP-CORP-CRC-030	Laboratory Specimen Handling & Shipment in ISR	ISR
SMC-SOP-CORP-CRC-031	Investigational Product (IP) Management	ISR, IISR
SMC-SOP-CORP-CRC-032	Investigational Product (IP) Dispensing	ISR, IISR
SMC-SOP-CORP-CRC-033	Study Closeout for Investigator Initiated Research (IIR)	IISR (If applicable)
SMC-SOP-CORP-CRC-034	Site Initiation for Investigator Initiated Research (IIR)	IIR
SMC-SOP-CORP-CRC-035	Maintaining Study Documentation & Record Keeping in Industry Sponsored Research	ISR, IISR
SMC-SOP-CORP-CRC-036	Monitoring of Investigator Initiated Research (IIR)	IIR
SMC-SOP-CORP-CRC-037	Handling Feasibility Studies	ISR
SMC-SOP-CORP-CRC-038	Research Misconduct	ISR, IISR, IIR
SMC-SOP-CORP-CRC-039	Pre -Publication Submission Review	IISR

Request for policies or Standard Operating Procedures, please write to: Head of Department, Clinical Research Centre at sunmed_crc@sunway.com.my .
SunMed employee may access CRC policies and procedures via shared point.
Applicant shall read through the relevant policies and procedures prior to the commencement of your research project.

About SunMed Independent Research Ethics Committee (SREC)

The Sunway Medical Centre Independent Research Ethics Committee (SREC) is a committee established under the authority of Sunway Medical Centre Berhad (SunMed). It evaluates the ethical aspects of research in SunMed, ensuring that they are reliably conducted in accordance with both international and Malaysian standards of ‘Good Clinical Practice’ (GCP).

SREC holds as its primary responsibility the safe-guarding of the rights, safety, and well-being of all research subjects. As per GCP requirements, members of the SREC are drawn from medical and non-medical sectors to ensure sufficient objectivity and independence from SunMed clinicians undertaking the research. The Clinical Research Centre (CRC) is the Secretariat to SREC

Registered with National Pharmaceutical Regulatory Agency (NPRA)

Sunway Medical Centre Independent Research Ethics Committee (SREC) is one of the 3 private hospital among the 13 Ethics Committee Registered with Drug Control Activity (DCA)

Objective

The objectives of SREC are to

protect the rights, safety, dignity and wellbeing of the subjects of research
promote ethical principles in human research
provide special attention to research involving vulnerable subjects and use of genetic testing
facilitate ethical research through efficient and effective review processes
provide competent review and monitoring of human research projects whilst they are active
promote awareness of the ethical conduct of human research

Scope

The scope of the SREC’s operations manual is applicable to all members of SREC and persons conducting research in SunMed. The scope also encompasses the following:

Terms of reference of the SREC which include:

responsibilities,
membership requirements,
terms of appointment,
liability coverage,
conditions of appointment,
offices, quorum & meeting requirements,
use of independent panel and
education of members.
procedure for submitting an application to the SREC for
approval to conduct research projects or to make amendments to a previously SREC approved research,
Reviewing of applications by SREC,
decision-making and the communication of decisions of the SREC,
following up and monitoring of approved research,
SREC documentation and archiving.

SREC Member (Term 2022-2023)

Name	Gender	Earned Degree	Primary Specialty	Occupation	Affiliation With SunMed
Dato’ Dr. Chang Kian Meng (Chairperson)	M	MBBS,MRCP,FRCP,FRCPA (Haem)	Scientific	Consultant Haematologist	Yes
Assoc. Prof. Dr. Quek Kia Fatt (Vice-Chairperson)	M	PhD, FRIPH	Scientific	Lecturer of Community Health, Jeffrey Cheah School of Medicine & Health Sciences	No
Mr. Edwin Tan (Secretary)	M	BSc	Scientific	Senior Manager, CRC	Yes
Ms. Azliana Binti Abu Bakar Sajak	F	BSc, MSC	Scientific	Research Scientist	Yes
Prof. Dr. Abhi Veerakumarasivam	M	PhD (Oncology & Genetics)	Scientific	Professor, Department of Medical Sciences	No
Mr. Lau Ngee Boon	M	NA	Non-scientific	Business Manager	No
Mr. Mah Seng Cheng	M	MCE	Non-scientific	Sales Manager	No
Dr. Felix Yap Boon Bin	M	MD (UNIMAS) MRCP (UK) AdvMDerm (UKM)	Scientific	Consultant Dermatologist	Yes
Ms. Wan Mun Yi	F	Pharmacy	Scientific	Assistant Manager, Pharmacy	Yes
Mr. Ashwin A/L Kumar	M	LL.B	Non-scientific	Senior Manager, Legal Services	Yes
Ms. Amy Khoo Leet Chien	F	LL.B	Non-scientific	Director, Legal Services	Yes
Dr. Jennifer Leong Siew Mooi	F	MBBS (IMU), MCO (UM)	Scientific	Consultant Clinical Oncologist	Yes
Dr. Thangesweran Ayakannu	M	MBBS (Trinidad, West Indies), MLiP (UK), DFFP (UK), MRCOG (UK), PhD (UK), Colposcopist (UK), Laparoscopic Pelvic Surgeon (UK), INTUITIVE Registered Gynaecological Robotic Surgeon (UK), British & Irish Association Registered Robotic Gynaecological Surgeon (UK)	Scientific	Consultant Obstetrics & Gynecology-Oncologist	Yes

Overview of Conducting Research in Sunway Medical Centre

All research projects to be conducted in SunMed MUST obtain research ethic committee and institutional approvals.

Ethics Application

Please refer to SREC Application Guidelines on how to apply:

SREC Form	Checklist
Research Approval Application Form	Research Approval Application Checklist
Research Amendment Application Form	Informed Consent Form & Written Subject Information Checklist
Serious Adverse Event Report Form	Genetic Research Checklist
Research Progress Report Form (SREC)
Research Closure Report Form

Institutional Approval

SunMed Research Request Form (SMRR) completion
Principal investigator is required to complete the SunMed Research Request Form (SMRR) and read the Sunway Anti Bribery and Corruption (ABC) policies together with related CRC policies and procedures. Attach proposal and all written information that you are providing to research subject.

Departmental Approval
Investigator has to approach the related department(s)’ Head for the approval(s). For instance, if your research involving nurses, then you are required to approach the Director of Nursing. If SunMed staff is the target subjects, then you should obtain the approval from Medical Director/Chief Executive Officer (CEO). If you are unsure which department to approach you may contact us.

Departmental Approval for SunMed
Sunway Medical Centre (SunMed) should be done via the link:- https://bit.ly/3ktQAwa

Submitting the SMRR form, Departmental Approval and a copy of your research proposal
Please submit the following to sunmed_crc@sunway.com.my :-
a) Signed and dated SMRR form
b) Signed and dated ABC declaration form (appendix of SMRR)
c) A copy of your recent research proposal with version and date
Kindly ensure all the documents are submitted to avoid delay of your research approval. Please take note that the department approval(s) is/are compulsory for feasibility assessment.

Institutional Approval
This will commence after the completion of feasibility assessment and scientific review. If the project is approved by Sunway CRC Research Board (SRB) the investigator will receive an institutional approval letter.
For Sunway Medical Velocity (SMCV), you are required to complete the Institutional Approval Form.
Research Agreement
Preparation and signing of collaborative research agreement
CRC will contact you if an agreement is required. We may provide the agreement template to the collaborator for review and comment. Once all parties agreed and signed the agreement then only the study could be initiated.

Research Reporting

i. Research Progress Report - Download Here
- Investigator is required to submit research progress report to CRC bi-annually (every 6 months).

ii. End of Research (EOR) Report - Download Here
- Submit end of research report once project is closed in the system within 90 days.

iii. Pre-publication Submission Review - Download Here

Send a copy of your drafted publication materials to sunmed_crc@sunway.com.my prior submission for publication. After publication a copy of the publication shall be submitted to delegated CRC staff. Furthermore, acknowledgement to Sunway Medical Centre is required for funded research. This applicable for any research project that conducted in Sunway Medical Centre.

Note: This ONLY applicable for research project conducted Sunway Medical Centre

Research Non-Compliance & Protocol Deviation Reporting

For Investigator Initiated Research (IIR) which does not involve investigational products (Clinical Trial), submit Research Noncompliance Form to CRC.

For Industry Sponsor Research (ISR) which involves investigational products (Clinical Trial), attach SREC Protocol Deviation Reporting Form.
Reporting Timeline - Minor within 30 days, Major within 7 days

Internship and Attachment

If you are interested to apply for attachment or internship at SunMed CRC, kindly send your application to wongsoy@sunway.com.my with the following documents:

A cover letter addressing to Head of Division, Clinical Research and Medical Education, Sunway Medical Centre
A copy of your resume

Operation hours

7.30 am - 5.30 pm

Inquiry

For any inquiry and feedback, please contact Clinical Research Center (CRC) at sunmed_crc@sunway.com.my.

Contact Us

Address	SunMed Clinical Research Centre, F-03-02, Block F, Sunway Geo Avenue, Jalan Lagoon Selatan, Bandar Sunway, 47500 Selangor
Tel No	+603 8601 1072 +603 8601 1079 +603 8601 1080
Fax No	+603 8601 1069
Email	sunmed_crc@sunway.com.my edwinbt@sunway.com.my