Research Pathway in UKM Medical Centre and Clinical Trial Ward Infrastructure and SOPs

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Research Pathway in UKM Medical Centre and
Clinical Trial WardInfrastructure and SOPs

• Prof Dr Cheah Fook Choe
• Professor of Paediatrics (Neonatology)
• Department of Paediatrics
• AND
• Clinical Trial Ward Co-ordinator
• UKM Medical Centre

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Pusat Pengurusan Penyelidikan Inovasi(PPPI)
Centre for Research Instrumentation Management
(CRIM)

• Centred in UKM Bangi
• Formed in January 1995 as Unit Pengurusan
  Penyelidikan and upgraded to Pusat (PPP) on 1
  June 1999, then renamed PPPI
• Main function
• Management of all research activities
• UKM grants
• External grants

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PUSAT PENGURUSAN PENYELIDIKAN INOVASI (PPPI),
UKM
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Tel [phone] / 3096 Fax [phone]
4550Website  http//research.ukm.myEmail
ppupp_at_ukm.my
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PPPI Activities

• Management of
• Administration and Finances of Research
• Conferences (Local International)
• Exhibition of Research Output
• Training / Workshop / Seminars on Research
• Research Database
• Research Publicity
• Innovation and Technology Transfer
• Research Instrumentation
• Publication of Book / Proceeding / Bulletin on
  Research
• Help with Patent Application

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List of Research with Commercial Potential

•    1. Improved Swivel Arm Mechanism      2.
  Temporal Bone Holder      3. Multimedia in
  Education Software on Mathematics      4.
  Paddy Fluidized Bed Drying (BERNAS)      5.
  Chitin Chitosan      6. LNR (Liquid Natural
  Rubber)      7. TPNR (Thermoplastic Natural
  Rubber)      8. Cilibangi (Bangi Cilli)    
  9. Aerobic Fertiliser     10. Smart Traffic
  Light System      11. Fire Proof Key
  Device      12. Herbal Remopain Film for Ulcer
  and Wounds      13. Styrylpyrone Derivatives
  (SPD) The Potential Therapy for Breast
  Cancer      14. Anti-diabetic Pharmaceutical
  Products      15. Tongkat Ali products    

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Research emphasis and focus for UKM status as a
Research University
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RESEARCH MANAGEMENT - UKM Medical Centre
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UKMMC Human Resource

• Lecturer 463
• Professor Assoc Prof - 136
• PhD holders 43
• 22 departments and 3 research centres
• Basic science
• Clinical department
• Teaching Hospital
• 900 bedded (BOR 60 -70)
• 359,365 outpatients
• 36,181 in-patients

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Human Resource

• Establishment of Research Centres
• Appointment as research fellow
• Tissue Engineering, Case Mix and Adv Surg Skill
  Centre
• Cell therapy centre
• UMBI (independent institute)
• Dual appointment at the faculty and research
  centre
• Assessment/promotion according to the
  contribution
• Time-off to write papers
• Research collaboration field work

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FINANCIAL SUPPORT

• Research University
• GUP (Research University Grant
• -start up, promising research, bridging,
  academia-industry collaboration
• OUP (Operational Research University)
• -post-doctoral and fellowships
• PIP (Research Instrumentation)
• Fundamental Research UKMMC
• Up to 750,000 / year
• 20,000/project lecturer/PhD
• 10,000/project masters
• 5,000/project undergraduates
• 2,500/project foreign students

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Funds management and disbursement
Bendahari/Kewangan UKM Med Centre
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FINANCIAL SUPPORT(External Grant)

• MOSTI (Ministry of Science, Technology
  Innovation)
• eScience fund
• MOHE FRGS, ERGS, PRGS, LRGS
• Techno-fund/Agri-based
• A committee to screen the proposal before
  submitting to MOSTI/MOHE
• External fund/grant
• Pharmaceutical company
• NGOs
• Industry
• Management of funds under Bendahari Bhg
  Penyelidikan

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Research by Department
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Distribution of Type of Research
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Health System and Disease burdenProf Dr Syed
Mohd Aljunid
Nic TKP - 7 Kluster dengan
kumpulan-kumpulan
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Biomedical engineeringProf Dr. Mohd Alauddin
Mohd Ali
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Regenerative MedicineProf Dr. Ruszymah Idrus
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Cancer and Stem Cell- Profesor Dr. A Rahman A
Jamal
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Anti-oxidant and metabolismeProfesor Dr. Wan
Zurinah Wan Ngah
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Mechanism of Illness-Profesor Madya Dr. Roslan
Harun
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Natural products-Profesor Dr. Ibrahim Jantan

• Discovery and delivery of medicines
• Profesor Dr. Ibrahim Jantan
• Toxicology
• Dr. Noor Fadilah Rejab
• Novel antibiotics
• Profesor Dr. Noraziah Mohamad Zin

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www.ppukm.ukm.my
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Traditionally, UKM Medical Faculty Research
Committee (RC) and Ethics Committee (EC) used to
be two separate committees. The Research
Committee was responsible for the evaluation of
research proposals from the point of view of
scientific merit and methodology as well as for
the approval of research grants. The RC also
decided whether proposal needed approval from the
EC. The EC on the other hand, evaluated the
research proposal from the point of view of
research ethics to ensure that the rights and
safety subjects were protected
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INFRASTRUCTURE

• Dedicated research lab
• Mainly at the pre-clinical
• GMP lab (in process)
• Tissue Engineering Lab
• Stem Cell Lab
• Service lab
• Majority of research
• Used together with research
• Collaborative research lab
• Inno Bio Sdn Bhd
• Clinical Trial Ward
• Pharmacy support

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CLINICAL TRIAL WARD

• Opened in year 2000
• Managed by MRIS
• Coordinated by a lecturer
• Assisted by 1 Nurse Mgr, 1 KJ, 2 SN, 1 Clinic
  Assistant and 1 clerk
• Located on first floor of Clinical Block UKMMC
• Provides assistance to investigators to run
  clinical trials
• Mainly on healthy/ not ill subjects
• Full facilities for multi-centre drug trials,
  including bioequivalence studies
• Ward facilities
• 6 beds, waiting areas with TV and video
• Consultation room
• Storage for drugs and blood specimens, archive
  room
• Emergency resuscitation facilities
• Telephone, fax, internet

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Research Collaboration

• LOCAL
• Kementerian Kesihatan Malaysia
• Institut Penyelidikan Perubatan (IMR)
• IPT lain, terutamanya USM, UM , UPM dan IMU
• Syarikat faramsiutikal
• National Productivity Centre
• Association of Private Hospitals of Malaysia
  (APHM)
• Malaysian Council for Tobacco Control
• Malaysian Public Health Specialists Association
• National Institute of Occupational Safety and
  Health (NIOSH)
• Department of Safety and Health (DOSH

• Kementerian Pendidikan Malaysia
• Kementerian Pertahanan
• Kementerian Sumber Manusia
• Kementerian Kesihatan Brunei
• Malaysian Palm Oil Board (MPOB)
• Pusat Darah Negara
• Tai Chi Association Wilayah Persekutuan
• Golden Hope Industries
• Malaysian Palm Oil Promotion Council (MPOPC)
• Zoo Negara
• Hospital Jabatan Hal Ehwal Orang Asli
• Jabatan Siasatan Jenayah, PDRM
• Hospital Mata Tun Hussein Onn
• Jabatan Imigresen
• Jabatan Kebajikan Masyarakat, WP

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Research Collaboration

• FOREIGN
• University of New South Wales University
• University for Peace, San Jose, Costa Rica
• Universiti Gadjah Mada Indonesia
• 3M Hospital Information System, USA
• Wellcome Trust, UK
• Syarikat farmasiutikal
• Institute of Biological Research, Barcelona,
  Sepanyol (Dr. Coral Sanfeliu)
• National Institute of Health, Tokyo, Jepun (Dr.
  Kitagawa)
• Department of Biochemistry, University of Western
  Australia, Perth (Professor Dr. George Yeoh)
• Japanese National Institute of Infectious
  Diseases, Tokyo
• Hamamatsu University, School of Medicine, Japan
• Centre fo Gene Analysis Technology (CGAT)

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Research Collaboration

• FOREIGN
• University of Queensland Brain Centre,
• National Neuroscience Institute of Singapore
• University of Melbourne
• University of Dundee Medical Education Centre
• University of Queensland Dentritic Cell Centre
• Mater Medical Research Institute, Queensland,
  Australia
• Southeast Asia Alliance for Tobacco Control
• Rockefeller Foundation
• World Health Organisation (WHO)
• International Labour Office (ILO)
• World Bank
• London School of Hygiene and Tropical Medicine
• Asia Pacific Academic Consortium for Public
  Health (APACPH)

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Recent Collaboration
Research collaboration through MoU / MoA

• ANZ Burns Association
• Newcastle University, Australia
• Australia Advanced School of Medicine
• Great Ormond Street Hospital, United Kingdom

• Inno Bio Sdn Bhd
• Prince Court Hospital
• Institute Jantung Negara
• UNU-IIGH

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E.g. Clinical Trials in progress Rivarox study
rivaroxaban in acute coronary syndrome
Cardiology (JJ) Aspire trial Aripiprazole in
schizophrenia Psychiatry (Otsuka) LUX-Lung 3
Phase 3 trial Rx for lung adenoCa Oncology
(Boehringer) BASILEA WSA-CS-008 New drug vs
caspofungin f/b voriconazole in Rx candidemia
Haematology (Basilea Pharma) E.g. Recently
completed/completing trials Desferasirox in
thalassaemia with iron overload Paediatrics
(Novartis) B1744CL trial new inhaler drug in
COPD Respiratory Medicine (Boehringer)
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Clinical Epidemiology Unit
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- Musalmah Mazlan
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Medical Research Industry Secretariat

• Function
• Facilitate research in UKMMC
• Register/Monitor the research in UKMMC
• All researches performed in UKMMC or by UKMMC
  staff
• UKM Human Research and Ethics Committee
• UKM Animal Research and Ethics Committee
• Organize workshops
• Good Clinical Practice (approved)
• Research and methodology
• Statistic/ SPSS
• Art of presentation Podium and Poster

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MRIS REGULAR ACTIVITIES

• Workshops
• SPSS
• Basic
• Advanced
• Good Clinical Practice
• Annual Research Week
• Research Work Retreats Sub-committees
• Defining research guidelines and policies
• Institutional Research Ethics Committee Meeting

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Musalmah Mazlan
Profesor Dr. Ruszymah Hj Idrus Profesor Dr.
Sharifah Noor Akmal Syed Hussain Profesor Dr. Tan
Hock Lim Profesor Dr. S. Fadilah Abd
Wahid Profesor Dr. Cheah Fook Choe Profesor Madya
Dr. Zaitorn Zakaria Profesor Madya (Klinikal)
Dato' Dr. Fuad Ismail Profesor Madya Dr. Ismail
Sagap Profesor Madya Dr. Mohd Rizal Abdul
Manaf Profesor Madya Dr. Saperi Sulung
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IREC Meeting Schedule

• Once a month on average
• Proposals without ethical issues, approved by
  departmental committees (e.g. retrospective
  audits), are approved by chairperson
• All other proposals screened by Chairperson,
  distributed among committee members for scrutiny
  (two weeks), and subsequently dealt with
  according to comments and recommendations by the
  committee member concerned

Chairperson reserves the right to approve
proposals where there are no ethical issues
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Flow Chart for Approval
Protocol Submission
Protocol Screening and Listing (SECRETARIAT
Checklist)
Protocol Distribution Scrutiny by IREC member
2 1 weeks
Letter of Request for Presentation
2 weeks
Protocol Appraisal (IREC)
1 week
Letter of Approval
1 week
1 week
Letter of Request for Amendment
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Animal Ethics Committee

• Chairperson Associate Professor Dr Zaiton
  Zakaria
• Members
• Professor Dr Norhayati Mokhtar (FP, UKM)
• Professor Dr Wan Omar Abdullah (UPM)
• Dr Fuzina Nor Hussein (UPM)
• Dr Naseem Malik (IMR)
• Dr Hawa Ismail (FSKB, UKM)
• Dr Anisah Nordin (FP, UKM)
• Dr Nur Azlina Mohd Fahami (FP, UKM)
• Encik Vivian Jacob Gomes (FP, UKM)
• Encik Low Kiat Cheong (PPSP FP, UKM) - Secretary
• Members are appointed by Deputy Vice Chancellor
  (for 3 years)

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CTW Procedure
Research / Clinical Trial Approved by IREC
Submit / Register protocol with CTW Secretariat

• Study Initiation
• CTW coordinator
• CTW staff nurse
• Investigators and RA
• Relevant consultant /
• specialist involved
• Agree on procedures,
• processes, tests,
• responsibilities,
• charges etc

Plan activities according to Protocol and GCP
standards

• Schedule appointment for subject
• Data generation, collection, documentation
• Registration scheduling of visits
• Blood taking
• Procedures as protocols
• Informed consent

• Discharge
• Administration of trial drug
• Adverse reactions
• Give next appointment

• Laboratory Testing
• Test outside HUKM
• Test inside HUKM

• Study Closure
• CTW lab charges to sponsors or internal grants
• Final report to IREC
• Storage archiving CRF, document data, drugs
  sample
• Submit report when ready

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MOVING FORWARD TOWARDS ESTABLISHING AN EXEMPLARY
AND DEVELOPED CLINICAL TRIAL FACILITY
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Current initiatives planned by Chief of Medical
and Health Technology Niche
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MINISTRY OF HEALTH MALAYSIA CLINICAL TRIALS
SET-UP
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FOREIGN EXEMPLARY MODELS OF CLINICAL TRIAL UNITS
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Thank You
Acknowledgment Some slide format and contents
were modified from the previous contribution
of Prof. Dr. Zaleha Abd Mahdy