Research Pathway in Faculty of Medicine & Clinical Trial Ward
Research Pathway in Faculty of Medicine & Clinical Trial Ward
Research Pathway in Faculty of Medicine & Clinical Trial Ward
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<strong>Research</strong> <strong>Pathway</strong> <strong>in</strong><br />
UKM Medical Centre and<br />
Cl<strong>in</strong>ical <strong>Trial</strong> <strong>Ward</strong><br />
Infrastructure and SOPs<br />
Pr<strong>of</strong> Dr Cheah Fook Choe<br />
Pr<strong>of</strong>essor <strong>of</strong> Paediatrics (Neonatology)<br />
Department <strong>of</strong> Paediatrics<br />
AND<br />
Cl<strong>in</strong>ical <strong>Trial</strong> <strong>Ward</strong> Co-ord<strong>in</strong>ator<br />
UKM Medical Centre
Pusat Pengurusan Penyelidikan & Inovasi<br />
(PPPI)<br />
Centre for <strong>Research</strong> Instrumentation<br />
Management (CRIM)<br />
►Centred <strong>in</strong> UKM Bangi<br />
►Formed <strong>in</strong> January 1995 as "Unit<br />
Pengurusan Penyelidikan" and upgraded to<br />
"Pusat" (PPP) on 1 June 1999, then<br />
renamed PPPI<br />
►Ma<strong>in</strong> function:<br />
Management <strong>of</strong> all research activities<br />
►UKM grants<br />
►External grants
PUSAT PENGURUSAN PENYELIDIKAN & INOVASI (PPPI), UKM<br />
TNC Penyelidikan & Inovasi<br />
Pr<strong>of</strong> Dr Rahmah Mohamed<br />
Pr<strong>of</strong> Dr Che Hassan Che Haron
Tel : 603 8921 3528 / 3096 Fax : 603 8925 4550<br />
Website : http://research.ukm.my<br />
Email : ppupp@ukm.my
PPPI Activities<br />
► Management <strong>of</strong>:<br />
Adm<strong>in</strong>istration and F<strong>in</strong>ances <strong>of</strong> <strong>Research</strong><br />
Conferences (Local & International)<br />
Exhibition <strong>of</strong> <strong>Research</strong> Output<br />
Tra<strong>in</strong><strong>in</strong>g / Workshop / Sem<strong>in</strong>ars on <strong>Research</strong><br />
<strong>Research</strong> Database<br />
<strong>Research</strong> Publicity<br />
Innovation and Technology Transfer<br />
<strong>Research</strong> Instrumentation<br />
Publication <strong>of</strong> Book / Proceed<strong>in</strong>g / Bullet<strong>in</strong> on <strong>Research</strong><br />
Help with Patent Application
List <strong>of</strong> <strong>Research</strong> with Commercial Potential<br />
► 1. Improved Swivel Arm Mechanism<br />
2. Temporal Bone Holder<br />
3. Multimedia <strong>in</strong> Education S<strong>of</strong>tware on Mathematics 4.<br />
Paddy Fluidized Bed Dry<strong>in</strong>g (BERNAS) 5. Chit<strong>in</strong><br />
Chitosan<br />
6. LNR (Liquid Natural Rubber)<br />
7. TPNR (Thermoplastic Natural Rubber) 8.<br />
Cilibangi (Bangi Cilli) 9. Aerobic<br />
Fertiliser<br />
10. Smart Traffic Light System 11.<br />
Fire Pro<strong>of</strong> Key Device<br />
12. Herbal Remopa<strong>in</strong> Film for Ulcer and Wounds<br />
13. Styrylpyrone Derivatives (SPD): The Potential<br />
Therapy for Breast Cancer<br />
14. Anti-diabetic Pharmaceutical Products<br />
15. Tongkat Ali products
<strong>Research</strong> emphasis and focus for UKM status as a<br />
<strong>Research</strong> University
RESEARCH MANAGEMENT - UKM Medical Centre<br />
Centre for <strong>Research</strong> and Innovation<br />
Management<br />
Medical <strong>Research</strong> and<br />
Industry<br />
Secretariat -<br />
Sekretariat Penyelidikan<br />
Perubatan dan Industri<br />
(SPPI)<br />
Pr<strong>of</strong> Musalmah Mazlan<br />
UKM Medical<br />
Molecular<br />
Biology Institute<br />
(UMBI)<br />
Pr<strong>of</strong> Rahman<br />
Jamal<br />
Niche - Health<br />
Technology and<br />
Medic<strong>in</strong>e<br />
\<br />
TKP<br />
UKM Animal<br />
<strong>Research</strong> Ethic<br />
Committee<br />
UKM Human<br />
<strong>Research</strong> Ethic<br />
Committee<br />
Medical<br />
<strong>Research</strong><br />
Committee
UKMMC: Human Resource<br />
► Lecturer 463<br />
Pr<strong>of</strong>essor & Assoc Pr<strong>of</strong> - 136<br />
► PhD holders 43<br />
► 22 departments and 3 research centres<br />
Basic science<br />
Cl<strong>in</strong>ical department<br />
► Teach<strong>in</strong>g Hospital<br />
900 bedded (BOR ~ 60 -70%)<br />
359,365 outpatients<br />
36,181 <strong>in</strong>-patients
Human Resource<br />
Establishment <strong>of</strong> <strong>Research</strong> Centres<br />
►Appo<strong>in</strong>tment as research fellow<br />
Tissue Eng<strong>in</strong>eer<strong>in</strong>g, Case Mix and Adv Surg Skill Centre<br />
Cell therapy centre<br />
►UMBI (<strong>in</strong>dependent <strong>in</strong>stitute)<br />
Dual appo<strong>in</strong>tment at the faculty and research<br />
centre<br />
►Assessment/promotion accord<strong>in</strong>g to the contribution<br />
Time-<strong>of</strong>f to write papers<br />
<strong>Research</strong> collaboration field work
FINANCIAL SUPPORT<br />
► <strong>Research</strong> University<br />
GUP (<strong>Research</strong> University Grant<br />
-start up, promis<strong>in</strong>g research, bridg<strong>in</strong>g, academia<strong>in</strong>dustry<br />
collaboration<br />
OUP (Operational <strong>Research</strong> University)<br />
-post-doctoral and fellowships<br />
PIP (<strong>Research</strong> Instrumentation)<br />
► Fundamental <strong>Research</strong> UKMMC<br />
Up to 750,000 / year<br />
► 20,000/project ~ lecturer/PhD<br />
► 10,000/project ~masters<br />
► 5,000/project ~ undergraduates ►<br />
2,500/project ~ foreign students
Funds management and disbursement - Bendahari/Kewangan UKM Med Centre
FINANCIAL SUPPORT<br />
(External Grant)<br />
► MOSTI (M<strong>in</strong>istry <strong>of</strong> Science, Technology & Innovation)<br />
eScience fund<br />
MOHE - FRGS, ERGS, PRGS, LRGS<br />
Techno-fund/Agri-based<br />
►A committee to screen the proposal before submitt<strong>in</strong>g to<br />
MOSTI/MOHE<br />
► External fund/grant<br />
Pharmaceutical company<br />
NGO's<br />
Industry<br />
Management <strong>of</strong> funds - under Bendahari Bhg<br />
Penyelidikan
<strong>Research</strong> by Department<br />
60<br />
50<br />
40<br />
30<br />
20<br />
10<br />
0
Distribution <strong>of</strong> Type <strong>of</strong> <strong>Research</strong><br />
ANIMAL<br />
METABOLIC<br />
CANCER<br />
CLINICAL<br />
MOLECULAR BIOLOGY<br />
PSYCHIATRY<br />
Pharma-sponsored<br />
stem cell<br />
community<br />
nurs<strong>in</strong>g
Nic - TKP -<br />
7 Kluster dengan kumpulan-kumpulan<br />
Health System and Disease burden<br />
Pr<strong>of</strong> Dr Syed Mohd Aljunid<br />
Family Health<br />
- Pr<strong>of</strong> Dr. Khadijah Samsud<strong>in</strong><br />
Work Health<br />
- Pr<strong>of</strong> Dr. Noor Hassim Ismail<br />
Economic Health<br />
- Pr<strong>of</strong>. Madya Dr. Saperi Sulong
Biomedical eng<strong>in</strong>eer<strong>in</strong>g<br />
Pr<strong>of</strong> Dr. Mohd Alaudd<strong>in</strong> Mohd Ali<br />
Medical devices-<br />
Pr<strong>of</strong>esor Dr. Mohd Alaudd<strong>in</strong> Mohd Ali<br />
Biomechanics and biomaterials -<br />
Pr<strong>of</strong>. Nik Abdullah<br />
Nanobiotechnology
Regenerative Medic<strong>in</strong>e<br />
Pr<strong>of</strong> Dr. Ruszymah Idrus<br />
Tissue eng<strong>in</strong>eer<strong>in</strong>g<br />
-Pr<strong>of</strong> Dr. Ruszymah Idrus<br />
Placental <strong>Research</strong><br />
-Pr<strong>of</strong> Dr Cheah Fook Choe<br />
Cardiovascular and Health<br />
-Pr<strong>of</strong>. Madya Dr. Zaiton Zakaria<br />
Sperm Science<br />
-Dr. Siti Fatimah Ibrahim<br />
Stress enzyme<br />
-Pr<strong>of</strong>. Madya Dr. Farihah Suhaimi
Cancer and Stem Cell<br />
- Pr<strong>of</strong>esor Dr. A Rahman A Jamal<br />
Cancer Biomarker<br />
-Pr<strong>of</strong>esor Dr. A Rahman A Jamal<br />
Breast cancer<br />
-Pr<strong>of</strong>esor Dr. Sharifah Noor Akmal<br />
Biology Stem Cell<br />
-Pr<strong>of</strong>. Madya Dr. Noor Hamidah Huss<strong>in</strong><br />
Stem Cell Technology<br />
-Dr. Shahrul Hisham
Anti-oxidant and metabolisme<br />
Pr<strong>of</strong>esor Dr. Wan Zur<strong>in</strong>ah Wan Ngah<br />
Ag<strong>in</strong>g and degenerative disease<br />
-Pr<strong>of</strong>esor Dr. Wan Zur<strong>in</strong>ah Wan Ngah<br />
Bone metabolism<br />
-Pr<strong>of</strong>esor Dr. Ima Nirwana Soelaiman<br />
Cardiovascular diseases<br />
-Pr<strong>of</strong>esor Dr. Khamsiah Jaar<strong>in</strong><br />
Nutrition and diet<br />
-Pr<strong>of</strong>. Madya Dr. Suzana Shahar<br />
Physical activity and Energy Metabolisme<br />
-Pr<strong>of</strong>. Madya Dr. Poh Bee Koon
Mechanism <strong>of</strong> Illness<br />
-Pr<strong>of</strong>esor Madya Dr. Roslan Harun<br />
Molecular genetics <strong>of</strong> Haematological diseases<br />
- previously, Pr<strong>of</strong>essor Dr. A<strong>in</strong>oon Othman (rtd)<br />
Auditory and Speech Sciences<br />
-Pr<strong>of</strong>. Madya Dr. Siti Zamratol Maisarah Mukari<br />
Helicobacter Pylori<br />
-Pr<strong>of</strong>esor Dr. Ramelah Mohamed<br />
Reproductive Biology<br />
-Dr. Norfilza Mokhtar<br />
Medical Parasitology and Entomology<br />
-Pr<strong>of</strong>esor Dr. Norhayati Isa<br />
Lung diseases<br />
-Pr<strong>of</strong>esor Madya Dr. Roslan Harun
Natural products<br />
-Pr<strong>of</strong>esor Dr. Ibrahim Jantan<br />
►Discovery and delivery <strong>of</strong> medic<strong>in</strong>es<br />
Pr<strong>of</strong>esor Dr. Ibrahim Jantan<br />
►Toxicology<br />
Dr. Noor Fadilah Rejab<br />
►Novel antibiotics<br />
Pr<strong>of</strong>esor Dr. Noraziah Mohamad Z<strong>in</strong>
www.ppukm.ukm.my
Traditionally, UKM Medical <strong>Faculty</strong> <strong>Research</strong> Committee (RC) and Ethics Committee (EC) used<br />
to be two separate committees. The <strong>Research</strong> Committee was responsible for the evaluation <strong>of</strong><br />
research proposals from the po<strong>in</strong>t <strong>of</strong> view <strong>of</strong> scientific merit and methodology as well as for the<br />
approval <strong>of</strong> research grants. The RC also decided whether proposal needed approval<br />
from the EC. The EC on the other hand, evaluated the research proposal from the po<strong>in</strong>t <strong>of</strong><br />
view <strong>of</strong> research ethics to ensure that the rights and safety subjects were protected
INFRASTRUCTURE<br />
►Dedicated research lab<br />
Ma<strong>in</strong>ly at the pre-cl<strong>in</strong>ical<br />
GMP lab (<strong>in</strong> process)<br />
Tissue Eng<strong>in</strong>eer<strong>in</strong>g Lab<br />
Stem Cell Lab<br />
►Service lab<br />
Majority <strong>of</strong> research <br />
Used together with<br />
research<br />
►Collaborative research lab<br />
Inno Bio Sdn Bhd<br />
►Cl<strong>in</strong>ical <strong>Trial</strong> <strong>Ward</strong><br />
►Pharmacy support
CLINICAL TRIAL WARD<br />
► Opened <strong>in</strong> year 2000<br />
► Managed by MRIS<br />
Coord<strong>in</strong>ated by a lecturer<br />
Assisted by 1 Nurse Mgr, 1 KJ, 2 SN, 1 Cl<strong>in</strong>ic Assistant and 1<br />
clerk<br />
► Located on first floor <strong>of</strong> Cl<strong>in</strong>ical Block UKMMC<br />
► Provides assistance to <strong>in</strong>vestigators to run cl<strong>in</strong>ical<br />
trials<br />
Ma<strong>in</strong>ly on healthy/ not ill subjects<br />
► Full facilities for multi-centre drug trials,<br />
<strong>in</strong>clud<strong>in</strong>g bioequivalence studies<br />
► <strong>Ward</strong> facilities<br />
6 beds, wait<strong>in</strong>g areas with TV and video<br />
Consultation room<br />
Storage for drugs and blood specimens, archive room<br />
Emergency resuscitation facilities<br />
Telephone, fax, <strong>in</strong>ternet
<strong>Research</strong> Collaboration<br />
LOCAL<br />
Kementerian Kesihatan Malaysia<br />
Institut Penyelidikan Perubatan (IMR)<br />
IPT la<strong>in</strong>, terutamanya USM, UM<br />
, UPM dan IMU<br />
Syarikat faramsiutikal<br />
National Productivity Centre<br />
Association <strong>of</strong> Private Hospitals <strong>of</strong><br />
Malaysia (APHM)<br />
Malaysian Council for Tobacco Control<br />
Malaysian Public Health Specialists<br />
Association<br />
National Institute <strong>of</strong> Occupational<br />
Safety and Health (NIOSH)<br />
Department <strong>of</strong> Safety and Health<br />
(DOSH<br />
Kementerian Pendidikan Malaysia<br />
Kementerian Pertahanan<br />
Kementerian Sumber Manusia<br />
Kementerian Kesihatan Brunei<br />
Malaysian Palm Oil Board (MPOB)<br />
Pusat Darah Negara<br />
Tai Chi Association Wilayah<br />
Persekutuan<br />
Golden Hope Industries<br />
Malaysian Palm Oil Promotion<br />
Council (MPOPC)<br />
Zoo Negara<br />
Hospital Jabatan Hal Ehwal Orang<br />
Asli<br />
Jabatan Siasatan Jenayah, PDRM<br />
Hospital Mata Tun Husse<strong>in</strong> Onn<br />
Jabatan Imigresen<br />
Jabatan Kebajikan Masyarakat, WP
FOREIGN<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<strong>Research</strong> Collaboration<br />
University <strong>of</strong> New South Wales University<br />
University for Peace, San Jose, Costa Rica<br />
Universiti Gadjah Mada Indonesia<br />
3M Hospital Information System, USA<br />
Wellcome Trust, UK<br />
Syarikat farmasiutikal<br />
Institute <strong>of</strong> Biological <strong>Research</strong>, Barcelona, Sepanyol (Dr. Coral<br />
Sanfeliu)<br />
National Institute <strong>of</strong> Health, Tokyo, Jepun (Dr. Kitagawa)<br />
Department <strong>of</strong> Biochemistry, University <strong>of</strong> Western<br />
Australia, Perth (Pr<strong>of</strong>essor Dr. George Yeoh)<br />
Japanese National Institute <strong>of</strong> Infectious Diseases, Tokyo<br />
Hamamatsu University, School <strong>of</strong> Medic<strong>in</strong>e, Japan<br />
Centre fo Gene Analysis & Technology (CGAT)
FOREIGN<br />
<strong>Research</strong> Collaboration<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
University <strong>of</strong> Queensland Bra<strong>in</strong> Centre,<br />
National Neuroscience Institute <strong>of</strong> S<strong>in</strong>gapore<br />
University <strong>of</strong> Melbourne<br />
University <strong>of</strong> Dundee Medical Education Centre<br />
University <strong>of</strong> Queensland Dentritic Cell Centre<br />
Mater Medical <strong>Research</strong> Institute, Queensland, Australia<br />
Southeast Asia Alliance for Tobacco Control<br />
Rockefeller Foundation<br />
World Health Organisation (WHO)<br />
International Labour Office (ILO)<br />
World Bank<br />
London School <strong>of</strong> Hygiene and Tropical Medic<strong>in</strong>e<br />
Asia Pacific Academic Consortium for Public Health<br />
(APACPH)
Recent Collaboration<br />
<strong>Research</strong> collaboration through MoU /<br />
MoA<br />
► ANZ Burns Association<br />
► Newcastle University,<br />
Australia<br />
► Australia Advanced<br />
School <strong>of</strong> Medic<strong>in</strong>e<br />
► Great Ormond Street<br />
Hospital, United K<strong>in</strong>gdom<br />
Inno Bio Sdn Bhd<br />
Pr<strong>in</strong>ce Court Hospital<br />
Institute Jantung Negara<br />
UNU-IIGH
E.g. Cl<strong>in</strong>ical <strong>Trial</strong>s <strong>in</strong> progress<br />
Rivarox study - rivaroxaban <strong>in</strong> acute coronary syndrome - Cardiology<br />
(J&J)<br />
Aspire trial - Aripiprazole <strong>in</strong> schizophrenia - Psychiatry (Otsuka)<br />
LUX-Lung 3 - Phase 3 trial Rx for lung adenoCa - Oncology (Boehr<strong>in</strong>ger)<br />
BASILEA WSA-CS-008 - New drug vs casp<strong>of</strong>ung<strong>in</strong> f/b voriconazole <strong>in</strong> Rx<br />
candidemia - Haematology (Basilea Pharma)<br />
E.g. Recently completed/complet<strong>in</strong>g trials<br />
Desferasirox <strong>in</strong> thalassaemia with iron overload - Paediatrics (Novartis)<br />
B1744CL trial - new <strong>in</strong>haler drug <strong>in</strong> COPD - Respiratory Medic<strong>in</strong>e<br />
(Boehr<strong>in</strong>ger)
Medical <strong>Research</strong> and Industry Secretariat<br />
Assistant Registrar (N41)<br />
Science Officer (C41)<br />
Secretary (N27)<br />
3 Officer (N17)<br />
1 <strong>of</strong>ficer (N1)<br />
Industrial<br />
Collaboration<br />
Cl<strong>in</strong>ical <strong>Trial</strong><br />
<strong>Ward</strong><br />
Publication<br />
<strong>Research</strong><br />
Centre<br />
Cl<strong>in</strong>ical Epidemiology Unit<br />
Journal Publications<br />
Medic<strong>in</strong>e and Health<br />
Surgical Academia<br />
1. Tissue eng<strong>in</strong>eer<strong>in</strong>g<br />
2. Case Mix centre<br />
3. Adv Surg SC<br />
4. Cell therapy
- Musalmah Mazlan
Medical <strong>Research</strong> & Industry<br />
Secretariat<br />
► Function<br />
Facilitate research <strong>in</strong> UKMMC<br />
Register/Monitor the research <strong>in</strong> UKMMC<br />
► All researches performed <strong>in</strong> UKMMC or by UKMMC<br />
staff<br />
UKM Human <strong>Research</strong> and Ethics Committee<br />
UKM Animal <strong>Research</strong> and Ethics Committee<br />
Organize workshops<br />
► Good Cl<strong>in</strong>ical Practice (approved)<br />
► <strong>Research</strong> and methodology<br />
► Statistic/ SPSS<br />
► Art <strong>of</strong> presentation - Podium and Poster
MRIS: REGULAR ACTIVITIES<br />
► Workshops<br />
SPSS<br />
► Basic<br />
► Advanced<br />
Good Cl<strong>in</strong>ical Practice<br />
► Annual <strong>Research</strong> Week<br />
► <strong>Research</strong> Work Retreats & Sub-committees<br />
Def<strong>in</strong><strong>in</strong>g research guidel<strong>in</strong>es and policies<br />
► Institutional <strong>Research</strong> & Ethics Committee Meet<strong>in</strong>g
Musalmah Mazlan<br />
Pr<strong>of</strong>esor Dr. Ruszymah Hj Idrus<br />
Pr<strong>of</strong>esor Dr. Sharifah Noor Akmal Syed Hussa<strong>in</strong><br />
Pr<strong>of</strong>esor Dr. Tan Hock Lim<br />
Pr<strong>of</strong>esor Dr. S. Fadilah Abd Wahid<br />
Pr<strong>of</strong>esor Dr. Cheah Fook Choe<br />
Pr<strong>of</strong>esor Madya Dr. Zaitorn Zakaria<br />
Pr<strong>of</strong>esor Madya (Kl<strong>in</strong>ikal) Dato' Dr. Fuad Ismail<br />
Pr<strong>of</strong>esor Madya Dr. Ismail Sagap<br />
Pr<strong>of</strong>esor Madya Dr. Mohd Rizal Abdul Manaf<br />
Pr<strong>of</strong>esor Madya Dr. Saperi Sulung
Jawatankuasa Etika Penyelidikan PPUKM<br />
Pengerusi<br />
Pr<strong>of</strong>esor Madya (K) Dato' Dr. Fuad Ismail<br />
Ahli Jawatankuasa<br />
(Ahli Tetap)<br />
Ahli Jawatankuasa<br />
(Ahli Ganti)<br />
Pr<strong>of</strong>esor Dr Musalmah Mazlan<br />
Pr<strong>of</strong>esor Dr. Rohaizak Muhammad<br />
Pr<strong>of</strong>esor Dr. A Rahman A Jamal<br />
Pr<strong>of</strong>esor Dato' Dr. Syed Mohamed Al- Junid<br />
Pr<strong>of</strong>esor Dr. Wan Zur<strong>in</strong>ah Wan Ngah<br />
Pr<strong>of</strong>esor Dr. Ima Nirwana Soelaiman<br />
Pr<strong>of</strong>esor Dr. Baharud<strong>in</strong> Hj. Omar<br />
Pr<strong>of</strong>esor Dr. Zaleha Abdullah Mahdy<br />
Pr<strong>of</strong>esor Dr. Nor Azmi Kamarudd<strong>in</strong><br />
Pr<strong>of</strong>esor Dr. Syed Zulkifli Syed Zakaria<br />
Pr<strong>of</strong>esor Madya Dr Mohd Cairul Iqbal Mohd Am<strong>in</strong><br />
Pr<strong>of</strong>esor Madya Dr Rizal Abdul Manaf<br />
Pr<strong>of</strong>esor Madya (K) Dr Oteh Maskon<br />
Pr<strong>of</strong>esor Madya Dr. Ibrahim Abu Bakar<br />
Pr<strong>of</strong>esor Madya Dr. Roszal<strong>in</strong>a Ramli<br />
Pr<strong>of</strong>esor Madya Dr. Ismail Sagap<br />
Pn Hendon Mohamed<br />
En Tan Meng Leng<br />
Pr<strong>of</strong>esor Dr Jamal Hisham Hashim<br />
Pr<strong>of</strong>esor Madya Dr Roslan Harun<br />
Pr<strong>of</strong> Madya (K) Dr Fuad Ismail<br />
Pr<strong>of</strong> Madya (K) Dr Nor Azl<strong>in</strong> B<strong>in</strong>ti Mohamed Ismail<br />
Pr<strong>of</strong> Madya Dr Noraidah Masir<br />
Pr<strong>of</strong>. Dr. Ya Mohammad Hassan Shukur<br />
Pr<strong>of</strong> Madya Dr Zar<strong>in</strong>a Abdul Latiff<br />
Pr<strong>of</strong>. Madya Dr. Norazl<strong>in</strong>a Mohamed<br />
Pr<strong>of</strong>esor Madya Dr Kart<strong>in</strong>i Ahmad<br />
Dr Mohd Makmor Bakry<br />
Dr Rohaya Megat Abd Wahab
IREC Meet<strong>in</strong>g Schedule<br />
► Once a month on average<br />
► Proposals without ethical issues, approved by<br />
departmental committees (e.g. retrospective<br />
audits), are approved by chairperson*<br />
► All other proposals screened by Chairperson,<br />
distributed among committee members for<br />
scrut<strong>in</strong>y (two weeks), and subsequently dealt with<br />
accord<strong>in</strong>g to comments and recommendations by<br />
the committee member concerned<br />
*Chairperson reserves the right to approve proposals where there are no ethical issues
Flow Chart for Approval<br />
Protocol Submission<br />
Protocol Screen<strong>in</strong>g and List<strong>in</strong>g (SECRETARIAT Checklist)<br />
Protocol Distribution & Scrut<strong>in</strong>y by IREC member<br />
2 + 1 weeks<br />
Letter <strong>of</strong> Request for Presentation<br />
1 week<br />
Letter <strong>of</strong> Approval<br />
2 weeks<br />
Protocol Appraisal (IREC)<br />
1 week 1 week<br />
Letter <strong>of</strong> Request for Amendment
Animal Ethics Committee<br />
► Chairperson: Associate Pr<strong>of</strong>essor Dr Zaiton Zakaria<br />
► Members:<br />
Pr<strong>of</strong>essor Dr Norhayati Mokhtar (FP, UKM)<br />
Pr<strong>of</strong>essor Dr Wan Omar Abdullah (UPM)<br />
Dr Fuz<strong>in</strong>a Nor Husse<strong>in</strong> (UPM)<br />
Dr Naseem Malik (IMR)<br />
Dr Hawa Ismail (FSKB, UKM)<br />
Dr Anisah Nord<strong>in</strong> (FP, UKM)<br />
Dr Nur Azl<strong>in</strong>a Mohd Fahami (FP, UKM)<br />
Encik Vivian Jacob Gomes (FP, UKM)<br />
Encik Low Kiat Cheong (PPSP FP, UKM) - Secretary<br />
Members are appo<strong>in</strong>ted by Deputy Vice Chancellor (for 3 years)
CTW Procedure<br />
<strong>Research</strong> / Cl<strong>in</strong>ical <strong>Trial</strong><br />
Approved by IREC<br />
Submit / Register protocol<br />
with CTW Secretariat<br />
Plan activities accord<strong>in</strong>g to<br />
Protocol and GCP standards<br />
Study Initiation<br />
•CTW coord<strong>in</strong>ator &<br />
CTW staff nurse<br />
•Investigators and RA<br />
•Relevant consultant /<br />
specialist <strong>in</strong>volved<br />
•Agree on procedures,<br />
processes, tests,<br />
responsibilities,<br />
charges etc<br />
Schedule appo<strong>in</strong>tment for subject<br />
•Data generation, collection, documentation<br />
•Registration & schedul<strong>in</strong>g <strong>of</strong> visits<br />
•Blood tak<strong>in</strong>g<br />
•Procedures as protocols<br />
•Informed consent<br />
Laboratory Test<strong>in</strong>g<br />
•Test outside HUKM<br />
•Test <strong>in</strong>side HUKM<br />
Discharge<br />
•Adm<strong>in</strong>istration <strong>of</strong> trial drug<br />
•Adverse reactions<br />
•Give next appo<strong>in</strong>tment<br />
Study Closure<br />
•CTW & lab charges to sponsors or <strong>in</strong>ternal grants<br />
•F<strong>in</strong>al report to IREC<br />
•Storage & archiv<strong>in</strong>g - CRF, document data, drugs s<strong>amp</strong>le<br />
•Submit report when ready
MOVING FORWARD TOWARDS<br />
ESTABLISHING AN EXEMPLARY<br />
AND DEVELOPED<br />
CLINICAL TRIAL FACILITY
Current <strong>in</strong>itiatives planned by Chief <strong>of</strong> Medical and Health Technology Niche
MINISTRY OF HEALTH MALAYSIA - CLINICAL TRIALS SET-UP
FOREIGN EXEMPLARY MODELS OF CLINICAL TRIAL UNITS
Acknowledgment:<br />
Some slide format and contents<br />
were modified from the<br />
previous contribution <strong>of</strong><br />
Pr<strong>of</strong>. Dr. Zaleha Abd Mahdy
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