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Clinical Research Centre
Hospital Tuanku Fauziah
Unit Profile
Vision & mission
Vision
To become the leading clinical research
institution in northern region of peninsular
Malaysia.
Mission
To improve patients’ health outcome
through ethical and quality clinical research.
Establishment
Clinical Research Centre Hospital Tuanku
Fauziah, Kangar, Perlis (CRC HTF) was
established on May 7th, 2007.
Its main function is to establish conducive
environment to enable ethical and quality
clinical research projects to be carried out for
the improvements of patients’ health
outcome.
Head of Unit
2007
Dr Sia Soon Keat
Department of Internal Medicine
2008-2009
Dr Zalwani Zainuddin
Department of Internal Medicine
2009-2013
Dr Yeap Ewe Juan
Department of Orthopaedics
2014-2016
Dr Noram Azlan Ramli
Department of Ophthalmology
2017-2019
Dr Nizar Bidin
Department of O&G
2020
Dr Khairul Shakir Ab Rahman
Department of Pathology
2021-2023
Dr Ruzita Jamaluddin
Department of Psychiatry and Mental Health
LEVEL 1, “BLOK KLINIK PAKAR” (NEXT TO “DEWAN INSANIAH”)
Source: htf.moh.gov.my
ORGANIZATION CHART
CRC HTF STAFF
Dr Ruzita Jamaluddin
Head
Consultant Psychiatrist UD56
2021
Ms Siti Ertina Asli
CRM Study Coordinator
2009
SN Siti Zulaiha Che Hat
Staff nurse U29
2018
Ms Nor Efarina Abdul
Rahman
Administrative assistant N19
2010
Mr Rohaizan Isa
Operational assistant N11
2010
Dr Irma Liyana Mushaddik
Deputy
Medical officer UD52
2021
Mr Ang Wei Chern
Admin manager
Pharmacist UF48
2016
Dr Amalina Anuar
Medical officer UD48
2018
Dr Noor Suhaiza Morat
Medical officer UD52
2023
CRC COMMITTEE MEMBERS :
APPOINTMENT DATE 2022 - 2023
HOSPITAL RESEARCH REVIEW COMMITTEE :
APPOINTMENT DATE 2022-2023
PERFORMANCE INDICATOR FOR
CRC HTF
1. Number of NMRR registered IIR (Investigator Initiated Research)
2. Number of research collaboration with IPTA/IPTS
3. Number of publications :
• Number of publications by CRC staffs
• Types of published articles
• Publication in high indexed journal
4. Number of ISR (Industrial Sponsored Research)
5. Research Consultations
6. CRC research training activities
7. CRC staffs achievements
NMRR - REGISTRED IIR 2018 -2023
3 2
11
1
2
2 4
4
1
45
38
47
51
55
15
2018 2019 2020 2021 2022 2023
JKN PKD HTF
Updated 1 April 2023
No. NMRR ID Project Full Title Principal Investigator
1 NMRR ID-23-00175-ULY
Knowledge, Attitude and Practice on Preparation and Administration of
Intravenous Medications among Nurses in Hospital Tuanku Fauziah, Perlis
SITI ZULAIHA BINTI CHE
HAT
2 NMRR ID-23-00211-TFX
COVID-19 and Climate Change: Prospects for a ‘Green’ Recovery in the
Indian Ocean Region SEE MING SHE
3 NMRR ID-23-00225-FMQ
KNOWLEDGE AND ATTITUDE ABOUT ACUTE DELIRIUM IN THE
ELDERLY AMONG EMERGENCY DEPARTMENT DOCTORS IN
MALAYSIAN GOVERNMENT HOSPITALS Mohd Johar Bin Jaafar
4 NMRR ID-23-00227-QKT
Quality of Work-Life, Burnout and Professional Commitment among Nurses: A
Multicentre Analysis Government and Private Hospitals in Malaysia VALERMATHIE A/P VELLU
5 NMRR ID-23-00239-RCQ
Patient Profile and Mental Health Issues Among New Cases Referred To The
Hospital Tuanku Fauziah Psychiatric Team Before, During And After The
COVID-19 Pandemic: A 4-Year Retrospective Analysis Ruzita binti Jamaluddin
6 NMRR ID-23-00292-PWX
The Local Needs and Gaps in Pharmacogenomics Knowledge and Education
Among Healthcare Professionals in Malaysia: A Delphi Study
Safa Hassan Mohamed
Hassan Omran
7 NMRR ID-23-00295-9N5
Ketogenic diet in women with polycystic ovarian syndrome (PCOS): a
systematic review and meta-analysis of clinical trials KARNIZA BT KHALID
8 NMRR ID-23-00407-YMC Perception of Pain among Surgical Ward Patients: A Cross-Sectional Study Jason Wong Soon Keong
9 NMRR ID-23-00604-FWH
The Journey to Embryonal Rhabdomyosarcoma (FNCLCC Grade 2) detection:
A Case Report
NIK NUR
FARAHIYAH@HIDAYAH
BINTI NIK ZAINAL ABIDIN
10 NMRR ID-23-00746-2DH
Shoulder dystocia: a review on incidence, maternal and perinatal risk factors
and outcome Nur Farihan binti Mukhtar
11 NMRR ID-23-00756-KIH
Faktor-Faktor yang Mempengaruhi Niat Penggunaan ICD-11 Dalam Kalangan
Pegawai Tadbir Rekod Perubatan dan Penolong Pegawai Tadbir Rekod
Perubatan di Fasiliti KKM Zaleha binti Md. Isa
12 NMRR ID-23-00957-FDQ
AN ONLINE SURVEY OF AUDIOLOGIST’S AWARENESS AND PRACTICE
OF AUDITORY PROCESSING IN MINISTRY OF HEALTH MALAYSIA MERLINDA W BERNARD
13 NMRR ID-23-01061-EM1 AUDIT ON READMISSION RATE OF UNSTABLE ANGINA CHUAH SEAN JYI
14 NMRR ID-23-01062-XDU
Factors contributing to HPV vaccine hesitancy among adolescents and the
recommended interventions: A review of quality improvement methodologies KARNIZA BT KHALID
15 NMRR ID-23-00538-T23
Cardiology Clinic Hospital Tuanku Fauziah Clinical Audit 2022: Adherence to
ACEi/ARB in STEMI Patients Admitted to CCU HTF between January and
June 2022 Khairul Azhar Bin Abu Bakar
NMRR - REGISTRED IIR HTF, 2023
No
.
NMRR ID Project Full Title Principal Investigator
1
NMRR ID-23-00410-
75L
IDENTIFYING PREVENTABLE FACTORS FOR
EARLY CASE DETECTION AND TREATMENT
ADHERENCE IN LEPROSY
Rafidah Binti Ali, MOHD
FIRDAUS BIN RAZALI
NMRR- REGISTRED IIR JKN PERLIS, 2023
No
.
NMRR ID Project Full Title Principal Investigator
1
NMRR ID-23-00587-
ZAA
Depression, Anxiety and Stress Among Pregnant
Women in Perlis: A Cross Sectional Survey
SITTI FATIMAH BINTI
AJUI (KK Kangar, KK
Beseri)
NMRR- REGISTRED IIR PKD 2023
10
13
14
13
10
0
2
4
6
8
10
12
14
16
2019 2020 2021 2022 2023
No.
Year
Minimum 10 collaboration with IPTA/S in a year
Updated 1 May 2023
RESEARCH COLLABORATION WITH IPTA/IPTS 2019-2023
RESEARCH COLLABORATION WITH IPTA/IPTS 2023
No Research Title Main researcher at site Collaboration Institution Current status
1 Health Utility and Health-related Quality of Life of
HIV Patients in a Malaysian State Hospital
Ang Wei Chern
(CRC HTF)
Universiti Sains Malaysia Write-up
(NMRR-21-1549-60908)
2 Prevalens dan Faktor-faktor yang Berkaitan Dengan
Anemia Semasa Kehamilan: Sebuah Kajian
Kuantitatif Dalam Kalangan Ibu Hamil Di Klinik
Kesihatan Di Negeri Perlis
Dr. Amalina Anuar
(CRC HTF)
Open University Malaysia
(OUM)
Report Writing
(NMRR-22-02473-3DR)
3 RESOLVE-Randomised Evaluation of Sodium
Dialysate Levels on Vascular Events
Dr Wan Syamir Zharif bin
Wan Ahmad Kammal
(Nephro HTF)
University of Sydney New site in HTF
(NMRR-19-3823-52045)
4 Snakebite: Evaluation of Knowledge among Farmers
in the State of Perlis
Ang Wei Chern
(CRC HTF)
Universiti Kebangsaan
Malaysia (UKM)
Data collection (NMRR-
21-1797-61372)
5 Experience of preceptors on Provisional Registered
Pharmacist (PRP) training programme in the state of
Perlis, Malaysia: a qualitative study.
Ang Wei Chern
(CRC HTF)
Universiti Kebangsaan
Malaysia (UKM)
Data collection (NMRR
ID-22-02283-YCO)
6 Budget Impact Analysis of Ferric Derisomaltose for
the Treatment of Iron-Deficiency in Malaysia
Ang Wei Chern
(CRC HTF)
Monash University Malaysia Pending publication in
MJMHS
7 Factors affecting choice of post graduate training
pathway in internal medicine in Malaysia
Datuk Seri Dr Paras Doshi
(Medical HTF)
University of Cambridge Protocol writing and
NMRR registration
8 Breast cancer status, grading system, etiology, and
challenges in Asia: an updated review
Dr Khairul Shakir Ab Rahman
(Pathology HTF)
Universiti Malaysia Perlis
(UniMaP)
Published in 2023
https://doi.org/10.1515/
oncologie-2022-1011
9 Morphological features-oriented fusion extraction
method for quantification of tubules and non-tubules
in breast carcinoma
Dr Khairul Shakir Ab Rahman
(Pathology HTF)
Universiti Malaysia Perlis
(UniMaP)
Applying FRGS grant
and NMRR
10 A novel formulation of automated tumor volume
detection and characterization method using fusion
feature extraction
Dr Wan Irnawati Wan Ab
Rahman (Radiology HTF)
Universiti Malaysia Perlis
(UniMaP)
Applying FRGS grant
and NMRR
MSQH Std 26.5.1.6b
Bilangan penerbitan: Minimum 2 setahun (sebagai denominator)
Updated 1 May 2023
PUBLICATION ACHIEVEMENT 2018-2023
CRC STAFFS ACHIEVEMENTS IN
PUBLICATIONS 2021-2023
14 17
5
10
17
10
0
5
10
15
20
25
30
35
40
2021 2022 2023
CRC non-CRC
24
34
15
TYPES OF PUBLISHED ARTICLES 2021-2013
16
24
10
6 6
3
2
4
2
0
5
10
15
20
25
30
2021 2022 2023
Original article case report review article
PUBLICATIONS IN HIGH INDEXED
JOURNALS 2021-2023
*High indexed journal : Web of
Science (SCI or SCIE) / Scopus
11
17
8
13
17
7
0
2
4
6
8
10
12
14
16
18
2021 2022 2023
high indexed journal non high indexed journal
No Author Title Journal High index
journal
IF SJR
1 First author:
Dr Nur Farihan
Mukhtar
(O&G, HTF)
Paracetamol as analgesia
following Spontaneous
Vaginal Delivery:
Reappraisal of Practice
The Malaysian Journal
of Nursing
- - -
2 First author:
Ruzita Jamaluddin
(Psychiatry & CRC,
HTF)
Lithium toxicity in a
patient with bipolar
disorder: Lesson learned
Current Psychiatry Scopus
(Q4)
- 0.14
3 Co-author:
Dr Khairul Shakir Ab
Rahman
(Pathology
Department , HTF)
Pap Smear Images
Classification Using
Machine Learning:
A Literature Matrix
Diagnostics WoS (SCIE)
Scopus
(Q2)
3.992 0.66
4 Co-author
Dr Khairul Shakir Ab
Rahman
(Pathology
Department, HTF)
Artificial Intelligence
(AI) in Breast Imaging:
A Scientometric
Umbrella Review
Diagnostics WoS (SCIE)
Scopus
(Q2)
3.992 0.66
Publications from HTF 2023
No Author Title Journal High index
journal
IF SJR
5 First author:
SN Siti Zulaiha Che Hat
(CRC, HTF)
Mental Health Burden from
COVID-19: Findings from
a Single Hybrid Hospital in
Northwest Malaysia
Malaysian Journal of
Medicine and Health
Sciences
Scopus
(Q4)
- 0.14
6 Co author:
Ang Wei Chern
(CRC, HTF)
Exploration of hybrid deep
learning algorithms for
covid-19 mRNA vaccine
degradation prediction
system
International Journal of
Advances in Intelligent
Informatics
Scopus
(Q3)
- 0.39
7 First author
Dr Syuhaida Shuib
(Emergency
Department, HTF)
Holistic Approach to
Ecstasy-induced Atrial
Fibrillation in a Young
Patient: A Case Report
Malaysian Journal of
Medical Research
- - -
8 Co-author
Dr Khairul Shakir Ab
Rahman
(Pathology Department ,
HTF)
Fuzzy Relevant Regions
Segmentation in Breast
Histopathology Images
using FCM
2022 IEEE International
conference on Automatic
Control and Intelligent
Systems (12CACIS)
- - -
No Author Title Journal High index
journal
IF SJR
9 Co-author
Dr Khairul Shakir Ab
Rahman
(Pathology Department ,
HTF)
A Non-Mitosis Reduction
Method using Semantic
Descriptors for Breast
Cancer Mitosis Detection
Application
2022 IEEE International
conference on Automatic
Control and Intelligent
Systems (12CACIS)
- - -
10 Co-author:
Dr Khairul Shakir Ab
Rahman
(Pathology Department ,
HTF)
Nuclei Segmentation in
Breast Histopathology
Images using FCM
2022 IEEE International
conference on Automatic
Control and Intelligent
Systems (12CACIS)
- - -
11 Co-author:
Dr Nur Diana Mastura
Zulkifli
(Pathology Department ,
HTF)
Smart Management
Waiting System for
Outpatient Clinic
Journal of Advanced
Research in Applied
Sciences and Engineering
Technology
- - -
12 Co author
Dr Khairul Shakir Ab
Rahman
(Pathology Department ,
HTF)
Breast cancer status,
grading system, etiology,
and challenges in Asia: an
updated review
Oncologie Journal Scopus
(Q4)
- 0.14
No Author Title Journal High index
journal
IF SJR
13 Co-author
Dr Muhammad
Ridwan Yeop Ismail
(OMF, HTF)
Perception Regarding
the NICE Guideline on
Antibiotic Prophylaxis
against Infective
Endocarditis Following
Dental Procedures: A
Cross-Sectional Study
MDPI antibiotics WoS (SCIE)
Scopus
(Q1)
5.22 0.97
14 First author:
Ang Wei Chern
(CRC, HTF)
Inequalities in
Consumption
Expenditure on
Pharmaceuticals:
Evidence from Malaysia
International Journal of
Social Determinants of
Health and Health
Services
WoS (SCIE) 1.851 -
15 First author:
Irma Liyana Mushaddik
(CRC, HTF)
The rare case of
synchronous multiple
primary malignancies of
invasive ductal
carcinoma and diffuse
large B-cell lymphoma
in a single patient: A
diagnostic conundrum
Medical Journal of
Malaysia Case Reports
- - -
Publication Award 2022
Psychiatry
Department
received
Outstanding
Publication
Award 2022
3 3
2
5
2
0
1
2
3
4
5
6
2019 2020 2021 2022 2023
No.
Year
Updated 1 May 2023
Industrial Sponsored Research (ISR)
Involvement 2019-2023
ISR
Principal
investigator Site Department Title of study Sponsor
Year
activated
Year
completed
Dr Ruzita
binti
Jamaluddin HTF Psychiatry
Confirmatory Study of DSP-5423P in Patients with
Schizophrenia (Phase 3)
Sumitomo
Dainippon 2017 2018
Dr Siti Akma
binti Ishak HTF Paediatrics
A Randomized, Multicenter, Double-Blind, Parallel-Group,
Placebo-Controlled Study to Investigate the Efficacy and
Safety of Canagliflozin in Children and Adolescents (>=10
to <18 years) with Type 2 Diabetes Mellitus Janssen 2018 Ongoing
Dr Siti Akma
binti Ishak HTF Paediatrics
A Phase III, Randomized, Observer-bind, Multicenter
Study to Evaluate the Efficacy, Immunogenicity and
Safety of Seqirus’ Cell-Based Quadrivalent Subunit
Influenza Virus Vaccine (QIVc) Compared to a Non-
Influenza Vaccine when Administered in Healthy Subjects
aged 6 months through 47 Months Seqirus 2019 2020
Dr Siti Akma
binti Ishak HTF Paediatrics
A Phase 2, Double-blind, Placebo-controlled Study to
Evaluate the Antiviral Activity, Clinical Outcomes, Safety,
Tolerability, and Pharmacokinetic/Pharmacodynamic
Relationships of Different Doses of JNJ-53718678 in
Children >28 Days and <3 Years of Age With Acute
Respiratory Tract Infection Due to Respiratory Syncytial
Virus Infection Janssen 2019 2022
Dr Suhaila
binti Ab
Wahab HTF
Internal
Medicine
A Phase 2b, Randomized, Double-Blind, Placebo-
Controlled Study of EDP-938 Administered Orally for the
Treatment of Acute Upper Respiratory Tract Infection with
Respiratory Syncytial Virus in Ambulatory Adult Subjects
(RSVP)
Enanta
Pharmaceutical
s -
2022
(Premature
closure)
Dr Suhaila
binti Ab
Wahab HTF
Internal
Medicine
A Randomized, Placebo-Controlled, Phase III Study to
Evaluate the Efficacy and Safety of Proxalutamide
(GT0918) in Hospitalized COVID-19 Subjects
Kintor
Pharmaceutical
s 2022 2022
Dr Noorhafini
binti Abdul
Sukur HTF
Internal
Medicine
Randomised, double-blind, placebo-controlled and
parallel dose group trial to investigate efficacy and safety
of multiple doses of oral BI 690517 over 14 weeks, alone
and in combination with empagliflozin, in patients with
diabetic and non-diabetic chronic kidney disease
Boehringer
Ingelheim 2022 Ongoing
List of ISR in Perlis
NO TITLE OF STUDY PI TARGET ACHIEVED STATUS
1 A Randomized, Multicenter,
Double-Blind, Parallel-
Group, Placebo-Controlled
Study to Investigate the
Efficacy and Safety of
Canagliflozin in Children
and Adolescents (>=10 to
<18 years) with Type 2
Diabetes Mellitus
Dr Siti Akma
binti Ishak
2 2 2 subjects
completed the
study visit.
Awaiting for
Close out visit
2 Randomised, double-blind,
placebo-controlled and
parallel dose group trial to
investigate efficacy and
safety of multiple doses of
oral BI 690517 over 14
weeks, alone and in
combination with
empagliflozin, in patients
with diabetic and non-
diabetic chronic kidney
disease
Dr Noorhafini
binti Abdul
Sukur
2 1 ongoing
ONGOING ISR IN HTF : CURRENT STATUS
4 4
5
4
5
3
0
1
2
3
4
5
6
2018 2019 2020 2021 2022 2023
No.
Year
CRC RESEARCH TRAINING ACTIVITIES
2018-2023
MSQH Std 26.5.1.6a
Bilangan latihan dianjurkan: Minimum 2 setahun (sebagai denominator)
Updated 5 May 2023
No. Event / Workshop / Course Date Venue
1. Good Clinical Practice (GCP) Workshop 07/03/2023 (Tuesday) - 09/03/2023
(Thursday)
Online & Putra Regency, Perlis /
Hotel Seri Malaysia, Perlis
2. Introduction to Clinical Research (ICR) 13/03/2023 (Monday) - 14/03/2023
(Tuesday)
Online - zoom
3. Protocol Writing & NMRR Registration
Workshop
16/03/2023 (Thursday) - 17/03/2023
(Friday)
Bilik Gerakan, JKN
4. Basic Biostatistics Workshop 07/06/2023 (Wednesday) - 08/06/2023
(Thursday)
Dewan MRI, HTF/ Bilik Gerakan, JKN
5. Publication Retreat Workshop 14/06/2022 (Wednesday) - 16/06/2023
(Friday)
Bilik Gerakan, JKN
6. Hari Kualiti & Penyelidikan 2023 26 – 27 October 2023 JKN Perlis
7. Research Consultation Clinic (RCC) Appointment basis CRC Office, HTF
CRC RESEARCH TRAINING ACTIVITIES 2023
Good Clinical Practice 2023 on
7th – 9th March 2023
Introduction to Clinical Research 2023 on
13th -14th March 2023
Protocol Development & NMRR Registration 2023
on 16th – 17th March 2023
ACHIEVEMENTS
Snippet from CRM bulletin Issue 12
STAR Recruiter Award for BRILLIANT Study
Principal investigator: Dr Ruzita Jamaluddin
Department of Psychiatry and Mental Health
HTF
Snippet from
CRM bulletin Issue
20
Rising Stars in Paediatrics
Dr Siti Akma Ishak
Department of Paediatrics
HTF
Awards Recipient
MR ANG WEI CHERN
CRC ADMIN MANAGER / PHARMACIST
2021 1 Best Oral Presentation
3rd World Congress on Integration & Islamicization (IMAM)
2021
2 Outstanding Poster Award
National Pharmacists Convention 2021
3 Young Investigator Award (Clinical)
National Institute of Health (NIH)
2022 1 2nd place oral presentation
23rd Islamic Medical Association of Malaysia (IMAM)
2 2nd runner up poster presentation
15th National Conference for Clinical Research (NCCR)
2nd place oral presentation
23rd Islamic Medical
Association of Malaysia
(IMAM)
Annual Scientific Conference
8-9 Oct 2022
2nd runner up
poster presentation
15th National Conference
for Clinical Research
(NCCR)
18-20 Oct 2022
Awards Recipient
DR KARNIZA BINTI KHALID
DEPUTY HEAD / MEDICAL OFFICER UD 52
2021 1 Best Oral Presentation
9th International Conference on Biological & Medical
Sciences, Suzhou, China (ICBMS 2021) [Virtual meeting]
2022 1 3rd place Oral Presentation – RCSI & UCD Medical College
(RUMC) Research Day 2022 [Virtual meeting]
2 2nd place ePoster Presentation
26th Malaysian Society of Paediatric Haematology and
Oncology (MASPHO) Annual Scientific Meeting
[Virtual meeting]
RCSI & UCD (RUMC)
Research Day 2022
CRC HTF was ranked 1st
for no. of ongoing
research on COVID-19
among all CRC network
in Malaysia (Jan-Jun
2021)
Source: CRC Network Meeting 02-Sep-2021
CRC HTF was ranked 2nd
for no. of publications
among all CRC network
in Malaysia in Jan-Jun
2021
Source: CRC Network Meeting 02-Sep-2021
Contributions from CRC staff
Dr Ruzita Jamaluddin Head of Unit 1. Panel Jawatankuasa Etika Penyelidikan Manusia UniMAP
2021-Current
2. Industry panel for AHIBS Action Research Challenge
2021
Dr Karniza Khalid Deputy /
Medical
officer UD52
1. Panel Jawatankuasa Etika Penyelidikan Manusia UniMAP
2021-Current
2. Panel for state level QA projects presentation (JKN
Perlis) 2022
3. Industry panel for AHIBS Action Research Challenge
2021
4. Elected as expert panel for Projek Kajian Awal Dasar
Perpaduan Negeri Selangor by Institut Kajian Etnik UKM
Bangi 2021
Mr Ang Wei Chern Admin
manager /
Pharmacist
1. Jury for Research and Innovation Exhibition UniMAP
(EREKA) 2021
2. Scientific Research Secretariat for Perlis Research &
Quality Day 2018
Dr Amalina Anuar Medical
officer UD48
1. Scientific Research Secretariat for Perlis Research &
Quality Day 2018
OVERVIEW : ISR WORK PROCESS
IN HTF
STUDY DOCUMENT / IP / SAMPLE
STORAGE
◦ Each clinical trial documents and
study materials will be stored in a
dedicated steel locked cabinet
◦ Each cabinet will be labelled with
NMRR ID, Protocol number, protocol
title, sponsor, CRO and PI
◦ Investigational products (IP) are stored
in the 2-8° C pharmaceutical fridge
◦ Clinical trial samples are stored in -30°
C freezer before shipment to central
lab
Contingency Plan
for Sample
Storage in
Pharmaceutical
Freezer , HTF
PF : Pharmaceutical
Freezer
TG : Thermoguard System
Contingency Plan for
Investigational Products (IP)
Storage in Pharmaceutical
Fridge , HTF
PF : Pharmaceutical Fridge
IP : Investigational Products
TG : Thermoguard System
An introduction to Clinical Research Centre (CRC) Hospital Tuanku Fauziah

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An introduction to Clinical Research Centre (CRC) Hospital Tuanku Fauziah

  • 1. Clinical Research Centre Hospital Tuanku Fauziah Unit Profile
  • 2. Vision & mission Vision To become the leading clinical research institution in northern region of peninsular Malaysia. Mission To improve patients’ health outcome through ethical and quality clinical research. Establishment Clinical Research Centre Hospital Tuanku Fauziah, Kangar, Perlis (CRC HTF) was established on May 7th, 2007. Its main function is to establish conducive environment to enable ethical and quality clinical research projects to be carried out for the improvements of patients’ health outcome.
  • 3. Head of Unit 2007 Dr Sia Soon Keat Department of Internal Medicine 2008-2009 Dr Zalwani Zainuddin Department of Internal Medicine 2009-2013 Dr Yeap Ewe Juan Department of Orthopaedics 2014-2016 Dr Noram Azlan Ramli Department of Ophthalmology 2017-2019 Dr Nizar Bidin Department of O&G 2020 Dr Khairul Shakir Ab Rahman Department of Pathology 2021-2023 Dr Ruzita Jamaluddin Department of Psychiatry and Mental Health
  • 4. LEVEL 1, “BLOK KLINIK PAKAR” (NEXT TO “DEWAN INSANIAH”)
  • 7. CRC HTF STAFF Dr Ruzita Jamaluddin Head Consultant Psychiatrist UD56 2021 Ms Siti Ertina Asli CRM Study Coordinator 2009 SN Siti Zulaiha Che Hat Staff nurse U29 2018 Ms Nor Efarina Abdul Rahman Administrative assistant N19 2010 Mr Rohaizan Isa Operational assistant N11 2010 Dr Irma Liyana Mushaddik Deputy Medical officer UD52 2021 Mr Ang Wei Chern Admin manager Pharmacist UF48 2016 Dr Amalina Anuar Medical officer UD48 2018 Dr Noor Suhaiza Morat Medical officer UD52 2023
  • 8. CRC COMMITTEE MEMBERS : APPOINTMENT DATE 2022 - 2023
  • 9. HOSPITAL RESEARCH REVIEW COMMITTEE : APPOINTMENT DATE 2022-2023
  • 10. PERFORMANCE INDICATOR FOR CRC HTF 1. Number of NMRR registered IIR (Investigator Initiated Research) 2. Number of research collaboration with IPTA/IPTS 3. Number of publications : • Number of publications by CRC staffs • Types of published articles • Publication in high indexed journal 4. Number of ISR (Industrial Sponsored Research) 5. Research Consultations 6. CRC research training activities 7. CRC staffs achievements
  • 11. NMRR - REGISTRED IIR 2018 -2023 3 2 11 1 2 2 4 4 1 45 38 47 51 55 15 2018 2019 2020 2021 2022 2023 JKN PKD HTF Updated 1 April 2023
  • 12. No. NMRR ID Project Full Title Principal Investigator 1 NMRR ID-23-00175-ULY Knowledge, Attitude and Practice on Preparation and Administration of Intravenous Medications among Nurses in Hospital Tuanku Fauziah, Perlis SITI ZULAIHA BINTI CHE HAT 2 NMRR ID-23-00211-TFX COVID-19 and Climate Change: Prospects for a ‘Green’ Recovery in the Indian Ocean Region SEE MING SHE 3 NMRR ID-23-00225-FMQ KNOWLEDGE AND ATTITUDE ABOUT ACUTE DELIRIUM IN THE ELDERLY AMONG EMERGENCY DEPARTMENT DOCTORS IN MALAYSIAN GOVERNMENT HOSPITALS Mohd Johar Bin Jaafar 4 NMRR ID-23-00227-QKT Quality of Work-Life, Burnout and Professional Commitment among Nurses: A Multicentre Analysis Government and Private Hospitals in Malaysia VALERMATHIE A/P VELLU 5 NMRR ID-23-00239-RCQ Patient Profile and Mental Health Issues Among New Cases Referred To The Hospital Tuanku Fauziah Psychiatric Team Before, During And After The COVID-19 Pandemic: A 4-Year Retrospective Analysis Ruzita binti Jamaluddin 6 NMRR ID-23-00292-PWX The Local Needs and Gaps in Pharmacogenomics Knowledge and Education Among Healthcare Professionals in Malaysia: A Delphi Study Safa Hassan Mohamed Hassan Omran 7 NMRR ID-23-00295-9N5 Ketogenic diet in women with polycystic ovarian syndrome (PCOS): a systematic review and meta-analysis of clinical trials KARNIZA BT KHALID 8 NMRR ID-23-00407-YMC Perception of Pain among Surgical Ward Patients: A Cross-Sectional Study Jason Wong Soon Keong 9 NMRR ID-23-00604-FWH The Journey to Embryonal Rhabdomyosarcoma (FNCLCC Grade 2) detection: A Case Report NIK NUR FARAHIYAH@HIDAYAH BINTI NIK ZAINAL ABIDIN 10 NMRR ID-23-00746-2DH Shoulder dystocia: a review on incidence, maternal and perinatal risk factors and outcome Nur Farihan binti Mukhtar 11 NMRR ID-23-00756-KIH Faktor-Faktor yang Mempengaruhi Niat Penggunaan ICD-11 Dalam Kalangan Pegawai Tadbir Rekod Perubatan dan Penolong Pegawai Tadbir Rekod Perubatan di Fasiliti KKM Zaleha binti Md. Isa 12 NMRR ID-23-00957-FDQ AN ONLINE SURVEY OF AUDIOLOGIST’S AWARENESS AND PRACTICE OF AUDITORY PROCESSING IN MINISTRY OF HEALTH MALAYSIA MERLINDA W BERNARD 13 NMRR ID-23-01061-EM1 AUDIT ON READMISSION RATE OF UNSTABLE ANGINA CHUAH SEAN JYI 14 NMRR ID-23-01062-XDU Factors contributing to HPV vaccine hesitancy among adolescents and the recommended interventions: A review of quality improvement methodologies KARNIZA BT KHALID 15 NMRR ID-23-00538-T23 Cardiology Clinic Hospital Tuanku Fauziah Clinical Audit 2022: Adherence to ACEi/ARB in STEMI Patients Admitted to CCU HTF between January and June 2022 Khairul Azhar Bin Abu Bakar NMRR - REGISTRED IIR HTF, 2023
  • 13. No . NMRR ID Project Full Title Principal Investigator 1 NMRR ID-23-00410- 75L IDENTIFYING PREVENTABLE FACTORS FOR EARLY CASE DETECTION AND TREATMENT ADHERENCE IN LEPROSY Rafidah Binti Ali, MOHD FIRDAUS BIN RAZALI NMRR- REGISTRED IIR JKN PERLIS, 2023 No . NMRR ID Project Full Title Principal Investigator 1 NMRR ID-23-00587- ZAA Depression, Anxiety and Stress Among Pregnant Women in Perlis: A Cross Sectional Survey SITTI FATIMAH BINTI AJUI (KK Kangar, KK Beseri) NMRR- REGISTRED IIR PKD 2023
  • 14. 10 13 14 13 10 0 2 4 6 8 10 12 14 16 2019 2020 2021 2022 2023 No. Year Minimum 10 collaboration with IPTA/S in a year Updated 1 May 2023 RESEARCH COLLABORATION WITH IPTA/IPTS 2019-2023
  • 15. RESEARCH COLLABORATION WITH IPTA/IPTS 2023 No Research Title Main researcher at site Collaboration Institution Current status 1 Health Utility and Health-related Quality of Life of HIV Patients in a Malaysian State Hospital Ang Wei Chern (CRC HTF) Universiti Sains Malaysia Write-up (NMRR-21-1549-60908) 2 Prevalens dan Faktor-faktor yang Berkaitan Dengan Anemia Semasa Kehamilan: Sebuah Kajian Kuantitatif Dalam Kalangan Ibu Hamil Di Klinik Kesihatan Di Negeri Perlis Dr. Amalina Anuar (CRC HTF) Open University Malaysia (OUM) Report Writing (NMRR-22-02473-3DR) 3 RESOLVE-Randomised Evaluation of Sodium Dialysate Levels on Vascular Events Dr Wan Syamir Zharif bin Wan Ahmad Kammal (Nephro HTF) University of Sydney New site in HTF (NMRR-19-3823-52045) 4 Snakebite: Evaluation of Knowledge among Farmers in the State of Perlis Ang Wei Chern (CRC HTF) Universiti Kebangsaan Malaysia (UKM) Data collection (NMRR- 21-1797-61372) 5 Experience of preceptors on Provisional Registered Pharmacist (PRP) training programme in the state of Perlis, Malaysia: a qualitative study. Ang Wei Chern (CRC HTF) Universiti Kebangsaan Malaysia (UKM) Data collection (NMRR ID-22-02283-YCO) 6 Budget Impact Analysis of Ferric Derisomaltose for the Treatment of Iron-Deficiency in Malaysia Ang Wei Chern (CRC HTF) Monash University Malaysia Pending publication in MJMHS 7 Factors affecting choice of post graduate training pathway in internal medicine in Malaysia Datuk Seri Dr Paras Doshi (Medical HTF) University of Cambridge Protocol writing and NMRR registration 8 Breast cancer status, grading system, etiology, and challenges in Asia: an updated review Dr Khairul Shakir Ab Rahman (Pathology HTF) Universiti Malaysia Perlis (UniMaP) Published in 2023 https://doi.org/10.1515/ oncologie-2022-1011 9 Morphological features-oriented fusion extraction method for quantification of tubules and non-tubules in breast carcinoma Dr Khairul Shakir Ab Rahman (Pathology HTF) Universiti Malaysia Perlis (UniMaP) Applying FRGS grant and NMRR 10 A novel formulation of automated tumor volume detection and characterization method using fusion feature extraction Dr Wan Irnawati Wan Ab Rahman (Radiology HTF) Universiti Malaysia Perlis (UniMaP) Applying FRGS grant and NMRR
  • 16. MSQH Std 26.5.1.6b Bilangan penerbitan: Minimum 2 setahun (sebagai denominator) Updated 1 May 2023 PUBLICATION ACHIEVEMENT 2018-2023
  • 17. CRC STAFFS ACHIEVEMENTS IN PUBLICATIONS 2021-2023 14 17 5 10 17 10 0 5 10 15 20 25 30 35 40 2021 2022 2023 CRC non-CRC 24 34 15
  • 18. TYPES OF PUBLISHED ARTICLES 2021-2013 16 24 10 6 6 3 2 4 2 0 5 10 15 20 25 30 2021 2022 2023 Original article case report review article
  • 19. PUBLICATIONS IN HIGH INDEXED JOURNALS 2021-2023 *High indexed journal : Web of Science (SCI or SCIE) / Scopus 11 17 8 13 17 7 0 2 4 6 8 10 12 14 16 18 2021 2022 2023 high indexed journal non high indexed journal
  • 20. No Author Title Journal High index journal IF SJR 1 First author: Dr Nur Farihan Mukhtar (O&G, HTF) Paracetamol as analgesia following Spontaneous Vaginal Delivery: Reappraisal of Practice The Malaysian Journal of Nursing - - - 2 First author: Ruzita Jamaluddin (Psychiatry & CRC, HTF) Lithium toxicity in a patient with bipolar disorder: Lesson learned Current Psychiatry Scopus (Q4) - 0.14 3 Co-author: Dr Khairul Shakir Ab Rahman (Pathology Department , HTF) Pap Smear Images Classification Using Machine Learning: A Literature Matrix Diagnostics WoS (SCIE) Scopus (Q2) 3.992 0.66 4 Co-author Dr Khairul Shakir Ab Rahman (Pathology Department, HTF) Artificial Intelligence (AI) in Breast Imaging: A Scientometric Umbrella Review Diagnostics WoS (SCIE) Scopus (Q2) 3.992 0.66 Publications from HTF 2023
  • 21. No Author Title Journal High index journal IF SJR 5 First author: SN Siti Zulaiha Che Hat (CRC, HTF) Mental Health Burden from COVID-19: Findings from a Single Hybrid Hospital in Northwest Malaysia Malaysian Journal of Medicine and Health Sciences Scopus (Q4) - 0.14 6 Co author: Ang Wei Chern (CRC, HTF) Exploration of hybrid deep learning algorithms for covid-19 mRNA vaccine degradation prediction system International Journal of Advances in Intelligent Informatics Scopus (Q3) - 0.39 7 First author Dr Syuhaida Shuib (Emergency Department, HTF) Holistic Approach to Ecstasy-induced Atrial Fibrillation in a Young Patient: A Case Report Malaysian Journal of Medical Research - - - 8 Co-author Dr Khairul Shakir Ab Rahman (Pathology Department , HTF) Fuzzy Relevant Regions Segmentation in Breast Histopathology Images using FCM 2022 IEEE International conference on Automatic Control and Intelligent Systems (12CACIS) - - -
  • 22. No Author Title Journal High index journal IF SJR 9 Co-author Dr Khairul Shakir Ab Rahman (Pathology Department , HTF) A Non-Mitosis Reduction Method using Semantic Descriptors for Breast Cancer Mitosis Detection Application 2022 IEEE International conference on Automatic Control and Intelligent Systems (12CACIS) - - - 10 Co-author: Dr Khairul Shakir Ab Rahman (Pathology Department , HTF) Nuclei Segmentation in Breast Histopathology Images using FCM 2022 IEEE International conference on Automatic Control and Intelligent Systems (12CACIS) - - - 11 Co-author: Dr Nur Diana Mastura Zulkifli (Pathology Department , HTF) Smart Management Waiting System for Outpatient Clinic Journal of Advanced Research in Applied Sciences and Engineering Technology - - - 12 Co author Dr Khairul Shakir Ab Rahman (Pathology Department , HTF) Breast cancer status, grading system, etiology, and challenges in Asia: an updated review Oncologie Journal Scopus (Q4) - 0.14
  • 23. No Author Title Journal High index journal IF SJR 13 Co-author Dr Muhammad Ridwan Yeop Ismail (OMF, HTF) Perception Regarding the NICE Guideline on Antibiotic Prophylaxis against Infective Endocarditis Following Dental Procedures: A Cross-Sectional Study MDPI antibiotics WoS (SCIE) Scopus (Q1) 5.22 0.97 14 First author: Ang Wei Chern (CRC, HTF) Inequalities in Consumption Expenditure on Pharmaceuticals: Evidence from Malaysia International Journal of Social Determinants of Health and Health Services WoS (SCIE) 1.851 - 15 First author: Irma Liyana Mushaddik (CRC, HTF) The rare case of synchronous multiple primary malignancies of invasive ductal carcinoma and diffuse large B-cell lymphoma in a single patient: A diagnostic conundrum Medical Journal of Malaysia Case Reports - - -
  • 25. 3 3 2 5 2 0 1 2 3 4 5 6 2019 2020 2021 2022 2023 No. Year Updated 1 May 2023 Industrial Sponsored Research (ISR) Involvement 2019-2023
  • 26. ISR Principal investigator Site Department Title of study Sponsor Year activated Year completed Dr Ruzita binti Jamaluddin HTF Psychiatry Confirmatory Study of DSP-5423P in Patients with Schizophrenia (Phase 3) Sumitomo Dainippon 2017 2018 Dr Siti Akma binti Ishak HTF Paediatrics A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 years) with Type 2 Diabetes Mellitus Janssen 2018 Ongoing Dr Siti Akma binti Ishak HTF Paediatrics A Phase III, Randomized, Observer-bind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus’ Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non- Influenza Vaccine when Administered in Healthy Subjects aged 6 months through 47 Months Seqirus 2019 2020 Dr Siti Akma binti Ishak HTF Paediatrics A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >28 Days and <3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection Janssen 2019 2022 Dr Suhaila binti Ab Wahab HTF Internal Medicine A Phase 2b, Randomized, Double-Blind, Placebo- Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP) Enanta Pharmaceutical s - 2022 (Premature closure) Dr Suhaila binti Ab Wahab HTF Internal Medicine A Randomized, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects Kintor Pharmaceutical s 2022 2022 Dr Noorhafini binti Abdul Sukur HTF Internal Medicine Randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease Boehringer Ingelheim 2022 Ongoing List of ISR in Perlis
  • 27. NO TITLE OF STUDY PI TARGET ACHIEVED STATUS 1 A Randomized, Multicenter, Double-Blind, Parallel- Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 years) with Type 2 Diabetes Mellitus Dr Siti Akma binti Ishak 2 2 2 subjects completed the study visit. Awaiting for Close out visit 2 Randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non- diabetic chronic kidney disease Dr Noorhafini binti Abdul Sukur 2 1 ongoing ONGOING ISR IN HTF : CURRENT STATUS
  • 28. 4 4 5 4 5 3 0 1 2 3 4 5 6 2018 2019 2020 2021 2022 2023 No. Year CRC RESEARCH TRAINING ACTIVITIES 2018-2023 MSQH Std 26.5.1.6a Bilangan latihan dianjurkan: Minimum 2 setahun (sebagai denominator) Updated 5 May 2023
  • 29. No. Event / Workshop / Course Date Venue 1. Good Clinical Practice (GCP) Workshop 07/03/2023 (Tuesday) - 09/03/2023 (Thursday) Online & Putra Regency, Perlis / Hotel Seri Malaysia, Perlis 2. Introduction to Clinical Research (ICR) 13/03/2023 (Monday) - 14/03/2023 (Tuesday) Online - zoom 3. Protocol Writing & NMRR Registration Workshop 16/03/2023 (Thursday) - 17/03/2023 (Friday) Bilik Gerakan, JKN 4. Basic Biostatistics Workshop 07/06/2023 (Wednesday) - 08/06/2023 (Thursday) Dewan MRI, HTF/ Bilik Gerakan, JKN 5. Publication Retreat Workshop 14/06/2022 (Wednesday) - 16/06/2023 (Friday) Bilik Gerakan, JKN 6. Hari Kualiti & Penyelidikan 2023 26 – 27 October 2023 JKN Perlis 7. Research Consultation Clinic (RCC) Appointment basis CRC Office, HTF CRC RESEARCH TRAINING ACTIVITIES 2023
  • 30. Good Clinical Practice 2023 on 7th – 9th March 2023
  • 31. Introduction to Clinical Research 2023 on 13th -14th March 2023
  • 32. Protocol Development & NMRR Registration 2023 on 16th – 17th March 2023
  • 34.
  • 35. Snippet from CRM bulletin Issue 12 STAR Recruiter Award for BRILLIANT Study Principal investigator: Dr Ruzita Jamaluddin Department of Psychiatry and Mental Health HTF
  • 36. Snippet from CRM bulletin Issue 20 Rising Stars in Paediatrics Dr Siti Akma Ishak Department of Paediatrics HTF
  • 37. Awards Recipient MR ANG WEI CHERN CRC ADMIN MANAGER / PHARMACIST 2021 1 Best Oral Presentation 3rd World Congress on Integration & Islamicization (IMAM) 2021 2 Outstanding Poster Award National Pharmacists Convention 2021 3 Young Investigator Award (Clinical) National Institute of Health (NIH) 2022 1 2nd place oral presentation 23rd Islamic Medical Association of Malaysia (IMAM) 2 2nd runner up poster presentation 15th National Conference for Clinical Research (NCCR)
  • 38. 2nd place oral presentation 23rd Islamic Medical Association of Malaysia (IMAM) Annual Scientific Conference 8-9 Oct 2022 2nd runner up poster presentation 15th National Conference for Clinical Research (NCCR) 18-20 Oct 2022
  • 39. Awards Recipient DR KARNIZA BINTI KHALID DEPUTY HEAD / MEDICAL OFFICER UD 52 2021 1 Best Oral Presentation 9th International Conference on Biological & Medical Sciences, Suzhou, China (ICBMS 2021) [Virtual meeting] 2022 1 3rd place Oral Presentation – RCSI & UCD Medical College (RUMC) Research Day 2022 [Virtual meeting] 2 2nd place ePoster Presentation 26th Malaysian Society of Paediatric Haematology and Oncology (MASPHO) Annual Scientific Meeting [Virtual meeting]
  • 40. RCSI & UCD (RUMC) Research Day 2022
  • 41. CRC HTF was ranked 1st for no. of ongoing research on COVID-19 among all CRC network in Malaysia (Jan-Jun 2021) Source: CRC Network Meeting 02-Sep-2021
  • 42. CRC HTF was ranked 2nd for no. of publications among all CRC network in Malaysia in Jan-Jun 2021 Source: CRC Network Meeting 02-Sep-2021
  • 43. Contributions from CRC staff Dr Ruzita Jamaluddin Head of Unit 1. Panel Jawatankuasa Etika Penyelidikan Manusia UniMAP 2021-Current 2. Industry panel for AHIBS Action Research Challenge 2021 Dr Karniza Khalid Deputy / Medical officer UD52 1. Panel Jawatankuasa Etika Penyelidikan Manusia UniMAP 2021-Current 2. Panel for state level QA projects presentation (JKN Perlis) 2022 3. Industry panel for AHIBS Action Research Challenge 2021 4. Elected as expert panel for Projek Kajian Awal Dasar Perpaduan Negeri Selangor by Institut Kajian Etnik UKM Bangi 2021 Mr Ang Wei Chern Admin manager / Pharmacist 1. Jury for Research and Innovation Exhibition UniMAP (EREKA) 2021 2. Scientific Research Secretariat for Perlis Research & Quality Day 2018 Dr Amalina Anuar Medical officer UD48 1. Scientific Research Secretariat for Perlis Research & Quality Day 2018
  • 44. OVERVIEW : ISR WORK PROCESS IN HTF
  • 45.
  • 46. STUDY DOCUMENT / IP / SAMPLE STORAGE
  • 47. ◦ Each clinical trial documents and study materials will be stored in a dedicated steel locked cabinet ◦ Each cabinet will be labelled with NMRR ID, Protocol number, protocol title, sponsor, CRO and PI
  • 48. ◦ Investigational products (IP) are stored in the 2-8° C pharmaceutical fridge ◦ Clinical trial samples are stored in -30° C freezer before shipment to central lab
  • 49. Contingency Plan for Sample Storage in Pharmaceutical Freezer , HTF PF : Pharmaceutical Freezer TG : Thermoguard System
  • 50. Contingency Plan for Investigational Products (IP) Storage in Pharmaceutical Fridge , HTF PF : Pharmaceutical Fridge IP : Investigational Products TG : Thermoguard System