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January 2016 Volume 1, Issue 1 Research Quarterly Newsletter To support Clinical Research locally..... Special points of interest: NMRR Updates Pahang Research Day 2015 Tips for Budget Negotiations Message from the Editor Welcome to the first edition of the Research Quarterly Newsletter, published in print and online three times a year. The last year was busy in Clinical Research Centre (CRC) Pahang with the revision of our new service, Research Consultation Clinic, Promoting Research Awareness through Clinical Research Malaysia (CRM) collaboration, research-related training, and assisting investigators for ongoing clinical trials and shifting to the new CRC office. These news will be discussed in this issue, as well as other supporting resources for clinical research.The research-related training is just around the corner. Please see the post below for further details and review the calendar at the end of this newsletter for upcoming events. Thank you for reading and have a great year ahead in 2016!! Message from the Editor 1 CRC Spotlights 1 News & Activities 2 Research Quality & Compliance 7 Connecting Research 10 Clinical Trial Resources 11 Arrivals & Departures 11 Upcoming Events 12 Inside this issue: Dr. Selva Kumar A/L Sivapunniam Editor-in-Chief CRC Pahang Spotlights In order to help researchers in the next five years, CRC Pahang is pleased to offer its service, Research Consultation Clinic. Research Officers /Pharmacists/ Medical Officers Rotation will be trained at CRC site to increase the reach of services to investigators who are keen but have no experience or with little knowledge at the institution where they wish to do the research. The teams work together to assist investigators in conducting all phases of clinical research from design to implementation to analysis and reporting of results. Continued on page 3 1

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Page 1: Research Quarterly Newsletter

January 2016Volume 1, Issue 1

Research Quarterly

Newsletter

To support Clinical Research locally.....

Special points of interest:

∗ NMRR Updates

∗ Pahang Research Day 2015

∗ Tips for Budget Negotiations

Message from the EditorWelcome to the first edition of the Research Quarterly Newsletter, published in print and online three times a year. The last year was busy in Clinical Research Centre (CRC) Pahang with the revision of our new service, Research Consultation Clinic, Promoting Research Awareness through Clinical Research Malaysia (CRM) collaboration, research-related training, and assisting investigators for ongoing clinical trials and shifting to the new CRC office. These news will be discussed in this issue, as well as other supporting resources for clinical research.The research-related training is just around the corner. Please see the post below for further details and review the calendar at the end of this newsletter for upcoming events. Thank you for reading and have a great year ahead in 2016!!

Message from the Editor

1

CRC Spotlights 1

News & Activities 2

Research Quality & Compliance

7

Connecting Research 10

Clinical Trial Resources

11

Arrivals & Departures

11

Upcoming Events 12

Inside this issue:

Dr. Selva Kumar A/L SivapunniamEditor-in-Chief

CRC Pahang SpotlightsIn order to help researchers in the next five years, CRC Pahang is pleased to offer its service, Research Consultation Clinic. Research Officers /Pharmacists/ Medical Officers Rotation will be trained at CRC site to increase the reach of services to investigators who are keen but have no experience or with

little knowledge at the institution where they wish to do the research. The teams work together to assist investigators in conducting all phases of clinical research from design to implementation to analysis and reporting of results.

Continued on page 3

1

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CRC Pahang & CRM Achievements

2 Research Quarterly Newsletter

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3Volume 1, Issue 1

Continued from page 1

Also on the top of the list is continued partnerships withother (i.e., International Islamic University Malaysia, IIUM) to maximize support of investigators.

An APPOINTMENT is required (2 days beforehand), and maybe made by email or by phone: Email: [email protected]: 09 557 2922

Every Monday, Wednesday &

Friday

2.30 pm – 4.30 pm (Mon & Wednesday)

8.00 am – 12.00 pm

(Friday)

Appointment time will be allocated.

News & Activities(1) The Past, Present, & Future of CRC PahangThe renovation and asset acquirement for CRC Pahang was completed in 30th November 2015. CRC Pahang has an office which is situated in the ground floor of Bangunan Pentadbiran HTAA and equipped with rooms dedicated for research activities and a laboratory samples storage in Ambulatory Care Centre (ACC), Level 4 (Pejabat Pakar). Below are the pictures of CRC from the beginning of time to the newly completed CRC HTAA.

Established in 2003, and previously known as the CRC HTAA, the centre operated on Level 4, ACC Building until 2013 then moving up to Level 5 in the same building from 2013 until 2015. This scattered existence made it challenging to collaborate and collectively share research ideas. We finally have ourown space for clinical research activities and monitoring visits space. Thanks to our HTAA Director, Dato’ Dr. Ardi Bin Hj. Awang, Deputy Director (Medical), Datin Dr. Gowri Sundaram, and Chief Executive Officer (CEO) of Clinical Research Malaysia (CRM), Dr. Akhmal Yusof for sponsorship.

Continued on page 4

2004 2010 2013 - 2015

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Continued on page 3

(2) Site Initiation Visit (SIV) - Medical Department, HTAA1st December 2015: FLASH Study was initiated at HTAA. The purpose of the study was to investigate whether switching symptomatic Chronic Obstructive Pulmonary Disease (COPD) patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow, and to assess the effect on symptom burden, breathlessness, and use of rescue medication. The study was led by Dr. Aishah Bt. Ibrahim, Respiratory Medicine Specialist.

New CRC Pahang Office Timeline:

* RM 110 thousands budgeted for construction with building completion slated for November 2015. * Unit Pembangunan HTAA & CRM was chosen to oversee the design and construction.

* CRC & CRM staffs are moving to the new office ahead of schedule in the mid of December 2015.

* Terms & Condition was conducted on 4th December 2015 and 6th January 2016.

Respiratory study team with the Clinical Research Associate (CRA) from the sponsored site, Novartis.

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Oral Presenters..Overall, weak research design. No standardization in data collection, Old citation for literature & lengthy words in slide presentation.

Assoc. Prof. Jamalludin Ab. RahmanEpidemiologist & Biostatistician, IIUM

(3) Clinical Research Spirit - Pahang Research Day 2015!!17th November 2015: Pahang Research Day started with five plenaries in the morning session and then followed by oral and poster presentations in the evening ,concurrently. The theme for year 2015 is Borderless research: Merging Public Health and Clinical Research. A total of 283 delegates attended with 36 (oral & poster presenters)

during the research day. We have opened up CRC and CRM booth to connect with the attendees. For the quality of scientific presentation, we would like to share some comments received from the Judges.

Poster Presenters..Outlook and Poster title appeared to be ‘less catchy’ resulted in lack of stamina for overall presentation. Objectives were not clear & data not well analyzed.

Dr. MahadevanHead of CRC Seremban

Congratulations to our Research Day Winner

Poster: Name: Dr. Aida Suhana Bt. Rosly Department: Pathology Hospital/Institution: Hospital Tengku Ampuan Afzan, Kuantan (Top, Left)

Oral:Name: Dr. Nur Nadiah PuteriDepartment: NephrologyHospital/Institution: Hospital Tengku Ampuan Afzan, Kuantan (Below, third counted from Left)

Volume 1, Issue 1 5

Poster (Case Report)..Some cases presented have unique features (e.g. Diagnosis & Radiology Findings. Posters were too wordy and poor printing quality.

Dr. Goh Pik PinDirector of National CRC

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(4) Research Awareness Programme -- (Roadshows)

From 30th September till 20th October 2015: CRC & CRM had visited the Ministry of Health (MOH) facilities in order to expand our vibrant research environment. We had visited the Hospitals with specialists and Klinik Kesihatan. The purposes of the roadshows were to:

* raise awareness of the importance and relevance of research at MOH facilities, which later impact the MOH staffs to involve in investigator initiated research, including ISR.

* explore new site for conducting ISR.

* develop, promote, and support researchers to engage with local research in Pahang.

* share examples of good practice from experienced investigators in their involvement of research with a view to learning in and beyond our locality, and applying this learning into good research practice.

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Who should sign the Investigator Agreement-Head of Department – Institutional Approval (IA-HOD-IA) Form?

7Volume 1, Issue 1

Research Quality & Compliance

National Medical Research Register (NMRR) Updates

Source: adapted from National Medical Research Register website

What is NMRR?● NMRR is a web portal to track status / progress of research / provided funding support for medical research.

Why I should register in NMRR?

● To support implementation of the National Institute of Health (NIH) guideline on the conduct of research in the MOH. ● For publicly accessible research registers.● Ensure transparency and to increase public trust in the conduct of medical research.

Who should register in NMRR?Registration of all research that involves:● MOH personnel OR ● to be conducted in MOH facility OR ● to be funded by MOH research grant

Investigator from Head of Department Institutional Approval

University/ College (e.g.Student/Lecturer)

Respective Head of Unit/Department

Rector/Dean of the Faculty

Health Clinic (MOH) Health District Officer ‘PKD’Director of State of Health Department ‘JKN Pahang’

Hospital (e.g. Private / MOH) Respective Head of Department Hospital Director/ Chief of Executive Officer

Continued on page 8

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Continued from page 7

PRINCIPAL INVESTIGATOR‛S RESPONSIBILITIES

Web-based Registration & Submission of Research through NMRR

3 MONTHS OR MORE

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Getting Approval at Research Site

Notes: 1. A human subject (in the context of research) is ‘a living individual about whom an investigator obtains either data through intervention (e.g. clinical trial) or interaction (e.g. questionnaire in health survey) with the individual, or identifiable private information’. 2. Refer to page 7 in this newsletter on obtaining signature for IA-HOD-IA form if you’re from different institution. 3. Research application form (only applicable to those who conduct study in HTAA). 4. Cover Letters refers to Appendix 5(a) applicable for all investigator and Appendix 5 & 5 (b) only applicable for investigator who came from different institution. Template can be obtained from CRC Pahang or can be downloaded in https://www.nmrr.gov.my/doc/NIH_Guidelines_Oct_2015.pdf 5. Research documents (research proposal/protocol; consent form, questionnaire; IA-HOD-IA form) 6. Quality Unit: For those Hospitals without CRC, appointed by the Director of the respective Hospital to oversight the research registration in their respective hospital.

PI submit the following documents to CRC / Respective Quality Unit6:a) Research Application Form3

b) Cover Letters4

c) Research Documents5

Notification is treated and request for authorization on respective HODs & Hospital Director within 7 Working Days

CRC/ Respective Quality Unit provides response to Principal Investigator (PI) within 2 Working Days upon valid and complete signature from respective

department & institutional director

PI continued to upload documents in section 7 (NMRR)

Obtained approval from MREC

PI presented the MREC approval letter & Cover Letters4 to respective department to conduct study

Study End

Reject / Not

approved

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Connecting Research

Chit-Chat Corner

Dr. Tee Hoi Poh was a Medical Officer at the Medical Department in Hospital Tengku Ampuan Afzan. Currently, he is a Gastroenterologist and Hepatologist.

1. How you join in Industry Study Research (ISR)? I first involved in ISR in 2007 when I was a trainee in Gastroenterology in Queen Elizabeth Hospital, Kota Kinabalu where I was given the task to conduct a ISR using a new proton pump inhibitor in treating peptic ulcers. In Kota Kinabalu, there are many cases of peptic ulcer disease due to widespread use of NSAIDs. Our centre was the top recruiting site for that trial in Malaysia. Ever since that trial, I have been attracted to ISR.

3. What research are you interested in? My research areas are Chronic Hepatitis C, inflammatory bowel disease, peptic ulcer diseases, steatohepatitis to name a few.

4. As clinician, how do you divide your time between clinical and research work?

I have dedicated clinical research coordinators who plan out visits on my free time. They will handle the correspondence, beaurocracy, laboratory, finance, and data management for me so that I can concentrate only in patient recruitment and safety issues. The CRM is an organization that provide experience Study Co-ordinators to help in clinical trials. I strongly recommend all PIs to utilize their services.

5. Do you have any advice for other young researchers? One of the excitement in clinical work is to be able to keep up with the latest advances in medical world. ISR is a venue for you to be at a level parallel to the world's best. At times when I attend investigator meetings I feel I am a member of esteemed society that is witnessing the ground-breaking research that would change daily clinical practices. For young investigators out there, ISR will be the venue for good exposure and experience.

2. What motivates you to do research? Government hospitals in Malaysia do not have enough budget for medications to treat patients. ISR allows the conducting units to save budget in medications since they will be provided for free. Moreover some of these medications are latest medications that are not available in the market. It provides an attractive treatment option for our patients. In fact, especially in oncology, treating patient with trial medications has been a norm and remain an option highly sought for. I generally try to secure a trial each for every gastroenterology and Hepatology diseases so that my patient will have the extra options that other centre will not be able to provide. Clinical trial requires stringent measures in every aspect of management. The clinical research assistants will make sure all steps are conducted according to protocols, designed by top investigators in the world. Many a times, I learned the proper management of a disease from clinical trials.

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11Volume 1, Issue 1

No. Study Name PI Sponsor

1. GS-US-342-1518 Gilead (Hep C) Dr. Tee Hoi Poh Gilead

2. GP17-302-Rheumatoid ArthrITIS Dr. Hilmi B. Abdullah Sandoz

3. Amen extension study Dr. Hilmi B. Abdullah Boehringer Ingelheim

4. ASP 8273(CA Lung) Prof. Dr. How Soon Hin Astella Pharma Global Development Inc.

5. MPDL 3280(CA Lung) Prof. Dr. How Soon Hin Roche

Upcoming New Clinical Trials in HTAA

We are delighted to welcome Adibah Hamiza Bt. Ahmad Suhaimey,who joins the CRM group as a new Study Coordinator and Pavithra Janarsan as the newlyappointed Assistant Regional Manager (ARM) covering East Coast to replaceWong Sok Yee.

We wish Wong Sok Yee (as Quality Control Assistant Manager in CRM Headquarter, Kuala Lumpur) and Ngoh Teck Keong (as SC in Singapore) havea great success in their careers.

Arrivals & Departures

Clinical Trial ResourcesTips for Budget Negotiations

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CRC is currently looking to fill the following positions: 1. Pharmacists 2. Medical Officers

Editorial Editor-in-Chief

Dr Selva Kumar A/L Sivapunniam

Managing Editor Dr. Fariz Safhan Mohamad Nor

Writers

Fatihah Mahmud Lim Bee Chiu

Pavithra Janarsan

Apps & Software for Research n4Studies makes it easy to calculate the sample size and the power of a study. It is a free App (for Android, iPad and iPhone) and comes with ABSOLUTELY NO WARRANTY.

Upcoming Events

1. CRC & CRM Roadshows (January – February 2016, all specialists hospital in Pahang)

2. Introduction to Clinical Research (23rd - 25th February 2016, HTAA)

3. Advanced Statistics Workshop (April 2016, ICT Lab 2, IIUM, Indera Mahkota Campus)

Full details coming soon...

You are welcome to contribute...

To contribute (news & event, publication, articles of interest, etc.), please call us or

email to [email protected] or [email protected]

Contact Us

Ground Floor, Administrative Building, Hospital Tengku

Ampuan Afzan, Jalan Tanah Putih, 25100 Kuantan

Phone: + 609 557 2922 / 2923 Fax: +609 5139378

E-mail: [email protected]