Investigator Guide

What is CRM?

CRM is a non-profit organisation, formed as an Entry Point Project 2 (EPP2) under the National Key Economic Area (NKEA). It was previously a unit under Clinical Research Center before it was corporatized into a separate entity on 15 June 2012. It runs as a private company, however it is fully government owned and the members of the Board of Directors are government officials. CRM’s vision is to make Malaysia the preferred destination for clinical trials. Its Key Performance Index is to have 1000 ongoing trials in Malaysia by year 2020

What is the general function of CRM?

CRM was formed as a one stop centre for Industry Sponsored Research in Malaysia. It functions as facilitator for all things related to Industry Sponsored Research and liaises with the government, sponsors, CROs and Investigators on various levels. CRM drives the success of ISR Clinical Trials by

  • Approaching new sites
  • Compiling a database of Investigators
  • Training new potential Investigators
  • Promoting feasibility
  • Reviewing CTA and trial budget
  • Managing trial payment as instructed by Principal Investigator
  • Providing trained Study Coordinators

How does this benefit me as an investigator?

CRM strives to smoothen the process of clinical trials for the Investigator at all levels.

  • Feasibility: CRM staff will meet with you to introduce and guide you through the feasibility questionnaire that comes in. They will help answer questions you may have as you go through the feasibility. For sites without CRM staff, CRM staff may personally contact you via teleconversation to discuss the trial before emailing it to you.  
  • Trial budget and payment: CRM will review the trial budget and manage payment from Sponsor as directed by the Principal Investigator. This alleviates the need for you to handle payment to the respective parties yourself.
  • Running of Trials: CRM will provide Study Coordinators to help you with running your ISR and CRM will continue to train them to excel in this field.  

Is CRM a Contract Research Organisation?

No, CRM functions as an independent entity which facilitates Clinical Research at all levels and adds value to the procedures already in place (as mentioned in Question 3).

What is the differences between CRM & CRC (Clinical Research Centre)?

CRM

CRC

Previously a unit under CRC, but was corporatized in 2012 Formed since 2000
Facilitates Industry Sponsor Research (ISR) Facilitates Investigator Initiated Research (IIR)
Provides Study Coordinators for ISR Provides Study Coordinators/Contractual Workers (“”Pekerja Sambilan Harian) for IIR
Receives and executes disbursement of sponsor’s study budget based on Principal Investigator’s intent Does not handle trial budgets except when payment is transferred from CRM into CRC Trust Fund for payment to MOH Staff
Corporatised Private Entity (owned by government) Government Unit
Headquarters at Amcorp Business Suites, Petaling Jaya Headquarters at Hospital Kuala Lumpur

What is the difference between Industry Sponsored Research and Investigator Initiated Research?

Industry Sponsored Research (ISR)

Investigator Initiated Research (IIR)

Topic of research decided by Pharmaceuticals Topic of Research decided by Specialists themselves
Usually involves drug development Involves topics on registered drugs/epidemiological/behavioral topics
In Malaysia, overseen by CRM In Malaysia, overseen by CRC
Study Coordinators may be supplied by CRM Study Coordinators may be supplied by CRC
Multicentre Can be single site or multicentre cooperation
Involves feasibility Does not involve feasibility
Publishing rights are determined by sponsor Publishing rights go to the specialists involved
Funds from Sponsor Grants from Government (MOH/MOHE/MOSTI etc) or Trust Funds

Both require Investigator and staff to be GCP qualified

Is it compulsory for us to have the study budget managed by CRM?

No, you may choose to follow the previous procedure at any time, i.e. you may go through society and manage the study  on your own. However, with reference to the circular signed by the Director General of Health on 6 November 2012, the 15% management fee is still to be paid by sponsor to CRM. This will replace the 15% institutional overhead charge previously paid to NIH.

 

Understood that CRM receives 15% on top of the total trial budget. Does this eat into the budget allocated for our trials?

No, CRM does NOT take 15% of the trial budget. 15% will be allocated by sponsor on top of the 100% trial budget, making it a total payment of 115%. 100% goes to the trial budget and 15 % goes to CRM for running costs (management fee).

 

So this means sponsor has to pay 15% more of the usual 100% allocated for trials? Would’t this be additional cost for them?

Before the corporatisation of CRM, the additional 15% was paid by the sponsor to NIH as an institutional overhead charge. The 15% to CRM has replaced the one to NIH, thus there is no additional cost to the sponsor.

 

As CRM is a new body formed to execute Investigators’ management of their budgets, how is the flow of this process carried out?

For specific details on the flow of trial budget management, you are welcome to contact the Head of Clinical Operations / Senior Research Manager.

CRM provides Study Coordinators to help us with Industry Sponsored Research at our site. Can we hire our own Study Coordinators for our own Industry Sponsored Research? How are they paid?

Yes, you can hire your own study coordinator instead of using CRM’s. If your Study Coordinator is hired by CRM, his/her salary will be paid by CRM and the amount allocated for him/her in the trial budget will be deducted by CRM. If you hire your own Study Coordinator, the allocation for his/her salary will be from the trial budget.

 

What is a Feasibility Study and why is it important?

In Industry Sponsored Research, feasibility studies are created by the Sponsor. As indicated by the name, feasibility studies are conducted to find out if an upcoming clinical trial is feasible in the targeted site (e.g whether there is a good patient pool, adequate facilities and manpower etc). It is conducted by disseminating a feasibility questionnaire to the doctors for completion. It is the first step to bringing an ISR clinical trial into a site, as it is from the feasibility answers that the sponsor will decide whether to pick a site for the trial.

Why are there so many feasibility questionnaires sent to me but no selection of my site?

The site selection process carried out by sponsor is usually completed many months from the date of feasibility deadline (estimated at least 5 months, but duration varies based on sponsor). As this is a multicentre trial, globally held and coordinated, they will take time to compare the feasibility results of all the countries approached and make their decision. At CRM, we strive to follow-up with sponsor’s decision of selecting sites to understand the reasons for site selection and non-selection.

There are many reasons for selection or non-selection of a site. Not all sites that responded positively in the feasibility questionnaire are selected. Some of the main reasons cited by CRO are lack of patient pool and facilities on site. If you would like to know the results or progress, you are most welcome to contact the person who approached you for the study, whether a CRM staff or CRA.

Why should I fill in the feasibilities by the deadline?

In ISR, the feasibility deadline is set by the sponsor as a globally coordinated deadline. If there is any delay in submission, the Investigator runs a risk of not being considered for the selection process.

I am very busy with my daily routine, how am I supposed to fill in the Feasibility Questionnaire by the deadline?

There are a few ways to make filling a feasibility questionnaire faster and simpler and at CRM we aim to put these practices into place. We strive to send the questionnaire directly to you personally in a short time span convenient to you. As long as you allow it, the CRM staff sent to you will introduce the study and answer any questions you may have on the spot. If there are questions that you feel should be answered by other departments such as Pharmacy/Laboratory/Imaging etc, they will help to obtain their answers to complete the questionnaire. If there are parts of the questionnaire where the CRM staff can answer on your behalf, they will do so (such as questions on storage space, your professional details including hospital and hospital address etc).

If there is currently no CRM staff stationed at your site, we will email you the protocol and contact you via mobile in your free time to discuss on it.

 

What’s the difference between CRM approaching me for a feasibility and Clinical Research Associates (e.g. from Parexel, Quintiles, Covance etc) approaching me for a feasibility?

Ultimately the goal is the same, that is to bring the feasibility to you and to get valuable feedback (both positive and negative) on a study. The CRA may choose to contact you directly or to go through CRM. Either way, your feedback is returned to the CRA in charge and they will relay it to the sponsor.

In view of all the information above, Industry Sponsored Research sounds like a tedious process. Why should I involve myself?

There are many benefits from doing Industry Sponsored Research and the benefits will not only be enjoyed by you but also the people around you.

Benefits to the Investigator

  • Able to learn the official process of conducting research, guided by the monitors sent to your site. This experience will develop your skill to put the best practices in place not only for future ISR trials but for your own initiated trials. 
  • Another chance to attend fully sponsored meetings with Investigators from other countries and exchange information on your topic of specialty.
  • To be known globally by the leading pharmaceutical companies who will keep you in mind for further groundbreaking trial drug developments
  • Additional income can be used for personal development, development of staff or department (e.g. sending staff for training, buying additional equipment for departmental use etc).

Benefits to the Patient

  • Offers patients new options for therapy, especially when current treatment options are limited
  • When the trial drug is marketed, it will be easily brought into Malaysia since it was previously tested in Malaysia. This means patients will have sooner access to these newest therapies.

Benefits to Hospital and Hospital Staff

  • Hospitals that successfully conduct clinical research on trial drugs which are later marketed are renowned by the industry to be good sites with good facilities and well trained staff, which helps build a good name for these hospitals globally.  
  • Increased number of clinical trials brought into Malaysia would mean increased job opportunities and additional income for hospital staff.
  • MOH staff involved in clinical trials are guided by the CRO’s Monitors in their conduct. Also some are sent for training programmes from  time to time to enhance their clinical skill (such as Study Nurses being trained in blood taking, ECG monitoring etc). This enhances the competency and skills of hospital staff, which are highly valuable in patient management.

In summary, there is currently very good ground laid out in Malaysia to carry out Industry Sponsored Research. There is strong support by the Government and CRM was set up to help in many aspects. However it all comes down to the Investigators – You are the leaders and decision makers on the  conduct of Clinical Trials, and you have the power to bring in all the benefits that Clinical Research offers to Malaysia.

Application to conduct clinical trial with a new investigational drug

What is the regulatory body that oversees clinical trials in Malaysia?

The National Pharmaceutical Control Bureau. The specific unit in charge within the Bureau is the Centre for Investigational New Product
www.bpfk.gov.my

How does a sponsor/CRO obtain approval from the regulatory body to conduct clinical research with a new investigational drug?

The SOPs and guidelines are available in the National Pharmaceutical Control Bureau’s website at http://portal.bpfk.gov.my/index.cfm?menuid=69.
A sponsor or CRO without an office in Malaysia can outsource this application service to any local or locally-based CROS/SMOs in Malaysia. CRM will international CROs that has no base in Malaysia, with local CROs so their trials can be conducted here.

What are the local CROs in Malaysia?

  • Info Kinetics Sdn Bhd
  • Klinsel Sdn Bhd
  • MySMO Sdn Bhd
  • Veras Research Sdn Bhd

What are the international CROs that are based in Malaysia?

  • Quintiles Sdn Bhd
  • PAREXEL International (Malaysia) Sdn Bhd
  • Covance Services Malaysia Sdn Bhd
  • INC Research
  • PharmaNet (Malaysia) Sdn Bhd
  • Pharmaceutical Product Development (M) Sdn. Bhd. (PPDI)
  • Novotech Clinical Research (M) Sdn Bhd
  • D2 Bio Solutions Sdn Bhd
  • Veeda Clinical Research SE Asia

What documents are required for the approval process?

The documents needed are as follows:

  • Clinical Trial Import License (CTIL) (form BPFK 442) or Clinical Trial Exemption (CTX) (form BPFK 443)
  • 2 copies of application submission form (form BPFK 001)
  • 2 copies of submission checklist (form BPFK 002.5)
  • Processing fee
  • Company registration certificate
  • Copy of applicant’s License A
  • Letter of Authorisation, if the application service is outsourced
  • Ethics approval letter
  • GCP certificate of each Site Investigator
  • GMP certificate/statement
  • Study protocol
  • Informed Consent form (initial version)
  • Pharmaceutical data and Investigator’s Brochure (IB).

Who is responsible for this application?

A representative from the sponsor or CRO such as a Clinical Research Associate. The application form must be signed by a Licence A holder for ‘poison/drug’. Holder of the CTIL/CTX need not necessarily be the one who conduct the trial.

How long is the approval process?

A complete application without queries can be approved within 30 working days.

Is there a fee for this clinical trial application?

Yes, the processing fee is approximately USD170 per product.

Application for the transport of biological specimen or sputum

Application for ethics approval

What are the ethics committees for approving clinical trials in Malaysia?

There are 13 such ethics committees. Clinical trials conducted at these site have to be approved by the respective ethics committees. The list is as follows:

1. Hospital Universiti Kebangsaan Malaysia (HUKM)
2. Hospital Universiti Sains Malaysia (HUSM)
3. Institute Jantung Negara (IJN)
4. International Medical University (IMU)
5. Joint Penang Independent Ethics Committee (JPEC)
6. Ministry of Health Medical Research and Ethics Committee (MREC)
7. Sime Darby Medical Centre (SDMC)
8. Sunway Medical Centre (SMC)
9. Universiti Islam Antarabangsa (UIA)
10. Universiti Teknologi MARA (UITM)
11. University Malaya Medical Centre (UMMC)
12. Universiti Putra Malaysia (UPM)
13. USM – Lam Wah Ee

The Ministry of Health Medical Research Ethics Committee (MOH MREC) handles applications for clinical trials conducted in all MOH hospital sites. This committee meets twice monthly. The schedule is available at www.nih.gov.my

What is the process to apply for MOH MREC's approval?

Applications can be submitted online through the National Medical Research Register (NMRR: www.nmrr.gov.my). The Principal Investigator and all sub-investigators must be registered with the NMRR. The CRA can do the registration for the Principal Investigator, who then can log in to change the password.

Are general SOP/guidelines/checklist/template available?

Yes, there is a guideline which can be downloaded from www.nmrr.gov.my.

Does the Informed Consent Form have to be in different languages?

Yes, it has to be in English, Bahasa Malaysia and Mandarin, and in Tamil where required.

How long is the approval process?

A complete submission without queries can be approved within 4 to 8 weeks

If you have any queries, please contact us at:

MOH Medical Research Ethics Committee (MOH MREC)
NIH Secretariat
Ministry of Health Malaysia
c/o Institute for Health Management
Jalan Rumah Sakit Bangsar
50900 Kuala Lumpur, MALAYSIA

Tel: +603 2282 9082/9085

Fax: +603 2287 4030

Email: nihsec@nih.gov.my

Website: www.nih.gov.my

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