FAQ
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)?
 |  |
|---|---|
| Previously a unit under CRC, but was corporatized in 2012 | Formed since 2000 |
| Facilitates Industry Sponsor Research (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 |
Application to conduct clinical trial with a new investigational drug
What is the regulatory body that oversees clinical trials in Malaysia?
How does a sponsor/CRO obtain approval from the regulatory body to conduct clinical research with a new investigational drug?
What are the local CROs in Malaysia?
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
- George Clinical
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?
How long is the approval process?
Is there a fee for this clinical trial application?
Application for the transport of biological specimen or sputum
Are there any specific regulations pertaining to 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?
Are general SOP/guidelines/checklist/template available?
Can hardcopy documents be submitted to the MOH MREC if the sponsor does not allow online submission for certain study documents, for example the IB?
Does the Informed Consent Form have to be in different languages?
How do we add a new clinical trial site, protocol amendment, additional study documents and other documents after MOH MREC's approval?
How long is the approval process?
Is there a fee for the Ethics Committee review process?
Legal Department
What is the main functions for CRM Legal Department?
What is the turn over time for CTA review by CRM Legal?
Is there any fee impose by CRM relating to CTA review?
Yes. For ISR and IIR Hybrid, we are charging RM4000.00 regardless of how many MOH sites involved in the study.
And for BABE study the legal review fee is RM2000.
*The legal review fee is per protocol basis and is a one-off payment.
Is there any legal review fee for CTA amendment?
No. The legal review fee is a one-off payment.
Do CRM Legal review the CTA for non-MOH site?
For more information, please contact CRM Legal at +603 7960 5153 (Ext: 126/127)
Finance Department
What is the main functions for CRM Finance Department?
- To enable the transparent management of funds for Ministry of Health staffs.
What is the turn over time for Study Budget review by CRM Finance?
