What are the expectation of NMRR when I submit my document?
All information listed and documents submited are required to be complete, original and adequate for registration and submission to relevent authority. Any incomplete submission can lead to the delay of processing time and investigator or main/backup corresponding person will be required to revise the submisison.
How is my study being reviewed during Registration ?
Study submited for registration will be reviewed by NMRR Secretariat for completeness of information and the documents required. If study submisison has other purpose of submission listed during registration, submission will be then forwarded to relevent authority for further processing right after NMRR ID is issued and study submisison has been successfully registered.Main Corresponsing Person(CP) and Backup CP will receive and email to notify a successful registration with a unique NMRR ID as well as notification that the submisison has been fowarded to relevent authority for further proccessing (if any).
How many types of review are there in Scientific Review & Ethical Approval Submission?
According the assement that will be made by the respective secretariat, a submission will either undergo a JPP-NIH review , JPP-CRC /HRRC review or straight for MREC review . Submission undergoing JPP-NIH and JPP-CRC/HRRC review will be then forwarded next to MREC for furhter review and processing. For a detailed and more information , please kindly refer to the flowchart available in the documents section ( User Manuals)
How do I know if my study need to be registered in NMRR?
All medical & health -related research are invited to register in NMRR. As for now, it is compulsory for all clinical trial conducted in Malaysia to register their clinical trial prospectively with NMRR (requirement by the National Pharmaceutical Regulatory Agency (NPRA) for clinical trial requiring CTIL/CTX licences). Also registration in NMRR is required for all research related to Ministry of Health (undertaken by Ministry of Health (MOH) personnel or conducted in MOH facilities or using MOH data/patient/personnel as subject or funded by an MOH Research Grant) as stated in NIH Guidelines For Conducting Research in Ministry of Health Institutions & Facilities
Is it necessary to report a SAE/ SUSAR occurring in another protocol/ clinical trial using the same Investigational Product (IP)?
Currently, the MREC still does not have the necessary expertise to conduct pharmacoepidemiologic assessments, which involve detecting safety signals from different clinical studies that use the same investigational products. Therefore, line-listings of serious adverse reactions during the reporting periods in clinical trials are not necessary to be submitted to the MREC.