Does the NMRR meet international requirements for a Trial Registry?
The NMRR is yet to be a recognised as a Primary Registry in the World Health Organisation International Clinical Trials Registry Platform (ICTRP) Registry Network or recognised by the International Committee of Medical Journal Editors (ICMJE). An application for recognition will be made to the WHO as the NMRR Version 2 believes it complies with all the specified international requirements.
When is NMRR likely to be compulsory?
NMRR is the preferred system for applying to the review bodies including MREC (for ethical approval) , for MOH Research Grant (MOH) and for the Publication and Presentation Approval by the Director General of Health . NIH Guidelines For Conducting Research in Ministry of Health Institutions & Facilities states that 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) shall require registration in NMRR
Must all principal investigators and sub-investigators register with NMRR?
For ethical approval submission to MREC and based on the requirement of Malaysian Good Clinical Practice (MGCP), all principal investigators and sub-investigators involved in a study team must be reviewed by the MREC . Therefore it is a requirement to all the study team to register in the NMRR.
Does the investigator or sponsor need to register with NMRR?
Yes. All members of the research project should register stating their roles. Sponsor are adviced to register as sponsor representative in NMRR where the updates and process of submission and decision by relevent authority can be notified.
If my supervisor did not register, may I register for them?
You have to get him/her registered. You can do it for him/her if you have his/her email address, IC and other relevant information and document required for registration ; with your supervisor’s permission. He/She will get an email notification and password from the system and he/she can then update his/her user information as well as change the password. However it is advisable for all investigatorto register with NMRR by themselve to prevent any data leaked and missused. NMRR will not be reponsible for any of data leaking and mishap prior to the registration