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Application to conduct a clinical trial
Submit 10 sets (1 original and 9 photocopies) of the following forms:
Please provide any relevant supporting documents, e.g:
All new applications are to be submitted with a one-off application fee of RM 1,500 per research project made payable to RSD Hospitals Sdn Bhd – SJMC.
Submission criteria for clinical research
Researchers’ responsibilities from the World Health Organisation
Standards and operational guidance for ethics review of health-related research with human participants 2011
Research is performed only by persons with scientific, clinical, or other relevant qualifications appropriate to the project, who are familiar with the ethical standards applicable to their research, who submit the necessary information to the Research Ethics Committee (REC) for review (including both the research protocol and disclosures of any conflicting interests), and who carry out the research in compliance with the requirements established by the REC.
Review of new clinical trial applications
Applicants will be notified of the date and time of the IEC meeting (at least 7 days in advance) where the application is to be reviewed.
The investigator will be required to attend this meeting to present the research submission and answer queries from IEC members.
The Independent Ethics Committee
How to contact
The IEC Secretariat can be contacted at.