Application Procedure

New Application Procedure

  • Submit 13 copies (1 original and 12 photocopies =2 full dossiers+ 10 simplified dossiers) of the following supporting documents.

Application

  • Investigators that will conduct an interventional clinical trial should be trained and certified in an approved training of Good Clinical Practice (GCP) by the National Committee for Clinical Research (NCCR).
  • All new applications are to be submitted with a one-off application fee of RM2,000 per research project made payable to ‘Info Kinetics Sdn Bhd’. Application(s) will only be processed upon receipt of full payment.
  • It is the prerogative of JPEC to waive this fee for investigator-driven research, which does not receive funding.
  • Any incomplete applications will lead to a delay in review.
  • Applicants are required to register all research projects with the National Medical Research Register (NMRR) at https://www.nmrr.gov.my/fwbLoginPage.jsp. The full NMRR ID should be provided to JPEC for trials seeking approval from JPEC. No approval will be given without the NMRR ID.

 

 

Amendment Application Procedure

  • Complete the ‘Application for Amendment to Research Project involving Human Subjects(signed by PI or CI for multiple sites) form and submit one original copy with relevant supporting documents. For applications, that may affect subject safety, rights or welfare, the proposed amendments and study documents(s) with proposed amendments clearly indicated (tracked changes) and the rationale for the amendment needs to be submitted along the with the form.
  • These applications may either undergo an expedited review or a meeting review:

AmendmentApplication