The Committee shall

(a) regularly review and advise the Authority on the clinical trials system in the country and make recommendations regarding its maintenance and improvement;

(b) perform causality assessment and issue reports on adverse event in relation to clinical trials;

(c) make recommendations to the Authority regarding actions the Authority may take to resolve issues or concerns related to the conduct of clinical trials including the need to halt or suspend a clinical trial;

(d) recommend publication of case reports, as well as its risk or benefit evaluations in medical and scientific journals with prior consent of the sponsor;

(e) recommend educational programmes and topics for investigators aimed at enhancing reporting of adverse effect or event and improving compliance with Good Clinical Practice as recommended by the International Conference on Harmonization Guidelines and Helsinki Declaration;

(f) advise the Authority periodically on the review of guidelines for clinical trials and Good Clinical Practice issued by the Authority;

(g) advise the Authority on clinical end points in the review of protocols submitted to the Authority;

(h) recommend to the Authority approval of clinical trials;

(i) evaluate final reports of clinical trials that have been approved by the Authority;

 (j) advise the Authority on matters relating to inspections conducted by the Authority on Good Clinical Practice and Good Laboratory Practice; and

(k) perform any other functions that are ancillary to the attainment of the object of the Committee.