You may have initiated the study termination yourself, or be instructed to do so by your sponsor or a regulatory authority. This could be due to different reasons such as safety concerns or achievement of significant findings after conducting interim analyses.
Your report should mention the reasons for early study termination and include any supporting documents.
The report may be subjected to an expedited (delegated) review or a full board review. The committee will take into account any risks to research subjects if your study is halted suddenly. They may require that you put in continued protection for subjects and provide clear information to subjects about post-study arrangements. (15)
Early termination of drug trials and medical device research should also be notified to the NPRA and MDA respectively. (11,13)
Medical Research Ethics Committee. SOP III: Post approval review [Internet]. University of Malaya Medical Centre; 2017. Available from: https://www.ummc.edu.my/files/ethic/III.%20POST%20APPROVAL%20REVIEW%20revisedlatestnov18.pdf
National Pharmaceutical Regulatory Agency. Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption Edition 6.4 [Internet]. Ministry of Health Malaysia; 2017. Available from: http://www.npra.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/CTILCTXGuidelineEdn64updated07082017cleanTSC.pdf
Medical Device Authority (MDA). MDA/GD/0016 Notification of exemption from registration of medical devices for the purpose of clinical research or performance evaluation (First edition) [Internet]. Ministry of Health Malaysia; 2017. Available from: https://portal.mda.gov.my/documents/guidance-documents/807-16-notification-for-clinical-research-or-performance-evaluation/file.html