At the completion of your study, you should submit a summary of your research outcomes to the ethics committee. The report will be subjected to either an expedited (delegated) or a full board review, depending on whether there are any outstanding concerns about your study.
When there are unresolved issues, the committee may ask you for clarification or take further actions such as conducting a site inspection. Otherwise, your study will be classified as inactive and all the documents you have previously submitted will be archived for a number of years before they are disposed as confidential wastes. (15,23)
The NPRA and MDA require all investigational products to be carefully accounted for. At the end of a study, any unused products should be retrieved from subjects and returned to the manufacturer, or disposed securely. (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
Ministry of Health Malaysia (MOH) Medical Research and Ethics Committee. MREC Study Final Report Form [Internet]. National Medical Research Register; 2016. Available from: https://nmrr.gov.my/doc/StudyFinalReport%20Form.docx
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