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References

  1. The Canadian Institutes of Health Research (CIHR) and Queen’s University at Kingston. Module 8: REB review. In: TCPS 2: CORE (Course on Research Ethics) [Internet]. Government of Canada; Available from: https://tcps2core.ca/welcome
  2. Medical Research Ethics Committee. Research Ethics Application Form [Internet]. University of Malaya Medical Centre; 24 Aug 16. Available from: https://www.ummc.edu.my/files/ethic/NEW%20STUDY%20APPLICATION%20FORM_24Aug16.docx
  3. Medical Research Ethics Committee. Ethics Review Checklist [Internet]. University of Malaya Medical Centre; Available from: https://www.ummc.edu.my/files/ethic/UMMC-MREC%20Review%20Checklist.docx
  4. e-CFR (Revised Common Rule) [Internet]. United States Electronic Code of Federal Regulations. Sect. Part 46—Protection of Human Subjects Jul 19, 2018. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
  5. Medical Research Ethics Committee. SOP II: Initial review procedure [Internet]. University of Malaya Medical Centre; 2017. Available from: https://www.ummc.edu.my/files/ethic/II.%20INITIAL%20REVIEW%20PROCEDURE.pdf
  6. Medical Research and Ethics Committee (MREC). Quorum of Meeting [Internet]. [cited 2019 Mar 7]. Available from: http://www.nih.gov.my/mrec/quorum-of-meeting/
  7. Tebbutt S. Guidance for Applicants attending a Full REC meeting [Internet]. NHS Health Research Authority; 2016. Available from: https://www.hra.nhs.uk/documents/21/2016-guidance-applicants-attending-rec-meeting.pdf
  8. Preparing for the meeting [Internet]. The Research Ethics Guidebook. [cited 2019 Mar 7]. Available from: http://www.ethicsguidebook.ac.uk/Preparing-for-the-meeting-200
  9. Attending a REC meeting [Internet]. NHS Health Research Authority. 2018 [cited 2019 Mar 7]. Available from: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/research-ethics-committee-review/applying-research-ethics-committee/attending-rec-meeting/
  10. U.S. Department of Health and Human Services. Part 2 – Balancing Society’s Mandates: I.R.B. Review Criteria [Internet]. 2018. Available from: https://www.youtube.com/watch?v=Ec1BqLP7ZUQ
  11. 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
  12. Medical Device Authority (MDA). MDA/GD/0006 Definition of medical device (First edition) [Internet]. Ministry of Health Malaysia; 2014. Available from: https://portal.mda.gov.my/documents/guidance-documents/803-6-def-of-md/file.html
  13. 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
  14. Ministry of Health Malaysia (MOH) Medical Research and Ethics Committee. MREC Amendment application form [Internet]. National Medical Research Register; 2016. Available from: https://nmrr.gov.my/doc/Amendment_Application_Form.docx
  15. 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
  16. Ministry of Health Malaysia (MOH) Medical Research and Ethics Committee. MREC Protocol Deviation or Violation Report [Internet]. National Medical Research Register; Available from: https://nmrr.gov.my/doc/MREC%20Protocol%20Deviation%20&%20Violation%20Report.docx
  17. Module 2 - Research Protocol. In: Johns Hopkins Bloomberg School of Public Health - GCP – Social and Behavioral Research Best Practices for Clinical Research [Internet]. CITI program; Available from: https://www.citiprogram.org/index.cfm?pageID=14&languagePreference=English&region=1
  18. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting: ICH E2A [Internet]. [cited 2019 Jan 22]. Available from: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-definitions-and-standards-for-expedited-reporting.html
  19. MEDDEV 2.7/3 revision 3 Guidelines on medical devices - Clinical investigations: Serious adverse event reporting under directives 90/385/EEC and 93/42/EEC [Internet]. European Commission; 2015. Available from: https://ec.europa.eu/docsroom/documents/16477/attachments/1/translations
  20. National Pharmaceutical Control Bureau. Malaysian Guideline for Safety Reporting of Investigational Products (First edition) [Internet]. Ministry of Health Malaysia; 2014. Available from: http://www.nccr.gov.my/index.cfm?menuid=49&parentid=17
  21. CIOMS Form [Internet]. The Council for International Organizations of Medical Sciences; Available from: https://cioms.ch/wp-content/uploads/2018/09/CIOMS-to-E2B-1.pdf
  22. Ministry of Health Malaysia (MOH) Medical Research and Ethics Committee. MREC Continuing Review Form [Internet]. National Medical Research Register; 2016. Available from: https://nmrr.gov.my/doc/Continuing_Review_Form_Version2.docx
  23. 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
  24. Center for Devices and Radiological Health. Preparing for a Clinical Investigator Inspection [Internet]. U.S. Food and Drug Administration; 2012. Available from: https://www.fda.gov/downloads/Training/CDRHLearn/UCM293102.pdf
  25. National Pharmaceutical Regulatory Agency. Malaysian Guideline for Good Clinical Practice (GCP) Inspection 2nd edition [Internet]. Ministry of Health Malaysia; 2018. Available from: http://www.npra.gov.my/images/Guidelines_Central/Guidelines_on_Clinical_Trial/NPCBGUIDELINESFORGCPINPECTIONINMSIAFINAL20818.pdf
  26. Secretariat for National Committee for Clinical Research, Ministry of Health Malaysia. Malaysian Guideline on the use of Human Biological Samples for Research [Internet]. Ministry of Health Malaysia; 2015. Available from: http://www.crc.gov.my/wp-content/uploads/2016/07/Guideline_on_Human_Tissue_in_Clinical_Research.pdf