Table 1

List of laws and regulations reviewed to develop the Good Clinical Practice inspection checklist

Document titleVietnamese titleAccess linkNote
Legal documents in support of developing the checklist
Decision N\no. 779/QĐ-BYT on releasing guideline on ‘Good Clinical Practice’Quyết định số 779/QĐ-BYT về việc ban hành ‘Hướng dẫn thực hành tốt thử thuốc trên lâm sàng’http://asttmoh.vn/document_cat/van-ban-phap-quy-2/The development of the checklist was not fully compliant with these documents since they were released many years ago. It was also based on the draft version of Circular no. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs, which was made in December 2016.
Vietnamese
Circular no. 03/2012/TT-BYT on guiding clinical trials on medicationsThông tư 03/2012/TT-BYT Hướng dẫn về Thử thuốc trên lâm sànghttp://vbpl.vn/boyte/Pages/vbpq-van-ban-goc.aspx?ItemID=27303
Official dispactch no. 6586/BYT-K2ĐT on defining and reporting of SAEs in clinical trialsCông văn 6586/BYT-K2ĐT Hướng dẫn báo cáo, ghi nhận SAE trong TNLShttp://asttmoh.vn/wp-content/uploads/2014/12/Bao-cao-SAE.pdfSimilar to above, the development of the checklist was also based on the draft version of Decision No. 62/QĐ-K2ĐT on guiding detecting, managing and reporting AE, SAE in clinical trials, which was made in Octorber 2016.
Vietnamese
Legal documents reviewed after the development of the checklist
Law no. 40/2009/QH12 on medical examination and treatmentLuật Khám chữa bệnh 2009 (Luật số 40/2009/QH12)https://kcb.vn/vanban/luat-kham-benh-chua-benh-2Vietnamese
Law no. 105/2016/QH13 on pharmacyLuật Dược 2016 (Luật số 105/2016/QH13)http://extwprlegs1.fao.org/docs/pdf/vie178850.pdfEnglish (unofficial)
Decision no. 111/QĐ-BYT on the organisation and operation of local IRBQuyết định số 111/QĐ-BYT về việc ban hành Quy chế Tổ chức và hoạt đồng của Hội đồng đạo đức trong nghiên cứu y sinh học cấp cơ sởhttp://asttmoh.vn/wp-content/uploads/2014/12/Q-111-v_-quy-ch_-ho_t-_ng-c_a-IRB.pdfVietnamese
  • IRB, Institutional Review Board.