新药临床试验期间药物警戒和风险控制研究二:临床试验方案、研究者手册和知情同意书监管要求研究

目的：对比临床试验期间国内外临床试验方案、研究者手册、知情同意书这三个关键要素中关于药物警戒监管的差异，为我国科学监管提出建议，从而加强新药临床试验期间安全性风险控制及受试者保护。方法：通过文献和法规研究，对比临床试验期间国内外临床试验方案、研究者手册、知情同意书这三个关键要素中关于药物警戒监管的差异，就如何更好应用临床试验方案、研究者手册、知情同意书保护受试者展开讨论。结果与结论：临床试验方案、研究者手册、知情同意书是临床研究中关于风险控制和受试者保护的关键安全性管理要素。我国临床试验期间上述三项管理要求的指导原则尚待完善，目前规定大多仅基于ICH的普遍要求，缺少基于国内行业现状的监管及指导。

Research II on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: A Study on Regulatory Requirements of Pharmacovigilance for Clinical Trial Protocols, Investigator's Brochure and Informed Consent Forms

Objective: To put forward suggestions for China''s scientifi c supervision in order to strengthen the risk control on safety and protection on subjects during clinical trials of new drugs after comparing the diff erences of pharmacovigilance supervision at home and abroad about the three key elements of clinical trial protocols, investigator''s brochure, and informed consent forms during clinical trials. Methods: Through literature search and reviews of regulations, the diff erences in domestic and foreign regulations on pharmacovigilance about thehree key elements of clinical trial protocols, investigator''s brochure and informed consent forms were compared. Discussions were conducted on how to better apply clinical trial protocols, investigator''s brochure and informed consent forms to protect subjects. Results and Conclusion: The clinical trial protocols, investigator''s brochure, and informed consent forms are the key safety management elements for risk control and protection on subjects in clinical trials. The guidelines for the above three management requirements during clinical trials in China need to be further improved. Most of the current regulations are formed only to meet the general requirements of ICH and there is a lack of supervisions and guidances consistent with the current situation of the domestic industries.