Question:
请问在什么情况下,受试者在撤销知情的时候,还需要做生存随访?
Answer:
终止知情同意之后,所有临床研究相关的操作均需要结束。如果患者仅仅是终止治疗,之后的随访,如方案要求的随访、SAE随访,等,应该在知情同意书中明确说明,征询受试者同意后方可收集。可以参考的法规是:
• FDA Informed Consent Information Sheet, Guidance for IRBs, Clinical Investigators, and Sponsors
• FDA 21 CFR 213.62 (b) & 812.40(a)
• FDA Guidance for sponsors, clinical investigators, and IRBs--data retention when subjects withdraw from FDA-regulated clinical trials: Oct 2008