Question: ArrayIf the applicant adopts a fully outsourced clinical trial approach, how should this clause (30) be understood? (GCP No. 57 of 2020, Article 30) @ @ If it is all outsourced, according to Article 33 of the new version of the Chinese GCP, "the applicant shall still be the ultimate responsible person for the quality and reliability of clinical trial data, and shall supervise the various tasks undertaken by the contract research organization. From the perspective of quality management system, applicants should clarify the responsibilities of all parties, equip qualified personnel, establish appropriate processes, carry out risk based quality management, problem management, etc., to ensure the supervision of clinical trials by applicants.
Answer:
如果是全部外包,依据新版中国GCP 第三十三条,“申办者仍然是临床试验数据质量和可靠性的最终责任人,应当监督合同研究组织承担的各项工作” 。从质量管理体系角度,申办者应明确各方职责,配备合格人员,建立适当流程,开展基于风险的质量管理,问题管理等,确保申办者对临床试验的监督。