China is imposing strict requirements for records retention and strengthening responsibilities of sponsors as part of an update to good clinical practices for medical devices.
The China Food and Drug Administration and National Health and Family Planning Commission jointly issued the GCP update late last month. The document — which goes into effect June 1 — marks the first revision to the rules in more than a decade.
The update covers a number of trial-related topics, including preparation, protocol, protection of subjects’ rights, management of source documents, as well as the responsibilities of ethics committees, sponsors and investigators.
The new rules stipulate that sites must keep all clinical data and materials for 10 years after study completion. Sponsors must keep study records until devices are no longer in use, Katherine Wang, a partner with Ropes & Gray in Shanghai, says.
Wang says the document also clarifies that the study sponsor must be a device manufacturer, and international devicemakers must designate a Chinese company as an agent.
Sponsors also will be required to appoint qualified people to perform monitoring activities. If any information affects the study, the sponsor must revise the investigator brochure and obtain approval from the ethics committee.
Wang adds that revised informed consent forms must be approved by the ethics committee prior to communication with study subjects. In addition, the document specifies that a multicenter study is conducted according to a single protocol but at more than three sites. The principal investigator at the lead site will become the coordinating investigator.