Training on Good Clinical Practices

Training on Good Clinical PracticesProvide three-part, train-the-trainer training for China’s State Food and Drug Administration (SFDA) on good clinical practices (GCP) to enhance SFDA’s oversight of clinical trials in the region. In the first phase, FDA experts trained Chinese inspectors on FDA’s regulations and practices in the area of clinical practice; in the second phase, FDA experts supervised these same Chinese experts as they conducted mock inspections at clinical sites in China; in the third phase of the training, FDA experts will observe and assess these Chinese inspectors as they provide training for classrooms of other Chinese inspectors. Such training will help to enhance the capacity of Chinese investigators to conduct inspections of sites in China that conduct clinical trials for drugs and medical devices. This could help ensure the quality of clinical trial data, some of which are submitted to FDA in marketing applications.

OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.

COMPLETED

ON TRACK

A. Complete first phase of GCP training for SFDA inspectors

4/3/2010

Completed

4/16/2010

B. Agree on timing, content for second phase of GCP training for SFDA inspectors

12/10/2010

Completed

12/3/2010

C. Conduct second phase of GCP training (GCP-2)

3/15/2011

Completed

3/4/2011

D. Translation of mock inspection reports from GCP-2

4/30/2011

Completed

4/28/2011

E. Review of mock inspection reports from GCP-2

6/15/2011

Completed

6/3/2011

F. Evaluation of GCP-2

8/31/2011

Completed

6/30/2011

G. Agree on timing, content for final phase of GCP training

9/30/2011

Completed

9/30/2011

H. Conduct final phase of GCP training (1)

N/A

(1) Milestone was not completed while this project was tracked in FDA-TRACK.

http://www.fda.gov/AboutFDA/Transparency/track/ucm206185.htmFDA-TRACK Office of International Programs Dashboard