The prerequisite for evaluation of the effectiveness and safety of medical devices is to ensure the authenticity and integrity of clinical trial data.  The clinical trial data management refers to the case report form (CRF) design, data collection, on-site verification and quality control through the whole process of the trial. Upon release of the China Food and Drug Administration (CFDA) Good Clinical Practice for Medical Device Clinical Trials, how to implement the data management normatively (Good Data Management Practice) to make it meet the supervision requirement for clinical trials will be the new challenge for medical device enterprises under the new situation.

To cope with this new challenge and help these enterprises implement data management normatively so as to meet the supervision requirement for clinical trials, China Association for Medical Devices Industry (CAMDI) Medical Data Analysis Committee held a seminar for medical device clinical trial regulations, data management and on-site verification in Suzhou on April 15-16.

Experts

During the seminar, experts from CFDA, BFDA, JSFDA, Medical Research & Biometrics Center of National Center for Cardiovascular Disease (MRBC-NCCD) made deep explanation on the principle and management procedure of CFDA medical device clinical trial supervision laws & regulations, data management standard, data management process, and how to implement normative data management and supervision process in the enterprises. They analyzed with practical cases, the trainees benefited a lot from which.

On-site Communication

The hot and sufficient on-site communication and interaction brought new understanding to the trainees from theory to practice. In addition, after this training, the conference affairs team created a WeChat group for interaction and comments between trainees and teachers to maximize the digestion of training content for the trainees.

The medical device clinical trial regulations, data management and on-site verification seminar is part of the series seminars on medical device clinical trial regulations, trial design, data management, on-site inspection, and statistical analysis by China Association for Medical Devices Industry (CAMDI) Medical Data Analysis Committee. It is a seminar for domestic and overseas medical device enterprises with final purpose of grasping practical operation skill.

As the first session of the CAMDI series seminars, this seminar gained unanimous praise from the trainees. Please continue to follow the CAMDI series seminars.