Clinical investigation of medical devices for human subjects — Good clinical practice (GCP for Medical Devices) has undergone a significant review.
The changes include;
— inclusion of a summary section of GCP principles
— reference to registration of the clinical investigation in a publicly accessible database
— inclusion of clinical quality management
— inclusion of risk-based monitoring
— inclusion of statistical considerations
— inclusion of guidance for ethics committees
— reinforcement of risk management throughout the process of a clinical investigation
— clarification of applicability of the requirements of this document to the different clinical development stages
— inclusion of guidance on clinical investigation audits
Never fear! Our team at PRAXIS are currently working with a team of Australian experts to bring you education resources to bring the #clinicaltrials sector up to speed on the new requirements.