This is an online, in person training course scheduled for Thursday 30th March 2023, (09.00 – 16.00) consisting of a 1 day course and a final assessment quiz.
The intent of the ISO14155:2020 standard training program is to provide crucial guidance and support to any party involved in the conduct of Clinical Investigations with human participants – Sponsors (including monitors) and investigators, but also includes ethic committees, regulatory authorities and notified bodies assessing the conformity assessment of medical devices.
The new version of the ISO standard aligns with the European Medical Device Regulation (EU MDR 2017.745), the ICH E6 (R2) guidelines n Good Clinical Practice and FDA guidance documents with a focus on medical devices. The updates ensures the standard is relevant and maintain acceptance by the global medical device industry. The focus of the updates is on the increasing demand to demonstrate safety and data reliability.
- Understand and apply the requirements of the ISO 14155:2020 as a GCP guidance to ensure practical implementation during the preparation, execution, and evaluation of clinical studies in medical devices.
- Understand how risk management is applied to all aspects of medical device clinical investigations.
- Understand the different types of clinical investigations, study design and how the ISO14155 requirements apply.
Patient safety, data integrity, practical approach, good documentation practices, site selection, communication and collaboration to deliver the clinical strategy.
Schedule 1: Scope of ISO14155:2020
Schedule 2: Ethical Considerations
Schedule 3: Clinical Investigation Planning
Schedule 4: Clinical Investigation Conduct
Schedule 5: Clinical Investigation Close-out
Schedule 6: Roles and Responsibilities of Sponsor (including monitoring)
Schedule 7: Roles and Responsibilities of Principle Investigator and clinical investigation staff
Workshops throughout the day
Final Quiz (80% pass rate)
The European Medical Device Regulation (MDR, EU 2017/745) increases clinical data requirements in support of safety and performance of medical devices and is likely to spark an increase in clinical investigations in Europe. In any stage of clinical development, from early feasibility studies to registries, GCP can and should be adhered to in order to ensure ethical and scientific conduct of the investigation and credibility of the results. We recommend complying with the ISO14155 standard in all medical device studies in humans, both pre-market and post-market.