Investigator Initiated Studies (IIS) are crucial for new product development. These Investigator initiated studies represent new challenges for the Investigators and their team. Indeed, managing a Clinical Trial as sponsor is outside of their day-to-day work. This training programme is intended to help them understanding how to implement mandatory Clinical Studies rules for sponsor in practice in order to ensure patient safety and data quality and overcome all challenges associated to it. If you want to have a clear overview of the IIS set-up and management specificities, then this course is for you!
A large proportion of clinical Studies are conducted by (non-commercial) sponsor-investigators. Non-commercial sponsor-investigators rely on funding which comes partly or entirely from public funds or charities. These limited resources (team and fund) represent challenges and specificities in the Clinical Trial implementation and management. Moreover, being a sponsor is asking to understand the difference between an investigator and a sponsor in term of responsibilities and requirements. ECCRT developed this course in order to help them to maximise their valuable contribution as non-commercial sponsors without compromising the quality of clinical Studies. This course is covering how to set-up and how to manage a clinical trial in this specific context at all operational level e.g. data management, budget management, monitoring, safety, quality etc. After this course attendees will have a clear understanding about the challenges it represents to implement a study as a sponsor-investigator and how to overcome them in order to ensure patient safety and data quality as requested by ICH-GCP. This course will allow attendees as well to share their experience and questions with their peers, trainers and one field expert.
Find out more in our flyer: IIS flyer.