Investigator initiated studies (IIS) are clinical studies initiated and managed by researchers independent from the industry, like individual investigators, institutions, collaborative study groups or cooperative groups. This course provides insight in how such studies differ from industry sponsored studies, and provides guidance on the regulations that apply for IIS and the level of involvement of the industry in such projects. Furthermore, the impact of the shift of sponsor responsibilities from the industry to the independent researcher will be discussed, along with the requirements for qualitative conduct and reporting of IIS.
By the end of this TRIUM Training you should be able to:
- Describe the main differences between IIS and industry sponsored studies
- List the GCP requirements and responsibilities for investigators performing IIS
- Define which activities and documents are required for IIS
- Explain ways on how to demonstrate an appropriate level of oversight
- Critically assess the challenges of conducting IIS
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.