Neala Lane, MS, CCRC, Associate Director of Quality Improvement at Indiana University will present ‘Integrating Quality into Investigator-Initiated Clinical Trials’.

Successfully managing investigator-initiated trials (IITs) can be difficult for sites, in part because sites may lack the resources and support available to them in their industry sponsored counterpart trials. Key areas of difficulty in IITs include project feasibility, protocol development, data collection/data management procedure planning, and ongoing monitoring for data and safety issues. These activities are crucial for every clinical trial, but can seem daunting to the investigator and members of the IIT study team. This session will help study teams identify and manage potential pitfalls in their next IIT.

Session Learning Objectives:
1 - Identify quality standards, and areas of risk, for clinical trials.
2 - Describe measures to incorporate quality into study design and initiation of IITs.
3 - Examine ways to assess quality during IIT study conduct

*Registration Required