Current CRU Issues in Planning and Executing Phase 1 Trials is a Master Series program delivered in two parts that can be taken as a set or individually, i.e., you are not required to attend both sessions. However, attendees are strongly encouraged to attend both sessions to maximize this learning opportunity.
(Part I is delivered immediately before Part II in a separate meeting room.)
Part I explores the features and potential issues related to conducting Phase 1 trials in a Clinical Research Unit (CRU), some of which are also found in later-phase trials. Learn of the variety of issues affecting researchers at the site and sponsor level, including evaluation of protocols for feasibility, telemetry, TQT studies, FIH trials, cost-saving measures for sponsors and audits.
(Part II is delivered immediately after Part I in a separate meeting room.)
Part II engages participants through interactive activities and discussion. Review draft proposals and gain insight into how to interpret and address abnormal findings. Work with two experienced investigators to address your questions and complete sample activities. Leave the session with new ideas to implement at your site.
Discuss potential issues related to conducting Phase 1 trials in a CRU
Review draft protocols and recognize potential issues
Interpret abnormal findings and develop a plan to address them