The Clinical & Translational Science Institute of Southeast Wisconsin (CTSI) is pleased to announce a revised Clinical Trialist 101 course addressing practical aspects of clinical trials implementation and management. This single session 2-hour course will focus on successful implementation of Pharma sponsored clinical trials and will be offered in-person only.
Clinical or basic science faculty, advanced practice providers, or nurse scientists interested in starting, leading, or participating in industry funded clinical trials. This course will provide a practical overview of the processes involved in pharma/industry sponsored clinical trials implementation and the roles and responsibilities of study PIs and staff.
Overview of Topics
The course will describe various stages of implementing a clinical trial at MCW and the partner hospital systems with focus on the principal or co-investigator roles and responsibilities. There will be a special focus on how to initiate drug or device clinical trials addressing topics such as Confidentiality Disclosure Agreement, study initiation, contract management, budget development and negotiations, coverage analysis, patient enrollment, financial and regulatory management. Throughout the presentations, attendees will have the opportunity to learn more about institutional resources offered by the CTSI and Office of Research such as the Adult Translational Research Unit (A-TRU), Pediatric Research Unit (P-TRU), OnCore and Florence eBinders training, and trial support through the Clinical Trials Office (CTO).
NIH Funding Acknowledgment:Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.
