The Association of Clinical Research Professionals
Investigator-Initiated Trial Tips and Tricks
The concept of the “site as sponsor” is becoming more common for clinical research conducted at academic institutions. This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges.
With intellectual ownership of study implementation, there are numerous tasks to consider: budget and invoicing, specimen collection, processing, and transport, data collection, IRB and consent documents, staff training, study monitoring, regulatory responsibilities, publication authorship agreements, and data use and management.
Areas overlooked within the planning phase in IITs can hinder swift execution of study deliverables and scientific progress. Included in this offering are effective, simple checklists and best practices for study start up and tracking study progress. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.
Upon completion of this continuing education program, participants should be able to:
Provide high-level view the various areas to consider when launching an Investigator Initiated Study (IIT).
Discuss specific considerations when site becomes the sponsor of an IIT.
Share best practices and useable worksheets for IIT assessment and management.
Samantha Sharpe, CCRP
Sr. Program Administrator – Clinical Genomics Research
Nationwide Children’s Hospital