Clinical Research Development Program Highlight

Many investigators work very hard in developing their Investigator Initiated Trial (IIT). They know the science and the question(s) they want to answer, but they are woefully unprepared for the project management elements (or sponsorship) that must be in place for trial compliance and success.    

The Clinical Research Development (CRD) team at The Ohio State University Center for Clinical and Translational Science (CCTS) is here to assist the investigator with the roles and responsibilities of sponsorship for an IIT. We can consult with investigators in the areas of finance, regulatory document management, continuous oversight, project management, muti-site management and data management. The lack of thoughtful planning in these areas can cause trials to be overspent, underperform, have poor data quality and potential non-compliance with funding agencies.  

Our team has over 25 years of experience managing multi-centered research endeavors. It is Directed by Amy Bartlett and Dr. Henry Wang, Emergency Medicine Research Director. We have created over 30 templates of assorted project management documents that we can provide to aid in the initiation and management of the research (examples: manual of procedure, data quality plan, data monitoring plan, recruitment tracking tool, protocol deviation management, corrective and preventative action monitoring (CAPA) and regulatory management files, pharmacy manual, sample case report forms, etc.). We can also assist investigators to find staffing or additional training for project managers.

The CRD team serves as a research concierge and links investigators with other resources/collaborations both on and off campus. Below is a sample of resources we have linked people to in the last month:

• Ohio State groups that excel in survey research (CHRR and RISSR)
• Trial Innovation Network provides free consultations for investigators to develop multi-centered studies aiding in budget development, grant review, recruitment and much more
• 21 CFR Compliant Databases 
• Link to a training video on how to use Workday and PI Portal for grants management 

The Clinical Research Development team is here to help navigate the complex world of creating a complete and compliant IIT and providing links to the resources to ensure success. You can reach the team by emailing amy.bartlett@osumc.edu to request a consultation.