The Clinical Trials Office (CTO) will be responsible for the business management of any research studies designed to evaluate the safety and effectiveness of medical care that require IRB review ("Clinical Research").
CTO responsibilities for projects meeting the CTO definition include:
- Registry into CTMS
- Evaluation for billable items and services
- Medicare coverage analysis
- Budget development and negotiation (if applicable)
- Review patient care services
- Contract development and negotiation (if applicable)
Study intake form
This form must be submitted to the CTO along with the study protocol (in draft or final form). If you have additional documents related to the study, please include those as well.
Each investigator conducting a clinical trial must keep a binder(s) containing all study-related documentation pertaining to the trial.