The Protocol Support Unit (PSU) serves as a comprehensive and centralized resource for Stephenson Cancer Center (SCC) investigators interested in developing and conducting investigator-initiated trials (IITs). Current PSU services include:
- Consultation on Letters of Intent and clinical trial design
- Protocol development and writing
- Coordination with SCC Departments
- Project management
- Management of protocol revisions and amendments
- Protocol Data and Safety Monitoring Plan (DSMP) development
- Support for IND submissions
- Assistance with implementing operational processes related to the trial
- Serving as the primary point of contact between investigators and the FDA and/or drug companies
- Providing regulatory expertise in managing sites and clinical monitoring practices
- Coordinating data cleaning activities
- Budget and contract assistance
The PSU currently employs three fulltime protocol development specialists who manage multiple oncology IITs from initial concept and study start-up to study close out. The PSU also collaborates with the Clinical Trials Office’s regulatory specialists, IIT data managers, and clinical trial auditors.
The PSU has grown substantially since its inception in 2016 and now supports a large and growing portfolio of active and pending IITs, including both single- and multi-site trials.