Clinical Trials Office

Safe and efficient conduct of adult trials

The mission of the IU Simon Comprehensive Cancer Center Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource to facilitate the development, completion and management of oncology clinical trials at IU Simon Comprehensive Cancer Center.

The CTO provides a comprehensive range of services, including:

• Protocol management, screening, monitoring, treatment administration, and reporting of adverse events.
• Coordinates the scientific review (SRC) of proposed trials.
• Assist in protocol development including IND/IDE management.
• Initial and ongoing preparation of regulatory documents for submission to the IRB and other appropriate agencies.
• Data collection and management.
• Budget preparation and negotiation.
• Investigator-initiated multicenter network.

The experienced CTO support staff enable the clinical investigator to efficiently conduct clinical trials in an increasingly complex regulatory and financial environment. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up.

Available services

The CTO provides a comprehensive range of services, including:

• Facilitating the review of clinical research protocols for scientific merit by the Scientific Review Committee
• Providing comprehensive clinical trials management services to clinical investigators of the cancer center for protocol development and conduct
• Internal auditing for the Data and Safety Monitoring Committee (DSMC), Education, Quality Program Manager and the IUSCC affiliate network
• Providing administrative support and supervised audit staff for the Data Safety Monitoring Committee
• Facilitating appropriate integration of the Biostatistics and Data Management Core into all aspects of the development, conduct and analysis of clinical trials
• Integrating and maintaining databases for registration and tracking subjects on clinical trials and migration of the data into a single IUSCC database called OnCore
• Maintaining protocols, consents and eligibility checklists in OnCore and the Study Information Portal (SIP) console

Research Resources (IU Login Required)

Protocol Development

Protocol Development serves to aid Investigators in taking ideas and making them a reality by assisting in writing, co-writing, editing protocols, creating necessary study documents, submitting to local and federal agencies on their behalf, and helping to manage the life of their trial.

Levels of service

• Level 1 Basic (ex. retrospective, non-CTO, non-therapeutic studies, observational studies) average 2-6 weeks
• Level 2 Moderate (ex. correlative studies, non-drug interventional studies, radiation oncology studies etc.) average 6-8 weeks
• Level 3 High (ex. phase 1, therapeutic trials that require an IND, multicenter studies etc.) average 8-12 weeks

Protocol Development RequestLevels of Service Documentation

Policies and procedures

The most current Data Safety Monitoring Plan, as well as SRC submission documents and information, are available from the IU Office of Research Administration.

If you are unable to access this site or have questions, please e-mail crosrc@iu.edu for more information.