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Definition of clinical trials qualifying for CTO support

The CTO will be responsible for the business management of any research study that is designed to evaluate the safety and effectiveness of medical care and that requires full board or expedited IRB review ("Clinical Research"). Exceptions: unfunded registry studies, medical chart reviews, data and tissue repositories, and studies originating from certain non-clinical departments/divisions of Dartmouth College, including Arts & Sciences,Thayer School of Engineering,and Tuck School of Business.

(Thayer School of Engineering Specific Exception: Clinical research in collaboration with Dartmouth-Hitchcock (D-H) principal investigator and/or clinical research procedures that would have D-H patient billing implications.)

For projects that meet the CTO Clinical Trials definition above, the CTO responsibilities include:

  • Evaluation of the study for billable items and services
  • Medicare coverage analysis
  • Budget development and negotiation
  • Post-award financial management and reporting (industry-funded studies only)

NOTE: All clinical research studies (funded and unfunded) performed at Dartmouth must be registered in the CTO's Velos clinical trials management system by completing the intake form.

Study type Description MCA required Budget required
Industry Sponsored Pharmaceutical companies initiating the study and providing funding Yes Yes
Federally Sponsored Government initiating the study and providing funding. Example:NIH Yes Yes
PI Initiated Principal Investigator initiates the study and funding is provided by their department or grant Yes Yes
Cooperative Group A group of Medical Institutions cooperating to perform clinical research and providing funding Yes Yes
Registry Study Organized so the data can be analyzed *Yes *Yes
Foundations Foundation initiates study and funding. example: March of dimes Yes Yes

*If there are blood draws, subjects being seen, mailing results off site. Even if everything is Standard of Care, a MCA limited tab review is still required for bill review purposes

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