Office of Sponsored Programs
The Ohio State University

Clinical Trials

Clinical trials are studies of the effectiveness and safety of drugs, devices or procedures for the treatment of health problems in humans. Pharmaceutical or medical device companies conduct trials to develop new medical treatments that must first be approved by the FDA before they may be sold for use by patients.

For the purposes of establishing an agreement, clinical trials will be categorized as follows:

  • Sponsor Initiated – the protocol for the clinical trial has been written by the sponsor (a pharmaceutical or medical device company)
  • PI Initiated – the protocol was written by an investigator

Contract negotiations for clinical trials can be difficult and complex. In addition to the customary terms and conditions of a research agreement, a clinical trial agreement will also address various regulatory compliance issues as well as those dealing with subject safety. The sponsor may also hire a clinical research organization (CRO) to manage their contractual process. As a result, negotiations can take additional time to reach mutually acceptable terms.

Principal Investigators and/or the appropriate clinical trials management office should advise the Sponsored Program Officer responsible for the forthcoming project as early in the process as possible. The following information should be provided to the Sponsored Program Officer to ensure appropriate terms and conditions are obtained:

  • Provide a copy of the protocol and advise whether it was created by the sponsor or by an Ohio State investigator
  • Advise if a Confidential Disclosure Agreement (CDA) was completed in collaboration with OIED
  • Advise if a Material Transfer Agreement (MTA) was completed in collaboration with OIED
  • Advise if existing Ohio State intellectual property will be used in the project

The Clinical Trials Workflow outlines the steps involved in establishing a clinical trial project.