Clinical Trials

The Office of Clinical Research and Training (OCRT) was established in May 1997 to enhance and facilitate clinical research activities. Procedures, forms, and guidelines are currently being developed and will be available later in the year. In the interim, OSR will continue to receive and process clinical trial agreements. Components of a complete clinical trial agreement package include the draft agreement, approved protocol and consent form, proposed budget, name of the contact person in the sponsoring organization, and a completed OSR-1 form. OSR will begin negotiations if the package is not complete. However, a study may not be activated until the clinical trial agreement package is complete, including an endorsed agreement and an IRB-approved protocol and consent form.