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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.
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