Effective January 1, 2007 proposal review and award management of sponsored activities/research that meet the operational definition of a clinical trial (provided below), and/or for which the project will use the clinical services/resources or facilities of an external entity/health care provider (e.g. Norton Healthcare, Jewish & St. Mary’s, University Hospital, VAMC) will be handled by the Clinical Research Division of the Office of Industry Contracts. The primary change in this new policy is that clinical trial proposals and awards that are funded by federal and non-profit agencies and were therefore previously handled by the Office of Grants Management, will now be handled by the Office of Industry Contracts, located in Suite 200 of MedCenter One, at the corner of Broadway and Jackson.

OPERATIONAL DEFINITION OF A CLINICAL TRIAL FOR THE PURPOSE OF PROPOSAL SUBMISSION AND AWARD MANAGEMENT:

Study in which human subjects are assigned to a group that receives a clinical/medical intervention (e.g. medication, clinical/medical procedure, device) and/or a control group for a clinical condition and who interact with study personnel, having provided an informed consent.

• Clinical condition - symptom, set of symptoms or a diagnosis as determined by a qualified investigator

• Note: Consenting to the use of a biological fluid or tissue sample only for subsequent study does not constitute a clinical trial as there is no ongoing interaction between the investigator/study personnel and the human subject

The new PCF/MIRA along with instructions  are currently available on the EVPR website and should be used for all proposals submitted as of January 1, 2007. If you have questions please feel free to contact Dave King at 852-8359 or Judy Bristow at 852-3788. We are also available via email.