1	Clinical Research: APOM Departmental Process Cindee Gray Research Administrator
2	Difference Types of Clinical Research Non-Funded Investigator Initiated Research Funded Industry Sponsored Clinical Trial
3	Things to Consider There are three areas to consider: Scientific Validity – is this study worth doing? Good subject to pursue? 2. Protocol/IRB Validity – is OHSU able to carry out the protocol, do we have the resources, use of GCRC, available staff, etc? 3. Financial Validity – Will we cover our costs and end with a net margin?
4	Non-Funded Investigator Research Starts with a Research Interest or Idea First Step: Meet with a scientific mentor, ie, Dr. Hurn, Dr. Palermo, to talk about the scientific validity Second Step: Assess the needs of the Research; if need to collect data or process a survey etc., with no costs, then step 3 is the next process. If there are costs involved, ie use of GCRC etc., then need to meet with Cindee Gray to determine what costs are & how costs will be funded before you can go on to the third step
5	Non-Funded Investigator Research As the Research Clinical Coordinator, Lori Kelly is the expert in specific Research procedures, ie., the IRB process, use of GCRC, pharmacy etc. Cindee may send you to Lori for advise in these areas. Third Step: ppq and eIRB submission process: Send ppq and protocol to Cindee for review. She will get signatures and approval and send directly to the IRB. Cindee keeps a file on all Research Projects.
6	Industry Sponsored Clinical Trials Industry Sponsor has been in touch with you and has approved our site for their trial First Step: Meet with Scientific Mentor, someone who can help you with the validity of the study… is this something worth pursuing, good study to do, subject recruitment availability, etc. Second Step: Must have the Sponsor Protocol and Budget. Cannot proceed with departmental approval until you have received not only the protocol, but the budget. Third Step: Contact Cindee Gray to assess the Research needs of the trial. At this point, Lori Kelly will be contacted to help identify and advise on protocol validity, IRB issues, identify Research costs involved, ie GCRC, Pharmacy costs, etc.
7	Industry Sponsored Clinical Trials – continued Fourth Step: Once Cindee has all the information ie; PI time, RA time, costs involved etc. she will process an internal projection. This will test the Sponsor Budget to see if this trial is financially viable. At point, a ppq will need to be processed and sent to Cindee for review Fifth Step: Cindee will go over the internal projection with the PI and then present it, along with the ppq and protocol to Vice-Chair Research for Approval. Last Step: Once all the negotiation is done with the sponsor, the contract will need to be signed and IRB submission can begin.
8	Projections/ Budget Industry Sponsor must cover all costs associated with the clinical trial. PI time, RA time & Administrator time IRB fees, Pharmacy fees, supplies, subject reimbursement, advertising/recruitment costs etc. - Residual Goal of 10% of Trial
9	Questions?