Creating PI-initiated Industry funded Clinical Trial EPD records: Points to remember A UC Investigator authored the study protocol: Anticipated Award Type : PI-Initiated Clinical Trial Activity Type : Clinical Research Deadline date: Should be 6 months from the date the record is created 6 mos. out is the numerical equivalent to “internal” This indicates to the office that there is no hard deadline noted in a formal solicitation IDC: 30% TDC (total direct costs) is appropriate for clinical studies that fit the definition of a Clinical Trial for IDC purposes: Solely for purposes of indirect cost (IDC) calculation, a study is considered a clinical trial when it contemplates the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Questionnaire: Administrative-Clinical Trial: Answers should match anticipated award Type. Ex. If it’s a PI-initiated Clinical Trial, the Sponsor should not have provided the protocol Abstract Tab: Internal Comments: Use this to provide your Officer details or specific information regarding the study or EPD record Upload Attachments: At minimum always include: 1. OCGA internal budget sheet 2. Research Plan/SOW 3. “Complete Proposal Application”= 1+2 in a single pdf doc. UC San Diego- OCGA Open House 2018