{"product_id":"investigator-initiated-trials-roles-and-responsibilities-2027-01-07","title":"Investigator Initiated Trials: Roles and Responsibilities","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eInvestigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine an Investigator Initiated Trial (IIT)\u003c\/li\u003e \u003cli\u003eReview the applicable federal regulations for IITs, including sponsor and investigator responsibilities\u003c\/li\u003e \u003cli\u003eReview the steps involved in initiating an IIT with a sponsor and review regulatory reporting requirements \u003c\/li\u003e \u003cli\u003eIdentify essential documentation (Trial Master File) for the Sponsor-Investigator using the DIA TMF Reference Model to remain audit ready\u003c\/li\u003e \u003cli\u003eIdentify approaches to minimize risks associated with IITs by avoiding common pitfalls - learn from existing FDA Warning Letters of deficiencies\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eInvestigators\/Site Study Team Members\u003c\/li\u003e \u003cli\u003eSponsor Study Team Members\u003c\/li\u003e \u003cli\u003eEthics Committee Members\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors: \u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R. \u003c\/p\u003e\u003cp\u003eJanet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.\u003c\/p\u003e\u003cp\u003eLily Romero, P.A., C.C.R.C.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e \u003c\/span\u003e \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-010-L99-P. Released: 1\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375365415277,"sku":"BI17612","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/investigator-initiated-trials-roles-and-responsibilities-2027-01-07","provider":"Barnett International ","version":"1.0","type":"link"}