{"product_id":"trial-master-file-tmf-for-sponsors-set-up-and-maintenance-2026-10-14","title":"Trial Master File (TMF) for Sponsors: Set-Up and Maintenance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe Trial Master File (TMF) is a collection of the essential documents for a sponsor to demonstrate that they have fulfilled their obligations as sponsor for a clinical trial project as defined by the health authorities. This web seminar reviews the activities that a sponsor uses to set-up, maintain, and perform oversight of the TMF. It examines the changing regulatory landscape that defines sponsors responsibility in managing the TMF. This web seminar will also include handouts and discussion of the TMF Reference Model.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the changing regulatory climate and apply this to the TMF management practices of a sponsor of clinical trials\u003c\/li\u003e \u003cli\u003eExamine the required components of a TMF\u003c\/li\u003e \u003cli\u003eRecommend policy for managing and providing oversight to the TMF\u003c\/li\u003e \u003cli\u003eDiscuss maintenance and quality control of the TMF\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003cli\u003ePolicy Development and Maintenance Personnel \u003c\/li\u003e \u003cli\u003eSponsor\/CRO Personnel involved in the policy, set-up, maintenance, auditing of the TMF\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\u003eDonna W. Dorozinsky, R.N., M.S.N.\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\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$835*\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#: 0778-0000-23-073-L99-P. Released: 10\/23. \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\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375370690925,"sku":"BI17482","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/trial-master-file-tmf-for-sponsors-set-up-and-maintenance-2026-10-14","provider":"Barnett International ","version":"1.0","type":"link"}