{"title":"Centralized TMF Management: The CRO Sponsor Partnership","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eMany sponsor organizations transfer responsibility for Trial Master File (TMF) management to their Contract Research Organization (CRO) partners. However, the CRO maintains TMF content for those activities for which they have been delegated. Generally, a TMF is comprised of sponsor, CRO, and vendor content. The relationship between the CRO and the sponsor is critical in ensuring a quality inspection-ready TMF. This web seminar will explore critical activities and responsibilities on the part of the CRO and the sponsor. A successful partnership between these two groups is critical to ensuring an inspection ready file during and at the conclusion of the study. Both partners must understand the activities of each other to ensure that all artifacts within the TMF have been collected and are available within the TMF. A key tool in centralized TMF Management is the TMF Study Map. We will explore the process of developing and managing the TMF Study Map in tracking the content of the TMF during the active phase of the study and at completion. Use of a TMF Plan by the sponsor and the CRO will also be discussed.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eIdentify the responsibilities of the sponsor and CRO for TMF Management\u003c\/li\u003e\n\u003cli\u003eDiscuss the key components of the TMF Plan\u003c\/li\u003e\n\u003cli\u003eDemonstrate understanding of the key components of a TMF Study Map\u003c\/li\u003e\n\u003cli\u003eIdentify strategies for managing the CRO and Sponsor relationship as it relates to the TMF\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eTrial Master File Directors\u003c\/li\u003e\n\u003cli\u003eTrial Master File Managers\u003c\/li\u003e\n\u003cli\u003eTrial Master File Coordinators\u003c\/li\u003e\n\u003cli\u003eClinical Operations Directors\u003c\/li\u003e\n\u003cli\u003eTrial Managers\u003c\/li\u003e\n\u003cli\u003eRecords Management Team Members\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eDonna\nW. Dorozinsky, R.N., M.S.N., 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\nbiographies\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\u003eIncludes up to 20\nparticipants at one site. All participants (up to 20) are eligible for\n“Certificates of Attendance,” and accreditation, provided that accreditation\nrequirements are met. For groups larger than 20 or for additional sites, please\ncall +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eNote: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com\u003c\/b\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the\nAccreditation Council for Pharmacy Education as a provider of continuing\npharmacy education.  Participants will\nreceive 1.5 hours (0.15 CEUs) of continuing education credit for full\nparticipation, including the completion of a pre-test, post-test, and program\nevaluation.  Barnett International will\nissue a receipt of completion for earned CEUs within three weeks of program\ncompletion.  ACPE#: 0778-0000-22-006-L04-P.\nReleased: 5\/22. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/centralized-tmf-management-the-cro-sponsor-partnership.oembed","provider":"Barnett International ","version":"1.0","type":"link"}