{"title":"TMF\/eTMF Audit Strategies","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe\nprocess for managing the Trial Master File (TMF) has changed drastically in the\nlast 10 years. Many organizations have moved to an electronic TMF (eTMF), yet\nsome organizations still operate with a paper TMF or a hybrid of the two. A successful audit evaluates the processes that were used to manage the TMF to ensure that they are consistent with procedural documents and study plans. This web seminar\nwill present a strategy for conducting a TMF audit that identifies gaps that\nhave potential impact on the quality of the TMF. We will explore strategies for\nusing the power of an eTMF to identify gaps that could result in inspection\nfindings. The power of the TMF Reference Model in organizing the audit and\nidentifying key artifacts that potentially impact Good Clinical Practice (GCP)\ncompliance will also be discussed. Finally, we will examine strategies for the\naudit of a paper TMF as well as an eTMF, including critical files to review and\nhow to spot trends in non-compliance. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eExplain the value of the TMF Reference Model in\n     organizing an audit to ensure efficient identification of GCP\n     non-compliance\u003c\/li\u003e\n\u003cli\u003eIdentify strategies for conducting\n     an audit of an eTMF that employ the enhanced capabilities of an eTMF\u003c\/li\u003e\n\u003cli\u003eIdentify strategies for auditing a\n     TMF that focuses on artifacts impacting the quality and GCP compliance of\n     the TMF\/eTMF\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eGood Clinical Practice Auditors\u003c\/li\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\u003cspan\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003e\u003cspan\u003eClick here for complete trainer\nbiographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\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\u003cspan\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\/span\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\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\/strong\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003e\u003cspan\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#: \u003c\/span\u003e0778-0000-21-051-L04-P\u003cspan\u003e.\nReleased: 10\/21. \u003c\/span\u003e\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/tmf-etmf-audit-strategies.oembed","provider":"Barnett International ","version":"1.0","type":"link"}