{"product_id":"protocol-deviations-documenting-managing-and-reporting-2026-09-03","title":"Protocol Deviations: Documenting, Managing, and Reporting","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eAccording to both U.S. regulations and the ICH GCP E6 Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan\/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval\/favorable opinion from the IRB\/IEC, except when necessary to eliminate an immediate safety issue for research subjects. However, unapproved protocol deviations occur in every study and at every site. There is a growing recognition within the industry as to the importance of appropriately managing protocol deviations. This web seminar provides tips and strategies to help participants anticipate, manage, and minimize the impact of protocol deviations. Investigators and Clinical Research Associates (CRAs) will learn how to appropriately document and report protocol deviations, with a focus on preventing recurrence. Internal study team members will learn how to implement a structured approach to managing significant deviations that impact subject safety and\/or data integrity. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the components of protocol deviation documentation and reporting\u003c\/li\u003e \u003cli\u003eIdentify stakeholder roles in the management of protocol deviations\u003c\/li\u003e \u003cli\u003eDescribe a process to proactively identify, track, and evaluate deviations for greater effectiveness in study management\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eSponsor\/CRO Project Managers\u003c\/li\u003e \u003cli\u003eSponsor\/CRO Study Managers\u003c\/li\u003e \u003cli\u003eSponsor\/CRO Clinical Research Associates\u003c\/li\u003e \u003cli\u003eSponsor\/CRO Clinical Research Associate Managers\u003c\/li\u003e \u003cli\u003eClinical Investigators\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eQuality Assurance Professionals\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A.,T.I.A.C.R.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-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#: 0778-0000-24-025-L99-P. Released: 1\/24. \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 \u003cfont color=\"black\" face=\"Verdana, Arial, Helvetica, sans-serif\" size=\"-1\"\u003e \u003c\/font\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375388287341,"sku":"BI17397","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/protocol-deviations-documenting-managing-and-reporting-2026-09-03","provider":"Barnett International ","version":"1.0","type":"link"}