{"product_id":"sponsor-management-of-investigator-non-compliance-2026-08-10","title":"Sponsor Management of Investigator Non-Compliance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eInvestigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites. \u003c\/p\u003e\u003cp\u003eWith the promise of more sponsor inspections, the sponsor management of investigator non-compliance is an obligation that requires comprehensive management approaches that lead to control of investigational product, data integrity, and adequate documentation for regulatory inspection of sponsors monitoring programs and\/or investigative sites. Seven steps in compliance management of research sites will be presented for the participants to assess their current practices for gaps and risks for preparing for potential regulatory inspection evaluating compliance management of research sites. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eCategorize investigator non-compliance\u003c\/li\u003e \u003cli\u003eDefine adequate escalation of non-compliance\u003c\/li\u003e \u003cli\u003eSummarize proactive investigator training related to sponsor's response to non-compliance\u003c\/li\u003e \u003cli\u003eEmploy seven comprehensive steps in compliance management\u003c\/li\u003e \u003cli\u003eDetect trending to better anticipate compliance issues\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eSponsor Senior Management\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associate Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eQuality Assurance\/Compliance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\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$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#: 0778-0000-25-014-L99-P. Released: 2\/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 \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":53375390482797,"sku":"BI17359","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/sponsor-management-of-investigator-non-compliance-2026-08-10","provider":"Barnett International ","version":"1.0","type":"link"}