{"title":"Managing Clinical Trials During the COVID-19 Pandemic","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eThe\nFDA recognizes that the COVID-19 pandemic may impact the conduct of clinical\ntrials of medical products.  Challenges\nmay arise, for example, from quarantines, site closures, travel limitations,\ninterruptions to the supply chain for the investigational product, or other\nconsiderations if site personnel or trial subjects become infected with\nCOVID-19. These challenges may lead to difficulties in meeting\nprotocol-specified procedures, including administering or using the investigational\nproduct or adhering to protocol-mandated visits and laboratory\/diagnostic\ntesting. The FDA is aware that protocol modifications may be required, and that\nthere may be unavoidable protocol deviations due to COVID-19. This web seminar\nwill discuss the recent FDA guidance for Industry, Investigators and\nInstitutional  Review Boards, Conduct of\nClinical Trials of Medicinal Products during the COVID-19 Pandemic issued March\n2020, which outlines considerations to assist sponsors in assuring the safety\nof trial participants, maintaining compliance with good clinical practice and\nminimizing risks to trial integrity. \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eReview the latest FDA Guidance on COVID-19 and Clinical Trials     \u003c\/li\u003e\n\u003cli\u003eDiscuss FDA and IRB recommendations for handling study variances and safety management due to necessary deviations from approved protocols\u003c\/li\u003e\n\u003cli\u003eEvaluate elements of risk management applications in clinical trials as applied to emerging changes in our society\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eClinical\n     Operations Personnel at Sponsors, CROs and Sites\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eMedical Affairs Specialists and\n     Leaders\u003c\/li\u003e\n\u003cli\u003eProject Managers\/Team Leaders\u003c\/li\u003e\n\u003cli\u003eData Managers\u003c\/li\u003e\n\u003cli\u003eNew Clinical Staff or other Project\n     Team Leaders who will be managing clinical trial projects\u003c\/li\u003e\n\u003cli\u003ePhysician Investigators and Clinical\n     Research Coordinators\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eQuality Assurance\/Control (QA\/QC)\n     Professionals\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003cspan\u003e\u003c\/span\u003e  \u003c\/p\u003e\n\u003cp\u003eNikki\nChristison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003e\u003cspan\u003eClick here for complete trainer\nbiographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003e$735\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIncludes up to 20 participants at one site. All participants\n(up to 20) are eligible for “Certificates of Attendance,” and accreditation,\nprovided that accreditation requirements are met. For groups larger than 20 or for\nadditional sites, please call +1 781.972.5400 or toll-free in the U.S.\n800.856.2556 for pricing.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eBarnett International is accredited by the Accreditation\nCouncil for Pharmacy Education as a provider of continuing pharmacy education. \nParticipants will receive 1.5 hours (0.15 CEUs) of continuing education\ncredit for full participation, including the completion of a pre-test,\npost-test, and program evaluation.  Barnett International will issue\na receipt of completion for earned CEUs within three weeks of program\ncompletion.  ACPE#: 0778-0000-20-088-L04-P. Released: 4\/20. \u003c\/span\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/span\u003e  \u003c\/p\u003e\n\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","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/managing-clinical-trials-during-the-covid-19-pandemic.oembed","provider":"Barnett International ","version":"1.0","type":"link"}