{"product_id":"essential-documentation-in-clinical-trials-at-research-sites-2027-01-13","title":"Essential Documentation in Clinical Trials at Research Sites","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eEssential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine clinical research essential documentation\u003c\/li\u003e \u003cli\u003eDetermine essential subject and non-subject specific documentation requirements per trial\u003c\/li\u003e \u003cli\u003eDiscuss essential documentation for drug vs. device vs. combination products\u003c\/li\u003e \u003cli\u003ePrepare for regulatory inspection: Proactive and reactive use of essential documentation\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\u003c\/li\u003e \u003cli\u003eResearch Site Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associate Managers\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eLaura Kelly, B.S.\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#: 778-0000-23-013-L99-P. Released: 1\/23. \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":53375364759917,"sku":"BI17624","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/essential-documentation-in-clinical-trials-at-research-sites-2027-01-13","provider":"Barnett International ","version":"1.0","type":"link"}