{"product_id":"clinical-trial-start-up-effective-planning-for-sponsors-cros-and-sponsor-investigators-2026-12-10","title":"Clinical Trial Start-Up: Effective Planning for Sponsors, CROs, and Sponsor-Investigators","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eSuccessful projects require planning, and often, start-up processes are not planned or defined, and risks are not considered. This lack of effective planning often leaves sponsors, CROs, and investigative sites behind schedule, which leads to delays in site selection, approval of IRB\/IEC and clinical trial agreements (CTAs), and ultimately enrollment of subjects. Project management principles are introduced in this course to address clinical trial start-up challenges. Whether you are working for a sponsor, CRO, or as a Sponsor-Investigator (SI), this course will identify successful project planning techniques that can be used to effectively address the issues surrounding clinical trial start-up challenges. This course focuses on building a collaborative working relationship at the sponsor (CRO or SI) and the investigative site to help improve turnaround times with upfront planning, communication, and the use of a Work Breakdown Structure (WBS) in your project planning. Case studies, schematics, handouts, and tools will be provided for immediate implementation to address your start-up needs.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify project requirements and risks\u003c\/li\u003e \u003cli\u003eCreate tools and templates for clinical trial startup planning\u003c\/li\u003e \u003cli\u003eIdentify three benefits of a communication plan\u003c\/li\u003e \u003cli\u003eExamine a WBS in clinical trial start-up\u003c\/li\u003e \u003cli\u003eIdentify situations where a WBS have positive impact on clinical trial start-up planning\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Project Managers\u003c\/li\u003e \u003cli\u003eClinical Trial Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Trial Assistants\u003c\/li\u003e \u003cli\u003eOther team members from the sponsor\/ CRO working in start-up of clinical trials with investigative sites\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eClinical Research Team Leaders\/Managers\u003c\/li\u003e \u003cli\u003eOther team members at the investigative site responsible for investigative site start-up activities\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A.,T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eNazma M. Rosado, MAOL, P.M.P., CPLP, 6σ, CMQ\/OE\u003c\/p\u003e\u003cp\u003eElizabeth Weeks-Rowe, LVN, C.C.R.A\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\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\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 1:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefining Protocol Requirements and Risks\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 2:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDevelopment of Protocol Specific Tools\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 3:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eCreation of Communication Plans\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 4:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eWork Breakdown Structure: Effective planning tool for your team and investigative site\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 5:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eApplication of the Start-Up Process: Development of a Work Breakdown Structure from time of site selection through IRB\/IEC, budget\/clinical trial agreement approval, and scheduling of site initiation visit\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 6:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eLessons Learned: Discussion and review of application\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eCase Study: Mapping Out Protocol Start-Up Plan: Assessment, Needs, and Risk - Identification, Planning, Mitigation\u003c\/li\u003e \u003cli\u003eCase Study: Create a Communication Plan for Successful Site Start-Up\u003c\/li\u003e \u003cli\u003eCreate Tools: FIQ, SQV Questions, and Site Submission of IRB\/IEC and CTA Questionnaire\u003c\/li\u003e \u003cli\u003eCase Study: Develop a WBS\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cdiv\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e \u003cbr\u003e \u003c\/div\u003e\u003cdiv\u003e\u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e\u003c\/div\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 15 hours (1.5 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#: 0778-0000-23-037-L99-P. Released: 10\/23. \u003c\/p\u003e\u003cp\u003e \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\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474460074349,"sku":"SWBM1226","price":1895.0,"currency_code":"USD","in_stock":false},{"title":"Academic","offer_id":53474460107117,"sku":"SWBM1226-ACADEMIC","price":1475.0,"currency_code":"USD","in_stock":false}],"url":"https:\/\/www.barnettinternational.com\/products\/clinical-trial-start-up-effective-planning-for-sponsors-cros-and-sponsor-investigators-2026-12-10","provider":"Barnett International ","version":"1.0","type":"link"}