Barnett International's Core Curriculum courses are comprehensive role-based training programs designed to provide participants with hands-on, in-person training. Held four times a year during Barnett’s “Clinical Research Training Weeks,” courses take place at state-of-the-art corporate meeting centers or in centrally located hotels on the East and West Coasts of the U.S., and offer focused, performance-based training and employee development.
Clinical Trial Start-Up: Effective Planning for Sponsors, CROs, and Sponsor-Investigators
This course offering will take place live via WebEx from 12:00 PM – 7:00 PM Eastern each day. Participants will receive an email confirmation that includes the seminar link to enter the meeting room as well as the audio connection information.
Successful 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.
- Identify project requirements and risks
- Create tools and templates for clinical trial startup planning
- Identify three benefits of a communication plan
- Examine a WBS in clinical trial start-up
- Identify situations where a WBS have positive impact on clinical trial start-up planning
Who Should Attend
- Clinical Project Managers
- Clinical Trial Managers
- Clinical Research Associates
- Clinical Trial Assistants
- Other team members from the sponsor/ CRO working in start-up of clinical trials with investigative sites
- Clinical Research Coordinators
- Clinical Research Team Leaders/Managers
- Other team members at the investigative site responsible for investigative site start-up activities
The course will be led by one of the following instructors:
Marla Hoelle, R.N., B.S.N, C.C.R.A., ACRP-PM., P.M.P.
Day One: 8:30 a.m. – 5:00 p.m.
- Module 1: Defining Protocol Requirements and Risks
- Module 2: Development of Protocol Specific Tools
- Module 3: Creation of Communication Plans
Day Two: 8:30 a.m. – 5:00 p.m.
- Module 4: Work Breakdown Structure: Effective planning tool for your team and investigative site
- Module 5: Application 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
- Module 6: Lessons Learned: Discussion and review of application
- Case Study: Mapping Out Protocol Start-Up Plan: Assessment, Needs, and Risk — Identification, Planning, Mitigation
- Case Study: Create a Communication Plan for Successful Site Start-Up
- Create Tools: FIQ, SQV Questions, and Site Submission of IRB/IEC and CTA Questionnaire
- Case Study: Develop a WBS
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
Barnett 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#: 0778-0000-18-022-L01-P. Released: 3/18.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.