Clinical Trial Start-Up: Effective Planning for Sponsors, CROs, and Sponsor-Investigators

Course Description

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.

Learning Objectives

• 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

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Elizabeth Weeks-Rowe, LVN, C.C.R.A

Click here for complete trainer biographies

Course Outline

Day One

• Module 1: Defining Protocol Requirements and Risks
• Module 2: Development of Protocol Specific Tools
• Module 3: Creation of Communication Plans

Day Two

• 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

Interactive Activities

• 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

This course is for individual registrants only and does not allow for group training.

Accreditation Information

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#: 0778-0000-23-037-L99-P. Released: 10/23.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.