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
- Examine a WBS in clinical trial
- Identify situations where a WBS have
positive impact on clinical trial start-up planning
- 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
- Other team members at the
investigative site responsible for investigative site start-up activities
The course will be led by one of the following
Hoelle, R.N., B.S.N, C.C.R.A.-PM., P.M.P.
Click here for complete trainer
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
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
- 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
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.
Click here for our seminar
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.
this course at your company! For more information, contact Naila Ganatra at +1