Course Description

Successful and timely clinical trial start-up is key for sponsors, CROs and investigative sites. Too often, clinical trial start-up is challenged by delays in investigator selection, Institutional Review Board (IRB)/Ethics Committee (EC) budget approvals, or the discovery that once a site is initiated, the investigator/site indicates the protocol is not feasible due to lack of subjects. This online 10-Hour Clinical Trial Start-Up Series will address how to overcome challenges encountered in clinical trial start-up from understanding protocol requirements and risks, exploring methods to improve the investigator/site understanding of eligibility criteria, use of a Work Breakdown Structure (WBS) to help drive timely IRB/EC and Clinical Trial Agreement (CTA)/budget approvals, and tools and techniques for more engaging/ interactive site qualification and initiation visits. Case studies, handouts, and tools will be provided for immediate implementation to address your start-up needs.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Identify protocol requirements and risks
• Create tools and templates for clinical trial start-up planning
• Examine best practices to improve Investigator/site selection
• Create engaging interactions with Investigator/site personnel during site interactions
• Identify situations where a Work Breakdown Structure (WBS) would have a positive impact on clinical trial start-up

Course Outline

• Module 1: The Clinical Protocol: Evaluation of Requirements and Risks
• Module 2: Development of the Investigator/Site Feasibility Questionnaire: Asking the Right Questions for Your Protocol
• Module 3: Investigator/Site Selection Visit: Matching Protocol Needs to Your Investigator/Site
• Module 4: Tools to Support Clinical Teams for Timely Start-Up: Trackers, Questionnaires, and Communication Practices that Yield Results
• Module 5: The Site Initiation Visit: Engaging and Interactive Gets Results

Who Should Attend

• Clinical Project Managers/Leaders
• Clinical Trial Managers
• Clinical Research Associates
• Clinical Trial Assistants
• Other Team Members from sponsors/CROs working in clinical trial start-up
• Clinical research Team Members from Investigative Sites seeking to improve their start-up practices

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

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

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.

Nazma M. Rosado, MAOL, P.M.P., CPLP, 6σ, CMQ/OE

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

Click here for complete trainer biographies

Course Length and Time

2 hours/week for 5 weeks.

Registration Fees

$1,595 by Early Bird Deadline 

$1,795 after Early Bird Deadline

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

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 10 hours (1.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-040-L99-P. Released: 8/23.  

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