Course Description

This course focuses on the responsibilities of the Clinical Trial Assistant or Associate (CTA), a key administrative member of a project team at the sponsor or CRO. It will start by providing the foundational knowledge of how drugs and medical devices are developed and approved, and the importance of ICH GCP and FDA regulations in the conduct of clinical trials. From there, the various roles and responsibilities of the clinical research team will be introduced, followed by a discussion of the importance of the CTA role in daily administrative operations of clinical trials. Responsibilities the CTA provides to the clinical trial team will be reviewed in depth, which include the following: Study start-up, maintenance, and closure, essential documentation tracking and management using the Trial Master File, distribution and management of adequate studies supplies (e.g., investigational product, laboratory kits, and other items used by the investigative site), reconciliation of documentation, coordination of team meetings, management and updating of study trackers, and the creation of documentation used in clinical trials (e.g., regulatory binder, newsletters).

Learning Objectives

• Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practice (GCP)
• Describe the role the Clinical Trial Assistant and other team members in clinical research
• Describe the investigational product development process: Drug and device
• List essential documentation required in the conduct of clinical research
• Describe the Trial Master File
• Develop tracking tools used in clinical research
• Define investigational product management and accountability in clinical research

Who Should Attend

• Clinical Trial Associates
• Clinical Trial Assistants
• Clinical Coordinators at the sponsor or CRO

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.

Sonja Cooper, Ph.D., M.B.A.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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

Click here for complete trainer biographies

Course Outline

Day One

• Module 1: ICH GCP and FDA Regulations
• Module 2: Roles and Responsibilities of the Clinical Research Team
• Module 3: Investigational Product Development: Drug and Device Approval Process
• Module 4: Investigational Product: Accountability, Management, and Issues Management

Day Two

• Module 5: Trial Master File: Set up, Maintain, and Manage
• Module 6: Clinical Trial Start Up Process and Essential Documentation
• Module 7: Clinical Trial Maintenance and Essential Documentation
• Module 8: Clinical Trial Close Out and Essential Documentation

Interactive Activities

• Define Clinical Research Team Responsibilities
• Trial Master File Set Up Requirements
• Review of Essential Documentation for Completion  and Acceptance: Form FDA 1572, Financial Disclosure Form, Curriculum Vitae, Medical Licensure, IRB Correspondence
• Simulation Exercise: Clinical Trial Start-Up, Maintenance, and Closure

Registration Fees

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#: 0778-0000-22-002-L04-P. Released: 3/22.

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