Course Description

The 15-hour Clinical Trial Assistant Fundamentals Program 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. This course provides CTAs information regarding the drug and medical device development and approval process. Best practice techniques for collecting and managing essential documentation stored in the sponsor’s Trial Master File are covered in detail. Activities such as knowledge checks, case scenarios, and simulation exercises reviewing essential documentation for correctness and completeness provide the learner with a hands-on opportunity to apply knowledge gained from the course in their daily roles.

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

• Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practice (GCP)
• Describe the role of 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
• Explain how FDA inspections are conducted at the sponsor and investigative sites 

Course Outline

• Module 1: FDA Regulations and ICH GCP
• Module 2: Roles and Responsibilities of the Clinical Research Team
• Module 3: Investigational Product Development: Drug and Medical Device Approval Process, Importance of Investigational Accountability and Issue Management
• Module 4: Essential Documentation and the Trial Master File: Set Up, Maintenance, and Management
• Module 5: Simulation Exercise Case Study: Review of Essential Documentation Forms for Completeness and Acceptance
• Module 6: Review of Simulation Exercise Study and FDA Inspections and Preparedness

Who Should Attend

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

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.”

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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.

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

Click here for complete trainer biographies

Course Length and Time

Two 2.5 hours classes/week for 3 weeks.

Registration Fees

$1,695 by Early Bird Deadline 

$1,895 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 15 hours (1.5 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#: 0778-0000-24-008-L99-P. Released: 4/24.

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