Clinical Research Training for Clinical Trial Assistants (CTAs)
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 23/11/2023 | Clinical Research Training for Clinical Trial Assistants (CTAs) | Brussels | EUR 900.00 | Book |
| 24/09/2024 | Clinical Research Training for Clinical Trial Assistants (CTAs) | Brussels | EUR 900.00 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Are you supporting a clinical team, responsible for filing and/or other administrative tasks concerning clinical trials? This CTA Training will guide you through responsibilities to achieve compliance with good clinical practice (GCP) and will show you how to properly manage digital and paper trial documents.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Day Face-to-face: 09h00-17h00 | Online: Webinars: 2 sessions of 3 hours |
Course Description
Clinical Trial Assistants (CTAs) have a crucial role to play in the clinical research process. They must adequately maintain all the project’s documentation, records and files and archive them according to the rules. In addition, Clinical Trial Assistants assist with periodical reviews of the clinical project records for accuracy and completeness to remain audit ready.Personnel entering clinical research for the first time and having less than one year’s experience have a great need for information and assistance to perform this function accurately.This course covers regulatory principles that underpin clinical research requirements and provides a practical coverage of the day-to-day functions. Theory and interactive exercises make this training the ideal foundation for a career as a CTA.Programme highlight
- Life Cycle of Clinical Trials
- ICH Good Clinical Practice:
- Why GCP at the basis of Clinical Research?
- Why GCP? Why documents?
- Which documents?
- When & Where documents?
- Paper & Electronic documents guideline by the European Medicines Agency (EMA)
- Good Documentation Practice (GDC)
- How to enhance oversight of trial files & Tips for the CTA
- Preparing for an Audit/Inspection
Learning objectives
- Understand fundamental concepts of clinical trials and processes from start to finish
- Recognise regulatory requirements of the paper and digital trial documentation
- Be familiar with ICH-Good Clinical Practice (GCP) requirements
- Know the why, when, and how of essential study documents
- Grasp the difference between investigators’ and sponsor’s documents
- Connect requirements with daily tasks
- Provide insight in how to enhance management and oversight of trial files
- Develop a sense of how to avoid audit findings
Who should attend
Clinical Trial Assistants who are relatively new to the job, or persons responsible for trial documents who never attended a course focused on trial documentation before. This course will be beneficial as well to people working in other areas in need to understand GCP requirements and how to manage paper and digital formats of trial documentation.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (5)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (0)
- Data Management and Informatics (3)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Anonymous
Amélie KEMPENEERS
BVI Medical