Clinical Research Training for Clinical Trial Assistants

 

Clinical Research Training for Clinical Trial Assistants

Clinical Operations Courses

Questo corso viene soltanto dato in inglese, per questo motivo le informazioni in merito sono soltanto disponibili in inglese.

Are you supporting a clinical team, responsible for filing and/or other administrative tasks? This two-day course will guide you through your responsibilities (GCP and others) and shows you how to document, record, file and archive trial material.

dates
luogo
lingua
850,00 €
Tentimonianze dei participanti
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full 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 stringent standards. In addition, Clinical Trial Assistants also assist with periodical reviews of the clinical project records for accuracy and completeness in order 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 in order to perform this function. This two-day
course covers the basics and regulatory principles that underpin clinical research and also provides a practical coverage of the day to day functions. Theory and interactive exercise make this training the ideal foundation for a career as a CTA.

Who should attend?

Clinical Trial Assistants who are relatively new to the job. This course will also be beneficial to people working in other areas.

Docenti

ICH-GCP as the basis of Clinical Research

ICH-GCP essential documents – sponsor and study centre requirements

Trial Master Files and Investigator Files

To introduce the new Clinical Trial Assistants to drug development

To clarify the difference between medical care and clinical trials

To be familiar with the new CTA with ICH-Good Clinical Practice (GCP) rules

To present the processes of a clinical trial from beginning to end

To explain the why, when and how of essential study documents

Workshops
  • Essential study documents: cases
  • Management of files
  • Quiz on ICH-GCP and essential study documents