Description
Conducting clinical trials requires a vast amount of documentation. Knowing what the required documentation is at each stage of a trial is essential knowledge for anyone working in trials. Many people start their careers in industry by being a Clinical Trial Assistant (CTA). The CTA role requires an extensive knowledge of documentation and this module is ideal as an introduction or equally as a revision method to help progress to the next level which is often a CRA role. This module details the guidelines and regulations governing the documents, explains what they are and why they are needed as well as providing information about where these should be filed.
Who is the Module Designed For?
The module is designed for anyone involved in Clinical Trials at either the sponsor side, a CRO or at a trial site. The module is ideal for those wishing to enter the industry to help them at interview to demonstrate an understanding of the role of a CTA, CRA or SSC.
Course Contents
Introduction
 Why Do We Have To Have Essential Documents?
Where Do I Start?
Before The Trial
Protocol And Approvals
Subject Documents
IMP Documents
Administration
During the Trial
Ongoing essential documents
Filing: TMF and ISF
Correspondence
After the Trial
Finalising the documentation
Archive
Record Retention
What Prior Knowledge is Needed?
This module details the essential documents required in clinical trials. For more in-depth knowledge of the industry (which is not required to be able to complete this module) the Introduction to Clinical Research Module is recommended. |
