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ICH E6(R3) GCP expectations for records and data governance
Course Summary
Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this course, we describe important examples of records expected to be created and maintained in a clinical trial and which ICH GCP considers to be essential to trial conduct. Regulatory inspectors increasingly focus on issues of data integrity, and ICH E6(R3) includes a new section on data governance measures. We describe the implications of the expectations set out in the guideline for the management of data and computerised systems in clinical research.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s)โfor a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
โข Identify essential records for a clinical trial
โข Outline the contents of an investigatorโs brochure
โข Outline the contents of a trial protocol
โข Give examples of source records and data acquisition tools
โข Identify trial aspects that are subject to data governance expectations
Who will benefit from this course
This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.
Module Outline
Roles
Research, Regulatory, Compliance
CPD Points
No
Region
Level
Foundation
Course Study Time
Approx 50 minutes
USA, Europe, Other