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Clinical trial sponsor’s ICH E6(R3) GCP responsibilities for monitoring
Course Summary
Monitoring is one of the principal quality control activities for a clinical trial. The role of monitoring is evolving, from one focused on investigator site visits and source data verification by monitors, to one embracing a variety of approaches including remote and centralised monitoring and/or in-person visits to investigator sites. In this course, we describe the sponsor’s GCP responsibilities for monitoring of the trial.
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) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Summarise the role of monitoring of a clinical trial
• Identify two main approaches to monitoring
• Outline the contents of a monitoring plan
• Specify activities concerning communication with parties conducting the trial
• Specify activities concerning investigator site selection, initiation, management and close-out
• Identify aspects of investigational product management that should be confirmed by monitoring
• Identify monitoring activities concerning clinical trial data
• Summarise expectations for monitoring reports
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 20 minutes
USA, Europe, Other