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Clinical investigator’s ICH E6(R3) GCP responsibilities
Course Summary
The investigator is the person responsible for the conduct of the clinical trial, including care of the participants for whom they have responsibility. In this course, we describe the investigator’s GCP responsibilities for a range of trial aspects, including delegation of responsibilities, communication with IRB/IEC, safety reporting, investigational product management, and records and data.
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 GCP expectations for the investigator’s qualifications, resources, and provision of access
• Outline GCP provisions concerning delegation of responsibilities to other persons or service providers
• Specify interactions with the IRB/IEC
• Identify requirements for safety reporting
• Discuss considerations concerning a participant’s cessation of treatment or withdrawal from the trial
• Describe responsibilities for investigational product management
• Specify GCP expectations for records, data integrity, and computerised systems
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 30 minutes
USA, Europe, Other