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Clinical trial investigator’s GCP responsibilities
Course Summary
A clinical investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP. Duties and functions discussed in this short course include: provision of adequate resources; liaison with IRB/IEC; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.
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
• Identify qualifications and resources that an investigator should be able to demonstrate
• Describe the extent to which deviation from the protocol is acceptable
• Discuss the management of investigational products
• Describe how data should be recorded and corrected and how records should be maintained
• Classify adverse events and specify criteria for reporting them
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