The clinical trial investigator carries responsibility for the conduct of the clinical trial at their site, and also has primary responsibility for participant welfare. This training explains why this is so important and where the specific responsibilities come from. We also look at how these responsibilities can be met and also how you can demonstrate compliance and oversight in the event of an inspection.
We can also cover responsibilities when delegating work to site staff or a third party department or vendor: how to train site staff and how to demonstrate oversight of delegated tasks, duties and functions.
The course can be tailored to cover UK, EU and/or US information.
Who is it suitable for?
The course is essential for investigators and investigational site staff working in clinical research and clinical trials, particularly those who are not familiar with the guidelines and regulations they should be following, for example Investigators, Research Nurses, Study Site Coordinators..
Introduction to Clinical Development/Clinical Research
- Objectives of Clinical Research
- What is a clinical trial?
- Phases of Clinical Research
Background to Clinical Trials Regulation
Overview and principles of ICH E6(R2)
- Roles and Responsibilities, with emphasis on investigator responsibilities
- Protocol and amendments
- Investigators Brochure
- Essential Documents
- Investigator’s Qualifications and Agreements
- Adequate Resources
- Medical Care of Trial Subjects
- Communication with IRB/IEC
- Compliance with Protocol
- Investigational Product(s)
- Randomization Procedures and Unblinding
- Informed Consent of Trial Subjects
- Records and Reports
- Progress Reports
- Safety Reporting
- Premature Termination or Suspension of a Trial
- Final Report(s) by Investigator.
Audit and Inspection
Fraud and Misconduct
Please contact me for more information and to organise your course.
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