Regulatory inspections from the competent authority are inevitable when running a clinical trial so it is vitally important to have strategies in place to ensure they occur as smoothly as possible.
This 5 module e-learning course will provide guidance and practical advice to reduce the risk of major findings being discovered. The course will show delegates how to design and implement a compliant trial in accordance with GCP regulations as well as providing guidance for the day of the inspection.
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• Understand the role and remit of a competent authority with regards to clinical trials
• Gain a comprehensive overview of the legislation regarding competent authority inspections and Good Clinical Practice (GCP)
• Learn how to design a clinical trial that is GCP compliant so minimal findings will be discovered when inspectors visit
• Examine the importance of ethics and the competent authority when gaining clinical trial approval
• Develop effective strategies for documentation while the trial is in progress
• Follow essential checklists throughout the module
• Learn to put in place preparation procedures leading up to and including the day of the visit to ensure the correct documentation is ready for the inspector
Duncan Fatz is an independent healthcare consultant who has specialised in medical devices for over a decade. As a Clinical Trials Co-ordinator for the UK’s North West Thames Health Authority and as a researcher for Medical Research Council he has been organising clinical trials and advising on market entry strategies for companies and government organisations for almost 20 years.