Mastering Clinical Trial Documents

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+44 (0) 20 7827 6078

This full-day Masterclass will outline the regulations that relate to Trial Master Files and explain how clinical study records can be created and managed to ensure the timely availability of an inspection-ready TMF. Once a clinical trial ends, the trial documents are the only remaining artefact that permits evaluation of the conduct of the trial and the quality of the data produced. They are critical to demonstrating compliance with GCP and other applicable regulations. Attendance at this workshop will help you understand the requirements for document creation; how documents can be managed efficiently and effectively so that they can be easily found; help you to avoid unnecessary record keeping; help you to get the most out of your trial records; and avoid resource-intensive file clean-ups when you get notified of audits and inspections. Good records management practice impacts not just your ability to support a regulatory inspection. It has a major impact on how effectively you can manage your documents while a trial is running. Why you should attend this masterclass: Attendance at this workshop will enable participants to: • understand the requirements for clinical study documents; • comprehend how documents can be managed more effectively; • learn how to make best use of clinical trial records to enhance information sharing and facilitate more efficient operations; and • improve inspection–readiness to avoid resource-intensive preparations when notified of impending audits and inspections This masterclass will be hosted by: Russel Joyce, Director, Heath Barrowcliff Consulting Ltd 

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