Mastering Clinical Trial Documents 16th March 2016, London, United Kingdom

SMi is proud to announce the return of the 2nd annual Clinical Trial Documentation Management masterclass in 2016!

Good records management not only has an impact on how effectively an organisation manages its records during the conduct of a clinical study; well-managed clinical study records are critical to demonstrating compliance with GCP and other applicable regulations, as well as supporting regulatory inspections.

Once a clinical study is completed, the clinical study records are the primary - and often the only - evidence of clinical study activities, which are critical to permitting evaluation of the conduct of the study and the quality of the data produced.

Through interactive discussions and group activities, this full-day master-class will outline

• Regulations relating to Trial Master File, including best practice guidance and the latest thinking from legislators and regulators
• How clinical study records can be created and managed in both the immediate- and long-term to ensure the timely availability of an inspection-ready TMF