Mastering Clinical Trial Documents

Dec 10, 2013, 9:00AM to 4:30PM

Location Coram Street
London, UK
Cost £599
Details Once a clinical trial ends, the trial documents are the only remaining artifact that permits evaluation of the conduct of the trial and the quality of the data produced.


Documents are critical to demonstrating compliance with GCP and other applicable regulations. This masterclass will outline the regulations that relate to the Trial Master File – including the latest thinking from the European Medicines Agency - and will explain how documents can be created and managed in a way that should ensure an inspection-ready TMF is available. The additional coordination required to collect and maintain trial documents can expose both life science companies and the CROs, themselves, to compliance risk.

SMi's masterclass hosted by Rammell Consulting, 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. This full day masterclass will involve interactive seminars, discussions, and group activities.

Contact Jonathan Collins
Tel: +44 (0) 20 7827 6734
Email: jcollins@smi-online.co.uk
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Price: £599
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Keywords: etmf, electronic records, tmf inspection, clinical trial documentation, clinical trial regulation, tmf, trial master file, gcp, good clinical practice, quality assurance, quality control, clinical trials.
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Artists / Speakers: Rammell Consulting Ltd, Eldin Rammell, Managing Director.
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Venue Holiday Inn Bloomsbury
RSVP http://atnd.it/1d8ikMV

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