This book contains concise, well-researched information covering all aspects of data management--from handling early phase I studies in volunteers to presenting final reports for regulatory purposes.

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Multinational contributors renowned for their extensive industry experience offer concise, well-researched information on all aspects of data management. Coverage ranges from handling early phase I studies in volunteers to the presentation of final reports for regulatory purposes. Uses an international approach to describe such specialized needs as clinical trial monitoring, the audit process and regulatory requirements.

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