Managing protocol amendments in electronically recorded clinical trials

A clinical trial management system and associated methods are provided to manage individual clinical trials running under multiple protocols at once. The disclosure allows clinical trials to be amended during the course of the study with reduced risk of loss of time or data. Patients may be started...

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Bibliographic Details
Main Authors WIJNKER DENNIS, KOCHANSKI DENNIS, LOWE NATHAN, IRIUMI HAYATO, DIXON RON, DEMEYER CHRIS
Format Patent
LanguageEnglish
Published 22.11.2011
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Summary:A clinical trial management system and associated methods are provided to manage individual clinical trials running under multiple protocols at once. The disclosure allows clinical trials to be amended during the course of the study with reduced risk of loss of time or data. Patients may be started under one clinical trial protocol and be moved to another upon approval from the doctor or hospital managing their involvement in the study. In an embodiment, patient data is not moved or altered during a change in protocol to provide a more secure clinical trial system.
Bibliography:Application Number: US20070963767