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Interim analysis

 

It is common practice for clinical trials to include a plan for interim analyses of the data and to monitor safety. An interim analysis is any assessment of data during the patient enrolment or follow-up stages of a trial.  It’s purpose can be assessing site performance, the quality of the data collected or treatment effects.  You can detect trends that might warrant modification of the protocol, change in type or format of data being collected or even trial termination.

If you want to perform an interim analysis you need to export data from OpenClinica. Data can be exported by someone who has the role of Study Director, Data Manager, Data Specialist, Investigator or Monitor. The OpenClinica Reference guide on https://docs.openclinica.com/3.1/openclinica-user-guide contains a wide variety of reference information, including a glossary for quick access to definitions of terms used in OpenClinica and throughout the guide.

There is also a quick reference guide available which describes in detail how to export data from OpenClinica. A separate manual is available for exporting OpenClinica data to SPSS and is based on version 3.1.4.1 of OpenClinica.

 

Important remark: please be aware that the exported dataset may contain personal and identifiable information; handle the dataset with care and use secure transport methods. Do not send the file via unprotected Email.


 

 

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