I wanted to tackle an attendee question submitted during the One-Stop Shopping for Clinical Trial Management: The Value Proposition of a dCRO Paradigm webcast.  I collaborated with Daryl Porter (Chief Technology Officer) and Lisa Jamba (Service Line Architecture Specialist) on this post.

What do you mean by data queries in real time? What is the difference with a traditional EDC where queries are issued also online?

One goal in conducting a trial using a dCRO is to produce clean data in an efficient manner that leverages what an EDC can offer.  For studies conducted in TEMPO e Clinical, there are multiple checkpoints (some automated, some requiring human intervention) to review data entered in the system so it is cleaned as early as possible.

A real time checkpoint is a series of edit checks, both hard and soft, that are programmed within TEMPO™.  An edit check will ‘fire’ when a user attempts to save data that does not meet the validation rule for a particular field or collection of fields (e.g. value outside a specified range, related fields not fully completed, mutually exclusive fields all completed).  A hard edit check prevents the user from saving the data until it meets the validation criteria, a soft edit check is a warning that can be dismissed and allows the data to be saved.

Another checkpoint is to use Dynamic Data Checks, which run in the background and produce reports on a regular interval.  These reports provide a detailed listing of how many records do not meet a given validation rule and provide a way to track the status of those records.  For example, after a study monitor reviews the report, it may be determine that some results require a query to the site while others need no further action.

To round out the checkpoints, monitors review data using tools like form and workflow reviewing and locking, query management reports, study change history reports, and workflow status reports.  Such reports provide quick access to real time data that can be searched, sorted, downloaded and filtered to accommodate the monitor’s preferred method of reviewing data.

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