Too busy for EDC?

8th May 2009 No Comments


When things are busy, people tend to become more re-active than pro-active.  Instead of working on a list of tasks that are set out according to a pre-prepared plan, tasks are tackled as they come through the door.   Email for example is often a curse in this regard.   The priority of work tackled is often related to the order that an email appears in your inbox, rather than any real priority for the underlying work.

With a blog, it is necessary to proactively go and monitor feedback.  If you don’t go to the blog site, you don’t recognize the feedback.

EDC can be impacted negatively by this.   Imagine you have very busy site personnel – not hard… Typical online EDC systems contain workflow that often demand pro-active interaction.   A Monitor might for example create a query on data that requires a response from site personnel.   The turnaround time for the query is dependent on the frequency that the site personnel access the EDC system.   For smaller sites without dedicated study personnel the likelihood of an investigator simply not finding the time to login to an online system to look for pending actions.

ECO made a suggestion a few months back regarding the potential use of RSS Feeds – a simple concept with a technical name – whereby such feeds could be used to notify a participant of a particular action.  For example, if a Monitor raised a Query, then this would trigger – at the discretion of the recipient, an RSS / email notification that the action is exists.  The recipient would then click on the link, login, and carry out the action.

So, questions –

Would this cause security concerns?  If the feed included information that might be considered patient confidential – then yes. However, the actual requirement to include any real details in the communication is limited.   The message could simply say ‘You have a new Query on Subject xyz’.

How would this be implemented?   Certainly a system or study switch from the sponsor to make it available.  Next, it should be optional at the user level – when a user signs up, they could opt in for correspondence when things required action, by type.  After that – it would be relatively automatic to the users.   As far as the technology – relatively easy for web based systems provided outbound communications don’t cause security issues.

Would this be called an ‘RSS Feed’ – Why should it?  It tends to be teenagers that recognize the term.  On the other hand, ask an investigator if they would like to be notified of actions they need to be performing – that is understandable.

So, a question for blog readers.   Anyone aware of an EDC system that is already doing this?   Maybe this is already an existing feature in Medidata Rave or PhaseForward Inform products?    Like to share some experiences?

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