Should eClinical systems be 'EndPoint' aware

 

EDC Wizard made some interest points in response to the earlier posting 'EDC EndPoints'

The original posting was probably incorrectly titled. It should have maybe said - "Should eClinical systems be EndPoint aware?"

I tend to stay away from the term EDC when I can. I think this term does not really apply now to some of the leading 'EDC' vendors. I think they are still labelled as EDC as customers expect to purchase an EDC solution. However, today, they are more 'Clinical Trial Support Suites'.  Vendors are adding more and more upstream and downstream functionality.  In doing so, some are clueing up to the fact that the 'bit in the middle' - the data capture and cleaning part - may benefit from early involvement from other parties traditionally left out of the mix.

SDV'ing is an interesting point. EDC Wizard states that

Many sponsors are implementing reduced SDV plans that take a risk-based approach to comparing source data to EDC entries

The activity list for Monitors will increasingly be led by the eClinical system tools.  They track what has, and what has not been SDV'd. With a % being applied, a model needs to be applied by the eClinical tool that applies this % appropriately.  I am not aware of a tool that has successfully implemented this. Another challenge exists regarding the classification of data that is eSource and that which is not.

What has, and what has not been SDV'd should not be shown to the Investigator by the tool. I believe most tools support differing views based on user roles. This functionality should be applied.

EDC Wizard goes on to say;

I am not sure I would recommend that EDC systems be modified to flag data as primary, secondary, SDV, or non-SDV. It's hard enough to move from protocol to EDC database to study start without adding more complications to database builds.

A very valid point - tools are becoming increasingly complex. 'Keep it Simple' is certainly a solid principle to hold where possible. However - with the current model of blanket significance / locking --> data delivery, I think we are missing an opportunity for early decision making.  If the move towards define once, use many times continues to be applied with eClinical systems, then complexity may reduce rather than increase - define the endpoint criteria up-front in one place, and have this information take downstream into EDC and onto data delivery.

How do Monitors work on site with Online only systems?

 

I have a question that I would like to ask.

When Monitors go out onsite to carry out Monitoring activities, and, the monitoring activity involves working with the data captured into an EDC system - how do they do it if the EDC system is online only?

• They could use the site computer - but, often this is a computer shared for other purposes. With increasing security at site locations, often it is not appropriate for an external person to login to a site system.
• They could use their own laptop with the site network link?  Using the site network infrastructure is often a big no-no. The site will often not provide a wireless network key, again due to security restrictions
• They could use their own laptop, but with a 3G or similar wireless technology?  Well - not in many hospital establishments.  Mobile communication, including 3G is not permitted.

So, without resorting to an offline solution, how do they work?