In a recent post (see hot topic “Getting Data Sooner”) we talked about how using a ‘give some, get some’ strategy in an IRT system contributes to getting your clinical trial data faster. Users are motivated to enter data in a timely fashion because use of the IRT is required for the site to get critical information required for study conduct and subject treatment — for example, their next kit number, or a dosing calculation. Visit data must be entered before the visit can be accomplished…as distinguished from an EDC system where data entry by the site can lag considerably behind.
But what about data that you want to capture in the IRT which doesn’t fit the ‘give some, get some’ strategy? For example, screen failure, early withdrawals, or receipt of drug shipments. For these kinds of data there is nothing the user requires from the system that would force them to do timely entry.
For instances like these, Veracity Logic’s VLIRT® system provides motivation by appealing to basic principles of human psychology… and by manipulating visit/response windows.
For example: When a subject fails screening, the subject obviously does not show up for their next visit. VLIRT® tracks visit status on the main Subjects page (the landing page for most studies) and turns the name and date of the next scheduled activity bright red once the timeframe for that activity has lapsed. Site personnel, our years of experience attest, don’t like to see red — they know their CRA will also “see red” and will be soon demanding to know what’s happening with the subject in question! Users are thus motivated to eliminate this warning color from their table views by entering the necessary screen fail activity.
The same applies to receiving shipments. Acknowledging receipt is a key factor in keeping site drug inventories accurate and up to date within the IRT. The system can assist by turning red the Sent Date of any shipment that was sent more than X days previously and has not yet been modified to a status of Received.
When selecting an IRT, Program Managers should give careful thought to the application of creative designs that can help solve some of these common problems of clinical trials.