A general finding in the clinical trials industry is that entering visit data into an EDC system by clinical site personnel lags, on average, 11 days behind a clinic visit. This issue of belated entry persists in the industry despite the hopes, dreams, wishes, urgings, and incentives offered by Sponsors and CROs for quicker data access.
Typically, IRT (IWR/IVR) systems, which provide clinical personnel with critical information like Subject IDs, randomization to treatment groups, and kit numbers for proper drug dispensation at site visits, enjoy timelier entry of visit data than do EDC systems. This ‘first-in/early data’ positioning makes IRT systems highly valuable components of a trial’s data collection efforts.
But the lesson for IRT providers is clear: Timely use of the IRT is a result of the system providing the clinical site with something it needs to proceed with the trial. An assigned Subject ID is the first essential bit of information a site requires. And obtaining the correct kit number for the drug to be dispensed to the subject at a given visit (based on treatment group assignment made by the IRT) requires the site to enter activity information for that visit in real time.
The corollary lesson is also clear: In instances where the IRT asks the site to enter data that does not provide site personnel with something they need IRT providers can expect – and, in fact, do experience – less real-time compliance by sites.
For example: For the IRT to accurately maintain the record of a site’s investigational drug inventory, site personnel are asked to enter confirmation when they have ‘Received’ a drug shipment. The fact that there is no immediate need for the site to access the IRT to obtain any necessary information leads to the EDC-like compliance IRT systems typically experience on this point!
But when a subject visit occurs that requires a certain kit type and site personnel attempting to record the visit get an IRT message that there are ‘insufficient kits’ to complete the activity, that’s when the shipment gets logged as Received.
The take-home message is this: Limit use of the IRT as far as possible to activities that provide the site with something it needs to proceed with the trial. If an occasional data point violates this premise, have the system do something additional to increase the odds of compliance. For example, in the Veracity Logic IRT overdue activities appear on the screen in red. Site users either must do something to eliminate the red ‘warning’– or experience a call from an anxious CRA.
As penny-savers like to say, every little bit helps!
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