The following presentation was recently given to the Triangle Chapter of the Association for Clinical Research Professional (ACRP). Enjoy!
One of the questions most frequently asked by clients during demos of the Veracity Logic IRT (IVR/IWR) system is how best to handle the problem of having to reconcile data between a study’s IRT and EDC platforms.
The answer is twofold, but simple: First, move data between the two systems in only one direction. Second, set up your study so you don’t duplicate data in the two systems.
Electronic integration between the IRT and the EDC systems should be a one-way arrow – ideally, data should be ‘pushed’ from the IRT to the EDC. Not only is this cheaper than requiring a two-way transfer of data (i.e., also ‘pulling’ from the EDC into the IRT, which can double costs), but, depending on the EDC platform being used, it may also be technologically simpler, since EDC APIs to receive data may be more available than APIs to push data.
It’s essential to have a strong 24/7 Help Desk backing up your IRT vendor. But be sure the IRT system you’re choosing also has a sufficient array of ‘do it yourself’ options that will empower your study team to safely do system updates and save time and money by acting independently of the Help Desk.
Here are just four ways to reduce the need for vendor intervention:
1. Look for a system with a login screen that enables users who’ve forgotten (lost) their passwords to simply request a temporary credential to be sent to their email, without having to contact the Help Desk. This is the one item that most directly reduces the amount of Help Desk involvement!
We’ve seen confusion in recent IRT (IVR/IWR) RFPs and study protocols in the use of ‘strata’ and ‘cohort’ when describing desired approaches to randomization. The words are often used in opposition – that is, one is often specified when it’s really the other that’s required.
This confusion in terminology can negatively impact the bidding timeframe, requiring back and forth clarification between vendor and sponsor, or worse yet, can wrongly inflate or deflate the final bid tally. Correcting after the fact also takes additional time. Better by far to specify the strata or cohort requirements correctly from the outset