change

We’re midway through the study and the protocol has changed…but only for some sites. Arghh…!

Problem:

The IRT was originally configured to accept eligible subjects with a maximum age of 75.  Midway through the trial, the maximum age was increased to 80…but only for sites whose IRBs had approved the increased age!  What to do?

Solution:

Veracity Logic configures a flag on the  IRT Site Information page that allows Clinical Project Managers to designate which protocol amendment each site is authorized to use. The system adjusts accordingly, using either the 75 or the 80 age limit, for new subjects at each site. No need for one-size-fits-all! And Biostatisticians have the protocol information readily at their fingertips when it comes time for analysis.

Flexibility in accommodating changes … one of the most important aspects of vetting your IRT!

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