Change

Change Management

When selecting an IRT provider, be sure to ask how quickly data changes and system modifications can be accomplished, both at study start and as the trial proceeds. Veracity Logic’s approach reduces costs, empowers users, maintains quality standards, and shortens both the time and the paperwork involved with managing change. Our robust Issue Tracking System captures all user concerns and requests for change throughout the study…and provides an easy way to ensure all requirements are addressed in a timely manner.

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User Power: Managing Cohorts

 The Problem: The management of multiple cohorts is a standard offering of most IRTs. In the common sequential model, when Cohort 1 reaches  a pre-designated limit the cohort is closed by the system and subjects can no longer be enrolled into that cohort. Problem: The design of your study is such that the maximum number of subjects in each of your […]

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Handling Data Corrections…

Problem: There are many options for processing manual data changes in an IRT system. Some vendors make all data changes for the clinical site users. Others have electronic systems where users can request and approve changes, while still others require ‘wet’ signatures. What’s the best option for achieving the two key goals of change control, i.e., documenting […]

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 […]