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 user approval while streamlining the process so it doesn’t take days to make a change?
At Veracity Logic, we put our emphasis on enabling and training authorized end-users to handle most manual data corrections themselves, just as they do in their EDC systems. The range of edit permissions varies based on the needs of each project.
We’ve found that most users not only don’t mind having the power to make many of the data corrections within the IRT, they actually prefer it to having to generate paper requests and factor in vendor response time (not to mention the increased cost of PM and Help Desk involvement).
For changes that technologically require vendor action, we make the change for them using a documented paper/signature trail. We don’t require the document contain a ‘wet’ signature, a faxed or PDF’d copy is sufficient.
Regardless of the method used, a proper audit trail must be kept whenever changes are made to clinical data by authorized users and it needs to include a justification/reason for the change. That said, when such capabilities (proper authorization, a full audit trail and requirement for recording the reason for a data change) are included in an IRT system, tied with the ability to ‘attach’ notes to records within the database, the additional time/effort of a laborious paper-based process is unnecessary.