It is not uncommon to make changes to a study after subjects have enrolled. If you use Oracle Clinical /Remote Data Capture (OC/RDC) to manage your clinical data, then you know that making those changes can be quite easy. However, even the simplest change could result in unforeseen consequences with the potential to undermine your study. That’s why it’s critical to perform a thorough risk analysis before making any changes.
Perficient’s Tammy Dutkin, director of clinical data management and EDC, discussed the process of evaluating and executing post-production changes in OC/RDC.