Seamless Mid-Study IRT Implementation: Preserving Data Integrity With Retrospective Manual Entry

Mid-study protocol amendments that add randomization can leave sponsors exposed—especially when a trial launches without an Interactive Response Technology (IRT) system in place. Reconstructing subject and inventory history after the fact carries real risk: misaligned screening and randomization IDs, mismatches between IRT and EDC records, and audit gaps that can jeopardize regulatory confidence. This case study examines how one oncology sponsor navigated exactly that challenge, implementing IRT mid-study across five sites without disrupting ongoing enrollment or compromising data integrity. For sponsors facing a similar mid-study shift, this case study offers a practical framework for balancing speed, accuracy, and regulatory compliance—helping study teams avoid downstream data reconciliation issues and protect study integrity when operational complexity increases unexpectedly.