From Paper to Integrated Data Flow? (PDC->MDC->EDC?)
A short dream about the future of clinical trials Sometimes it feels like clinical trials are very modern and very digital. We have electronic systems, dashboards, remote monitoring, and cloud platforms. But if we look closely at how clinical data actually moves, the story is more interesting. It is not really a story about paper becoming electronic. It is a story about manual transcription slowly disappearing . You could describe the evolution of clinical trials data capture in four stages: PDC → MDC → EDC → IDF And we are probably somewhere between stage 2 and stage 3. Stage 1. PDC (Paper Data Capture) In the beginning, everything was paper. The investigator wrote data in the medical record. Then the site copied the data into a paper CRF. Then someone at the sponsor or CRO entered the paper CRF into a database. So the data was written three times : Source document Paper CRF Database Paper was not the problem. Transcription was the problem. Stage 2....