With the stern movement towards faster (more efficient), quality driven data for clinical trials, the industry is looking for unique ways to reduce the time from “patient visit” to “data in the clinical study database”.
Although we have moved at a rapid pace within the management of the data (moving from paper CRF data collection to EDC), we find that many sites are still using paper source. Some have indeed moved over to EMR’s (Electronic medical records), however this does not eliminate the gap in getting the data submitted into the clinical study database. This process is largely manual, transcription from the source (either paper or EMR) into the clinical study database.
Recently, as part of the industry drive, the question has been asked; why not enter the data directly into the study database removing/reducing the need for transcription from traditional source documents? Eliminate transcription by making the clinical study database a source designed database (eSource database) where data is entered during the patient visit (directly into the clinical study database). This effectively takes away the need to transcribe the data, having a significant impact on data collection.
The aim of this course is to discuss the notion of collecting/managing eSource data, what are the challenges the industry faces in making such a significant change, as well as how some of these are being overcome and how others are holding the industry back.