Electronic case report forms (eCRFs) are playing a more extensive role in the collection and management of clinical data, addressing the needs of pharmaceutical, medical device, biotechnology and health care industries to make the management of case histories less time-consuming,more efficient and more accurate.Whether eCRFs are used to capture information directly into an underlying database or to enter and manage data first collected on paper forms, by moving data entry closer to the source of data, not only is the chance for errors greatly reduced, but the time-todatabase "lock" and subsequent submission is generally much faster. As a result, companies are shifting rapidly to the use of eCRFs to manage their electronic study records.
As this shift occurs, it is important that study sponsors develop and follow rigorous and comprehensive testing and validation plans prior to releasing the eCRFs for use.
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