Validating electronic source data in clinical trials

Data validation is a series of documented tests of the data with the goal of ensuring the quality and integrity of the data.

More specifically, validation is usually concerned with checking four of the eight characteristics of good clinical data – these characteristics are from the first guidance and the first other reference listed below.

It serves as basis for analysis, submission, and approval, labeling and marketing of a compound.

Without good clinical data – well organized, easily accessible and properly cleaned - the value of a drug may not be fully realized.

One area of enhanced clinical trial conduct is believed to be available by moving from paper-based source documents to electronic source documents, that is, eliminating paper from clinical data capture, and collecting the information initially in a computer system.


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