Inaccurate data entry can be costly. Without accurate data, orders can't be filled correctly and market forecasting can run amok. At Isis Pharmaceuticals, a $26 million drug development company in Carlsbad, Calif., database records are routinely reviewed by the Food and Drug Administration, which could bring operations to a halt if a few figures are entered incorrectly. So Isis adheres religiously to a total quality system for data entry that keeps the database as accurate as possible. Here are the five steps in the process.
- Manual review. Clinical-data coordinator checks entry manually for obvious mistakes.
- Double entry. Once an individual's information has been punched into the database, a second data entry operator reenters the same information in a new file. The computer then automatically compares the two files and prints out a list of inconsistencies, which must be reconciled by the clinical-data coordinator.
- Visual verification. A data manager compares the data that were entered against the original handwritten forms.
- Electronic verification. A data manager runs a series of relational edit-check programs that examine data in selected fields within the database to make sure they are logical and consistent.
- Final audit. Once an entire clinical trial is completed, Stuart Nixon, director of clinical-data management and biostatistics, and his team conduct one final audit by checking a representative cross-section of data against the original handwritten forms.