Whether they are test-marketing a new fruit drink, beta-testing computer software, or running clinical trials on an antibiotic, companies share a common concern. To accelerate their new product's trip to the marketplace, they need fast and reliable methods for gathering and analyzing data. The foundation is a solid information system.
But for any system to be worth its price, data entry must be perfect. To guard against errors, Isis Pharmaceuticals, a $26-million drug development company in Carlsbad, Calif., devised this five-step program:
1. Manual review. Before a clerk enters a patient's information into the computer, a data-entry operator reads the record, checking for obvious mistakes. For example, a patient's age should never be 150.
2. Double entry. Once the information has been keyed into the database, a second data-entry operator reenters the same record into a new file. The computer then automatically prints a list of inconsistencies, and the two operators reconcile the differences.
3. Visual verification. A data manager compares the entered data against the original handwritten notations.
4. Electronic verification. A data manager runs a series of relational edit-check programs to verify that data in selected fields of the database are logical and consistent.
5. Final audit. When an entire clinical trial is complete, Isis managers run a final audit, checking a representative cross section of data against the original handwritten notations.