Investigators testing new drug applications were recording information about a patient’s condition on confusing and disorganized forms. As a result, investigators’ entries were often inconsistent, illegible, and incomplete. Data entry personnel made frequent errors when deciphering and interpreting the entries, requiring costly, time-consuming follow-ups.

The forms were redesigned using more white space, clearer headings, and more prompts. Because the new forms are less cluttered, they can be more easily completed, scanned for completeness, and reviewed. In addition, a modular system of forms tailored to record testing of new drugs was created.