Designing a research database management system.

For a Perinatal-20 study, many data were to be collected over an extended period. A system for managing the data was needed so that the integrity of the data, and the quality of the research based on the data, could be ensured from the study’s start. More than 60 types of data collection forms were designed. To monitor a subject’s progress through the treatment program, some forms were collected at multiple time points. Data from more than 45,000 forms were entered throughout the course of this 5-year study.