The SAFTEE-GI and SAFTEE-SI forms were developed to collect information on adverse health events occurring during clinical trials. Investigators are beginning to record data with these forms. A system is needed for entering information from the forms into a computer, storing it on magnetic media, and retrieving and summarizing the information in meaningful ways.The investigators propose to develop computer software that will accept adverse event data rapidly and accurately from a keyboard, store the information efficiently on diskettes or fixed disks, and make it easy for scientists to retrieve and analyze the data whenever desired.During Phase I the investigators will confer with developers and users of the SAFTEE forms, select suitable computer hardware, draw up detailed specifications for the required programs, and write the programs. The complete hardware and software system will be tested and demonstrated to users. As a result of their comments, the programs will be modified and demonstrated again. The researchers will make the software available to any investigators who wish to use it.During Phase II the investigators expect to publish a user's manual and offer short training courses for computer operators. As users gain knowledge, they will think of new ways to analyze adverse event data. Enhancements will be added to the software to meet their needs.National Institute Of Mental Health
