THE SAFTEE-GI AND SAFTEE-SI FORMS WERE DEVELOPED AT THE NATIONAL INSTITUTE OF MENTAL HEALTH FOR THE PURPOSE OF COLLECTING INFORMATION ON ADVERSE HEALTH EVENTS OCCURING DURING CLINICAL TRIALS.

THE SAFTEE-GI AND SAFTEE-SI FORMS WERE DEVELOPED AT THE NATIONAL INSTITUTE OF MENTAL HEALTH FOR THE PURPOSE OF COLLECTING INFORMATION ON ADVERSE HEALTH EVENTS OCCURING DURING CLINICAL TRIALS. INVESTIGATORS ARE BEGINNING TO RECORD DATA WITH THESE PROCEDURES. 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. WE PROPOSE TO DEVELOP COMPUTER SOFTWARE WHICH 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 THEY WISH. DURING PHASE I WE 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, WE WILL MODIFY THE PROGRAMS AND DEMONSTRATE THEM AGAIN. WE WILL MAKE THE SOFTWARE AVAILABLE TO ANY INVESTIGATORS WHO WISH TO USE IT. DURING PHASE II WE EXPECT TO PUBLISH A USERS' MANUAL AND OFFER SHORT TRAINING COURSES FOR COMPUTER OPERATORS. IN CASE THERE ARE SOME INVESTIGATORS WHO PREFER TO SEND THEIR SAFTEE FORMS TO A CENTRAL FACILITY RATHER THAN DOING THE DATA PROCESSING THEMSELVES, WE WILL BE PREPARED TO OFFER THAT SERVICE. AS USERS GAIN KNOWLEDGE THEY WILL THINK OF NEW WAYS TO ANALYZE ADVERSE EVENT DATA. WE WILL ADD ENHANCEMENTS TO THE SOFTWARE IN ORDER TO MEET THEIR NEEDS.