Box 88 Features of an appropriate clinical trials software package

♦ Simple to set up the database for a new trial rapidly in-house

♦ Flexible, allowing changes to be made to the structure with safeguards against inadvertent changes

♦ Includes automatic schedule checking and detection of missing data, and is capable of generating letters reminding clinicians when a form is due and giving details of problems

♦ Capable of handling the large amounts of data associated with multi-centre trials, particularly randomized phase III trials

♦ Accommodates longitudinal data involving several types of follow-up form

♦ Can handle large numbers of repeated variables as are involved, for example, in quality of life studies

♦ Allows the rapid interactive entry and correction of data, the merging of data, and the specification of repeated blocks of variables

♦ Includes detailed checks for the consistency and accuracy of data

♦ Maintains a list of data inconsistencies together with the status of any queries and the action taken

♦ Assists day-to-day trial administration

♦ Produces displays and printed listings required for interim analyses, data review and site visits

♦ Permits multi-user access. This is valuable for very large or complex trials in which different parts of the database may be monitored, updated or analysed by different users or centres

♦ Permits remote data entry

♦ Permits import and merging of data from external sources or databases

♦ Exports to common statistical packages

♦ Should allow a full audit trail that tracks all data entry and changes to be done

0 0

Post a comment