Overview

Trial forms and the corresponding user documentation are typically revised from time to time. After making the revisions to the forms and user documentation, you incorporate the changes into the trial by updating the STUDYVERSION and STUDYVERSIONDOC tags that describe the configuration of the trial. Then, as each site is ready to use the new version, you cut over the site by updating its STUDYVERSIONSITE tag. You make all of these revisions by editing the appropriate XML files and installing the new files by using the MedML Installer tool.

Note: When you revise a control, you cannot change its data type.

This system of controlling versions preserves a record of each version of the trial and the forms that comprised it. It also allows you to cut over sites selectively. That way if the changes require site approval, the new version can be activated as each site grants its approval.