MedML tags for trial updates

A STUDYVERSION tag represents all of a trial’s forms and formsets at a particular point in time. Each time forms change, or are added or dropped, a new study version must be prepared to incorporate the changes into the trial definition. Study versions are identified by a VERSIONDESCRIPTION attribute. The attribute is simply a key that you assign to uniquely identify the version.

A study version also has a corresponding document set, represented by the STUDYVERSIONDOC tag. This tag lists all the documentation files that apply to a version identified by a particular VERSIONDESCRIPTION value.

Study versions (and study version docs) are mapped to trial sites using the STUDYVERSIONSITE tag. The STUDYVERSIONSITE tag specifies the current version active at a site. This allows you to control the version in use on a site-by-site basis. The cutover to a new version occurs when the STUDYVERSIONSITE for the site is processed by the MedML Installer.