Revising without updating the study version

For most trial definition changes, creating a new study version is strongly advised. However, from time to time you may find that you need to make minor cosmetic changes to a form and would prefer not to create an entirely new version of the trial. For example, you may want to correct a typographical error on a form, or change the position of a caption.

For these types of changes, the following method is available. In this method, you apply changes directly to the current version of a form. Because the form version does not change, the study version does not need to be updated. You can make changes to the following trial component definitions in this way:

Section—by using the UPDATE_FORM_SECTION MedML tag
Item—by using the UPDATE_SECTION_ITEM MedML tag

Any changes completed using this method must be re-applied manually on all destination machines after migration.

The impact of such changes should be tested thoroughly against existing patient data as well as new patient data.

Note: Making trial definition changes without creating a new study version violates Good Clinical Practice (GCP), and can cause problems with trial data. Be sure you understand the consequences of making changes this way before you implement those changes in a live trial. This method should never be used to change the datatype of a control or remove an existing control from an item especially if that item contains previously entered data.