Creating new form versions

When a form containing patient data changes after a trial has begun because of an approved protocol change or other sponsor request, sites use the new version of the form for as many trial patients as makes sense. For example, if a form change involves an additional item of data to collect, and the old version of the form has already been completed for a patient, a site does not attempt to collect the new data if it depends on a time that has already passed—for example, a blood draw that must occur one hour after the patient receives a dose of the trial drug. However, if the data item is not time-sensitive, a site generally tries to collect the item, and it requires the new version of the form to do so. This means that, when you create a new version of a form, you must consider whether multiple versions of the form will be needed under the same STUDYVERSION:

If a form change does not require sites to collect data from patients for whom the form has already been completed, revise the Form element, including additional or changed controls, Items, or Sections, as appropriate.
If a form change does require sites to collect data from patients for whom the form has already been completed, revise the Form element, including additional or changed controls, Items, or Sections, as appropriate. In the FORM definition, include the ALTREFNAME attribute to indicate that you are creating an alternate definition of an existing form. For information on creating an alternate version of a form, see Alternate versions of forms.

Changes made to Visit Reports and Regulatory Document forms are revised differently from the forms listed above. Since Visit Reports and Regulatory Document forms do not contain patient data, an audit trail of changes does not need to be maintained. Therefore, when a change is made to one of these forms, it is automatically reflected in all instances of the form and only one version of the form is preserved.