Alternate versions of forms

From time to time during a trial, the contents of a form may change to accommodate a protocol revision or a need for clarification. In general, if a patient has started a CRF when a new CRF version is implemented, the original CRF is retained. Any patients who have not started the CRF use the new form. This is a logical approach when the data collected on a CRF depend on measurements and observations taken at a specific visit.

However, there may be occasions when it is desirable to collect additional data retrospectively, when the data are not specifically visit dependent. For example, the sponsor may decide to collect additional family history data after a patient has completed the intake visit where that data might most logically be recorded. In such a case, you can create an alternate version of a form for the additional data to be collected, and include the form in the visit where the data would have been collected originally. For patients who have started the original version of the form, both the original and the alternate form are presented, and the new data can be collected on the alternate version of the form.