631 - We have a Enrollment Form for a PSP program that has been previously approved by PAAB. We have a PDF writeable format which we would like our PSP Field Case Managers ( Nurses) to send to our HCPs via email. Could you please provide any limitations or requirements to this, if any?

  • A direct transfer of a print APS to an electronic platform does not in and of itself, render the piece subject to re-review. Allowing the form fields that were intended to be filled out by the physician to be open text fields would be acceptable. However, having a drop down menu with options would render it subject to a new review. Consider if there are formatting changes required to meet the specifications of the new platform. Reformatting a print APS onto an electronic platform often means there is new functionality added to the piece (i.e. links, modifiable fields, etc.). The PAAB should be informed of any electronic functionality which is added to the Enrollment Form. Also, in this particular example, as the Enrollment Form will be distributed by email, a subject line is required. These additions/revisions to the previously approved piece require PAAB review of the electronic format.