Do I need to include a template of a case report form in the submission of a new application?

Documents (besides the protocol and Investigator Brochure) that are not distributed to patients and are not source documents need not to be submitted to JPEC as JPEC do not review documents those documents. However, the applicant is still allowed to submit a copy of those documents (i.e JPEC acknowledges the submission) but an approval will not be issued as it did not undergo a review.