Any interested community member may comment on a draft CDISC standard. For each project, a list of targeted reviewers is developed to ensure robust and adequate review.

Comment Submission

Comments are submitted via the CDISC JIRA issue tracker. In this stage, it is important to identify the regulatory experts. Input received from these experts should be acknowledged and carefully managed. If input from a FDA Liaison is not carried through in the document, the Project Manager should directly communicate the decision to the expert commenter. The Clinical Expert assists in this communication and the FDA Liaison should be asked to acknowledge this communication.

Duration of Comment Period

The duration of the public review comment period is 60 days. The project team determines if the number of comments received is sufficient. The project team consults with the SRC if too few comments are received. At the conclusion of the public review comment period, the draft standard is removed from the CDISC website and all comments are archived by the CDISC Wiki/JIRA Administrator.