Completed by:

Dana Booth Steve Kopko

Date Completed:

 

Name and Version of Project:

Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)


BEFORE POSTING FOR PUBLIC REVIEW

  • All internal review comments have been resolved and updated in JIRA.  
  • Supplement has been through copy-editing.  
  • The FDA priority list has been checked to see if the supplement is marked "yes".  
    • Not an FDA Priority
    • If the supplement is an FDA priority, it has gone through FDA review and additional copy-editing if there were extensive changes.
  • The FDA disclaimer is in the supplement if they reviewed it and not in the supplement if it's not an FDA priority.
  • Notify the SDS QRS Subteam that the supplements are ready for public review.
  • Announcement has been prepared.
  • Project Manager/Team Lead notified Ann White (Communications) at least 5 days before planned public review posting so she can review the announcement and post to the CDISC website.


BEFORE SENDING FOR NEXT STEPS PUBLICATION

  • All public review comments have been resolved in JIRA.  If not, note above, do not put a check by the supplement name, and do not send on for the publication (will need to complete a separate public review checklist).
    • Once all IR and PR comments are approved, mark them as "Done", export to Excel, and archive on the supplement archive page.
  • Information boxes have been removed from supplement.
  • All text is black except for links (which are blue).
  • DRAFT or REVISION DRAFT has been changed to FINAL in document metadata.
  • Revision History date and status has been updated.
  • Supplement has been through final copy-editing step.
  • The FDA priority list has been checked to see if the supplement is marked "yes".
    • If the supplement is an FDA priority, it has gone through FDA quick review and additional copy-editing if there were extensive changes. This was identified to be a FDA COA instrument and will go thru FDA internal review before publishing.
  • Notify the SDS QRS Subteam that the supplements are ready for the publication stage.
  • Announcement has been prepared.
  • Project Manager/Team Lead notified Alana and Ann White (Communications) at least 5 days before planned posting to prepare for publication and posting to the CDISC website.

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