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Completed by:@name
Date Completed:

 (update date)

Name and Version of Project:name of/link to supplement(s) going for internal review.


BEFORE POSTING FOR INTERNAL REVIEW

  • Approval from the SDS QRS Subteam has been obtained.
  • The FDA disclaimer has been inserted if confirmed to be an FDA priority or removed if confirmed not to be.  (If the FDA is uncertain, remove the FDA disclaimer for internal review.)
  • Supplement met all requirements on the Developer & Quality Control Review Checklist for SDS QRS Supplements
  • The Developer & Quality Control Review Checklist for SDS QRS Supplements has been added as a child page to the supplement wiki page.
  • The QRS Public Domain Copyright Verification Document has been attached to the supplement wiki page.
  • The instrument name has been added to the components in the QRSSUPP Jira project. NEW CHECKLIST ITEM
  • Announcement has been prepared.
  • Project Manager/Team Lead notified Ann White (Communications) at least 3 days before planned internal review posting so she can review the announcement and post to the CDISC website

    Once all items have been checked in the above list, and Ann has approved the announcement, the supplement is ready for internal review.  After internal review, the following checklist should be completed:

CLOSING THE INTERNAL REVIEW COMMENT PERIOD

  • Moved internal review supplements to Between IR and PR
  • Project Manager/Team Lead assigned comments from the Wiki to team members (all comments submitted via spreadsheet or other means should be entered as JIRA issues)
  • Project Team resolved internal review comments, and updated the draft document in the Wiki

    If applicable (see tip below if not applicable):
  • Project Manager/Team Lead notified the Education Team of the target date for the public review posting and webinar presenters
  • The Education Team scheduled the draft standard as a topic for the monthly public webinar that is closest to the public review release date


If an item has been left unchecked, add a note after the item as follows:

  1. Place the cursor at the end of the item.
  2. Hit return.
  3. Tab in and add a note.
  4. Check the new note instead of the item that is not applicable.

    For example:
    • Project Manager/Team Lead notified the Education Team of the target date for the public review posting and webinar presenters
      • N/A; No webinar is scheduled at this time.


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