Internal Review Announcement was sent to the following:

Lists:

FDA:  

CDISC:

Dear CDISC Community,

The SDS Questionnaires, Ratings, and Scales Sub-team is pleased to announce that eight supplements are now entering the internal review period. All supplements are located on the CDISC Wiki at https://wiki.cdisc.org/display/QRSSUPP/Internal+Review and listed below:

  1. Draft SDTM RS Supplement - ATLAS v1 Public Domain
  2. Draft SDTM FT Supplement - Emotion Recognition v1 Approved
  3. Draft SDTM QS Supplement - LEC-5 STANDARD VERSION v1 Public Domain
  4. Draft SDTM FT Supplement - MMSE-2 STANDARD VERSION v1 Approved
  5. Draft SDTM QS Supplement - SIQ v1 Approved
  6. Draft SDTM QS Supplement - SIQ-JR v1 Approved
  7. Draft SDTM QS Supplement - TSCC v1 Approved
  8. Draft SDTM RS Supplement - VALG v1 Public Domain

We strongly encourage organizations that actively use these instruments to review the supplements at this point in the development process.

We plan to close this review period on 14 August 2018.

Reviewers are requested to provide comments via JIRA; or if there are not comments, to 'Like' the Wiki page. Detailed instructions for reviewing the document can be found here: Instructions for Reviewers.

To set up access to our WIKI/JIRA (wiki.cdisc.org and jira.cdisc.org), self-register at http://wiki.cdisc.org/signup.action. Once registered, forward this email to wikijiraadmin@cdisc.org to ensure the correct access. Please copy the Team Lead/Project Manager on the forwarded email.

Thank you in advance for your time in reviewing and commenting on these supplements. 

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  1. Internal Review: 30 July - 14 August 2018.