April 2018 Internal Review Posting Announcement

Internal Review Announcement was sent to the following:

Lists:

• 'adam@lists.cdisc.org';
• 'adqrs@lists.cdisc.org';  (ADaM QRS Sub-team)
• 'cdash@lists.cdisc.org';
• 'sds@lists.cdisc.org';      
• sds_sdtm_qs@lists.cdisc.org';  (SDS QRS Sub-team)
• 'send@lists.cdisc.org';
• 'pgx@lists.cdisc.org';
• 'ggg@lists.cdisc.org';
• 'terminology_all@lists.cdisc.org';

FDA:  

• COADataStandards@fda.hhs.gov

CDISC:

• Rhonda Facile<rfacile@cdisc.org>; 
• Lauren Becnel <lbecnel@cdisc.org>; 
• Julie Chason <jchason@cdisc.org>; 
• Diane Wold <diane.wold@cdisc.org>
• Ann White <awhite@cdisc.org>

Dear Reviewers,

The SDS Questionnaires, Ratings, and Scales Sub-team is pleased to announce that ten supplements (see below) are now entering the internal review period:

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

1. The Draft SDTM QS Supplement - CES v1 Public Domain: SDTM QS Supplement - CES v1 Public Domain
2. The Draft SDTM QS Supplement - PCL-5 v1 Public Domain: PTSD Checklist for DSM-5 (PCL-5)
3. The Draft SDTM QS Supplement - CGI GUY v1 Public Domain: SDTM QS Supplement CGI GUY v1 Public Domain
4. The Draft SDTM QS Supplement - CGI v1 Public Domain: Clinical Global Impression (CGI) 2019-03-20
5. The Draft SDTM QS Supplement - PGI v1 Public Domain: Patient Global Impression (PGI) 2019-03-20
6. The Draft SDTM FT Supplement - 4 Stair Ascend v1 Public Domain: 4-Stair Ascend (4-STAIR ASCEND) Supp V1.0
7. The SDTM FT Supplement - 4 Stair Descend v1 Public Domain: 4-Stair Descend (4-STAIR DESCEND) Supp V1.0
8. The SDTM FT Supplement - Rising From Floor v1 Public Domain: Rising From Floor (RISING FROM FLOOR) Supp V1.0
9. The SDTM FT Supplement - Ten Meter Walk/Run v1 Public Domain: 10-Meter Walk/Run (10-METER WALK/RUN)
10. The SDTM FT Supplement - MMSE v1 Approved: SDTM FT Supplement - MMSE v1 Approved

Reviewers are requested to provide comments via JIRA. 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.

We plan to close this review period on two weeks from posting date.

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