September 2018 Internal Review Posting Announcement

Sept 10, 2018 – 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>; 
• 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 the following 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:

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

1. Hospital Anxiety and Depression Scale (HADS)
2. Hamilton Anxiety Rating Scale (HAM-A)
3. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0) Supp V1.0
4. Symptoms of Major Depressive Disorder Scale Version 1.0 (SMDDS v1.0) Supp V1.0

In addition, the following 18 supplements, all part of the PEDSQL V3.0 Neuromuscular Module, are now entering the internal review period:

1. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 CHILD PARENT REPORT v1 Approved
2. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 CHILD v1 Approved
3. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 TEEN PARENT REPORTv1 Approved
4. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 TEEN v1 Approved
5. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 TODDLER PARENT REPORTv1 Approved
6. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG ADULT PARENT REPORT v1 Approved
7. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG ADULT v1 Approved
8. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG CHILD PARENT REPORT v1 Approved
9. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE ACUTE V3 YOUNG CHILD v1 Approved
10. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 CHILD PARENT REPORT v1 Approved
11. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 CHILD v1 Approved
12. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 TEEN PARENT REPORTv1 Approved
13. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 TEEN v1 Approved
14. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 TODDLER PARENT REPORTv1 Approved
15. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 YOUNG ADULT PARENT REPORT v1 Approved
16. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 YOUNG ADULT v1 Approved
17. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 YOUNG CHILD PARENT REPORT v1 Approved
18. SDTM QS Supplement - QRS PEDSQL NEUROMUSCULAR MODULE V3 YOUNG CHILD v1 Approved

Reviewers are requested to provide comments via JIRA, or if s/he does not have any comments, to 'Like' the supplement at the bottom of the 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.

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.