CDISC invites you to submit comments on the following supplements to the Study Data Tabulation Model Implementation Guide (SDTMIG)
- Clinical Global Impressions (CGI) Questionnaires Supplement to the SDTMIG (SDTMIG QS Supplement - CGI v1 Public Domain)
- Patient Global Impressions (PGI) Questionnaires Supplement to the SDMTIG (SDTMIG QS Supplement - PGI v1 Public Domain)
Timelines and Comment Process
- The public review period is 30 days. The deadline for submitting comments is 30 Oct 2018.
- The draft documents can be found here:
- SDTMIG QS Supplement - CGI v1 Public Domain - https://wiki.cdisc.org/display/QRSSUPP/SDTM+QS+Supplement+-+CGI+v1+Public+Domain
- SDTMIG QS Supplement - PGI v1 Public Domain - https://wiki.cdisc.org/display/QRSSUPP/SDTM+QS+Supplement+-+PGI+v1+Public+Domain
- Instructions for providing comments: https://wiki.cdisc.org/display/QRSSUPP/Public+Review+Instructions+for+Reviewers
CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all. Public review is a key quality step in the development of a standard.
Comments will be addressed following the public review period. Decisions made and actions taken will be documented and communicated to the public.
Thank you for contributing your time and expertise.
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