CDISC Questionnaire

Name

Email Address

Company

Phone

How do you manage your Metadata standards? How do you manage your Metadata standards? Spreadsheet MDR Outsource Operational systems (e.g. EDC, SCE) Collaboration space (e.g. Wiki, SharePoint) Other

What is the scope of your data standards? (check all that apply) What is the scope of your data standards? (check all that apply) Protocol CDASH/Collection STDM ADaM TFL Other

What challenges do you face managing data standards? (check all that apply) What challenges do you face managing data standards? (check all that apply) Governance Versioning Impact Analysis Availability (accessible, usable, searchable) Other

How do you govern your standards? How do you govern your standards? Manually (e.g. weekly exception request meetings) Automated (e.g. issue tracking system)

What is the scope of data standards governance? What is the scope of data standards governance? Global Therapeutic area Indication Study Clinical trial phase

Does your organization have a dedicated data standards group? If Yes, which department does that sit in? Does your organization have a dedicated data standards group? If Yes, which department does that sit in? Yes No Data management Biostats Stat programming Clinical development IT Other