REFERENCES & RELATED DOCUMENTs Related Documents Reference Document Name Filename No. Guidance for Industry. Providing Regulatory [FDA1] Submissions in Electronic Format — Standardized Study Data - DRAFT GUIDANCE . February 2012 [CDISC1] CDISC Glossary - 2009 [ISO1] ISO1179 - Accessible on ISO site ISO/IEC 11179 Metadata Registry (MDR) standard [ISO2] ISO2109 Accessible on ISO site (draft version ISO 21090 Healthcare Data Type Standard available on Internet) Status Name Company Date Signature Author Author Author Author Appendices CDISC glossary
REFERENCES & RELATED DOCUMENTs Related Documents Reference No. Document Name Filename [FDA1] Guidance for Industry. Providing Regulatory Submissions in Electronic Format — Standardized Study Data - DRAFT GUIDANCE . February 2012 [CDISC1] CDISC Glossary - 2009 [ISO1] ISO1179 - ISO/IEC 11179 Metadata Registry (MDR) standard Accessible on ISO site [ISO2] ISO2109 ISO 21090 Healthcare Data Type Standard Accessible on ISO site (draft version available on Internet) Status Name Company Date Signature Author Author Author Author Appendices CDISC glossary