This discussion paper is issued with the intention of convincing
eHealth designers (government sponsored initiatives) and providers of
technology to support these nationwide initiatives ...
CDISC updates this page regularly with announcements from the regulatory authorities, however readers should check for new announcements directly with the agency concerned.
- The PMDA recently announced the release of the English version of the Notification on Practical Operations, Q&A and the Technical Conformance Guide for electronic study data submission in Japan are now available. Please note that the names of the notifications in English is changed from those used in some previous presentations by PMDA.
- Advanced Review with Electronic Data Promotion Group
- Notification on Practical Operations of Electronic Study Data
- Question and Answer Guide Regarding Notification on Practical Operations of Electronic Study Data Submissions
- Technical Conformance Guide on Electronic Study Data Submissions
- PMDA Data Standard Catalog
- A new document about CDER Data Standards has been posted on the FDA website. Please click here to access to document directly.
- EMA released the Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials as 'adopted' on 1 August 2010. This references the eSDI Document.