News Archiv

US: New version of CDISC Glossary, Strategy 2010 published

CDISC released a new version of their Clinical Research Glossary and their list of Acronyms, Abbreviations and Initials. Both documents are available for download in PDF format as...[more]

US: CDISC releases ADaM 2.1 and ADaMIG 1.0

CDISC announced the posting of the Analysis Data Model Version (ADaM) 2.1 and the Analysis Data Model Implementation Guide Version (ADaMIG) 1.0.  

Please note that the...[more]

US: CDISC publishes XML Schema Validation for Define.xml

A XML Schema Validation for Define.xml has been released as white paper in version 1.0 by CDISC. This white paper provides guidance on validating define.xml version 1.0 documents...[more]

US: FDA released new version 1.5 of the Study Data specification

A new version 1.5 of the Study Data specification has been released by the FDA. The update includes

Modified introductionAdditional specifications for submitting data tabulation...[more]

US: FDA releases new version of their ESG user guide

An updated version of the user guide for the Electronic Submission Gateway (ESG) has been released by the FDA.

The new version has the version date 2009-10-23 an is available...[more]

US: FDA publishes new version of the draft Guidance regarding technical Q&A to SPL

A new revision (revision 1) of the draft Guidance for Industry has been published by the FDA dealing with technical questions & answers regarding the use of Structured Product...[more]

US: FDA publishes updated transmission specifications for eCTD submissions

In this new version (v1.2) of the transmission specification for electronic submissions following changes were introduced

Removal of Media Type Floppy DiskUpdated Linear Tape...[more]