Glossary

Document Type Definition (DTD)

A DTD defines the structure and the legal elements and attributes of an XML document. In particular, the XML eCTD DTD (Document Type Definition) defines the overall structure of the submission. The purpose of the XML backbone is two-fold: (1) to manage meta-data for the entire submission and each document within the submission and (2) to constitute a comprehensive table of contents and provide corresponding navigation aids. Meta-data on submission level include information about submitting and receiving organization, manufacturer, publisher, ID and kind of the submission, and related data items. Examples for meta-data on document level are versioning information, language, descriptive information such as document names and checksums.

Source: ICH M2 EWG Electronic Common Technical Document Specification

Resources

Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.

Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

Found 370 Results
Page 1 of 2































Arm

















































































































































ICH






























































































































Page 1 of 2