Glossary Term Definition Reference Computer-based applications dealing with the EDMS management of documents throughout the document life cycle A formalized system of organizing and storing digital content such as documents, images, and other digital content items in an electronic record management system for clinical trials. The Term TMF encompasses eTMF documents related to strategies, methods, tools and personnel engaged throughout the lifecycle of the clinical trial regulated content. Items in a TMF may be required for compliance with government regulatory agencies. The eCTD is a global specification produced by the http://www.ich.org International Conference on Harmonisation (ICH) for eCTD electronic submissions of clinical trial data. It is used by regulatory agencies such as the US FDA and European Medicines Agency National Cancer Institute: is part of the National Institute of Health (NIH) and coordinates the U.S http://www.cancer.gov/ national Cancer program and conducts and supports NCI research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of Cancer. NCI Enterprise Vocabulary Service: provides http://evs.nci.nih.gov/ terminology content, tools, and services to code, NCI EVS analyze, and share cancer and biomedical research, clinical, and public health information. Presentation The presentation layer (or tier) in n-tier architecture is Layer the tier in which users interact with an application.
Glossary Term Definition Reference EDMS Computer-based applications dealing with the management of documents throughout the document life cycle eTMF A formalized system of organizing and storing digital content such as documents, images, and other digital content items in an electronic record management system for clinical trials. The Term TMF encompasses documents related to strategies, methods, tools and personnel engaged throughout the lifecycle of the clinical trial regulated content. Items in a TMF may be required for compliance with government regulatory agencies. eCTD The eCTD is a global specification produced by the International Conference on Harmonisation (ICH) for electronic submissions of clinical trial data. It is used by regulatory agencies such as the US FDA and European Medicines Agency http://www.ich.org NCI National Cancer Institute: is part of the National Institute of Health (NIH) and coordinates the U.S national Cancer program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of Cancer. http://www.cancer.gov/ NCI EVS NCI Enterprise Vocabulary Service: provides terminology content, tools, and services to code, analyze, and share cancer and biomedical research, clinical, and public health information. http://evs.nci.nih.gov/ Presentation Layer The presentation layer (or tier) in n-tier architecture is the tier in which users interact with an application.
eTMF-Committee-Specification-Draft-v02-Jan-15-2016.docx