Definitions

Term Description
Artifact Name Identifies the tertiary level of classification for a document. The Artifact Name is a subset of the Domain Name.
Checklist (Trial, Country, Site) A list of documents that must be obtained for the specified Milestone.
Clinical eTMF Content Type Provides a link between the Clinical eTMF User Interface and the Clinical eTMF features
Clinical Trial Workspace A site collection, dedicated to a specific clinical trial that houses all of the trial specific information.
Column Name The internal column identifier that is used by the system.
Content Type List Identifies the content types and column relationships along with the column properties and associated lookup parameters if appropriate.
Domain Name Identifies the highest level of classification for a document.
Document Inventory List Uses the Domain, Group and Artifact to determine which template and parent content type to assign, where the document is to reside, whether to apply an autoname schema.
electronic Common Technical Document (eCTD) An interface for the pharmaceutical industry to agency transfer of regulatory information.
electronic Trial Master File (eTMF) A computer based system consisting of TMF documents stored in an electronic format.
Group Name Identifies the secondary level of classification for a document. The Group Name is a subset of the Domain Name.
HUB The master site collection that houses all lists, templates, etc. that are common to all clinical trials.
NextDocs Filtered Lookup Identifies a column as a multiple layer lookup column such that when the highest level value is selected, the secondary level will be filtered based upon the first level value, etc. If only one value is available based upon previous selections, that value will be auto selected.
NextDocs Smart Document A NextDocs feature that facilitates new document creation.
NextDocs Template Library Library that houses all templates referenced in the Document Inventory List
Show Summary Provides a link to a popup window that will display a summary of the document properties based upon the selected categories on the Clinical eTMF UI.
Study Milestones A list of phases that a clinical trial will pass through from start to finish.