Application: A collection of documents compiled by a pharmaceutical company or its agent in compliance with legislation and guidelines in order to seek a marketing authorization.
Attribute: See Properties.
Backbone: An XML document serving as a table of contents for a sequence. The backbone manages properties for an entire sequence and provides links to each document in the sequence. Technically, an eCTD contains two backbones – one for the regional (module 1) section and one for the ICH (modules 2 – 5) sections, but to a person viewing an eCTD, a harmonized view of the entire TOC is shown.
Checksum: A value used to ensure that data storage and transmission is authentic. Once data are received at the other end of a network, a new checksum is computed and matched against the existing checksum. A non-match indicates an error.
Context menu: The menu that is displayed when any item is right-clicked. The context menu shows menu items specific to the type of item selected. For example, men items are different when a sequence and a file reference are right-clicked.
Document Type Definition (DTD): Specifies the syntax of an XML file, including an allowable set of values for each element. DTDs define the structure of the sequence table of contents (see Backbone, above), allowable attribute values, and required and optional elements.
eAF: European XML electronic application form included in Module 1.
File Extension: A series of characters following the dot at the end of a computer file’s name, specifying the file’s format or purpose (such as .doc for a Microsoft Word document, .pdf for an Adobe® Portable Document Format file).
File Name: The file name is the name of the physical file associated with a file reference. Agency reviewers do not normally see this file name, but in some cases automated programs at agencies expect certain naming conventions to be followed.
File Reference: A file reference is an entry in the Table of Contents that provides a link to a file as well as additional information about the file. A file reference is also referred to as a Leaf Element.
Inter-Document Hyperlinks: Hyperlinks that lead to a location in another document. Also called external links.
Intra-Document Hyperlinks: Hyperlinks that lead to a location in the same document. Also called internal links.
Modified File Reference: See Properties.
Modifying File Reference: A file reference that is being replaced, appended to, or linked to by another file reference (generally a new file reference). It can (and probably should) have a Final state, since it is not being changed.
Properties: A file reference that replaces, appends to, or links to an existing file reference (generally a file reference that has already been submitted to a health authority). The modifying file reference must be editable (not have a Final state and in a containing folder reserved by the publisher making the change). The reason it must be editable is that it actually contains the information about the lifecycle operation being performed and points to the new content.
Published Output: Descriptive information about a sequence, section, Section (Node) Extension or file reference (leaf element/context of use). Properties of a sequence include information about submitting and receiving organization, manufacturer, publisher, ID and type of the submission, and related data items. Examples for properties on the file reference level include versioning information, language, and descriptive information such as document names, checksums, etc.
Published Output location: eCTD content including XML components and copies of the source documents.
Publisher: The official repository of the published sequence. When all sequence Quality Control is completed, this area will contain the final files and documents that will be submitted to a Regulatory authority and then archived in the official archiving location.
Publishing: User responsible for assembly and publishing of an electronic submission. Other responsibilities may include document preparation, hyperlinking, sequence QC, managing the review process, facilitating submission to an agency, and archiving.
Regulatory Activity: A Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information that will ultimately replace the eCTD standard.
Repeatable Section: A collection of sequences covering the start to the end of a specific business process, that normally results in an approval or rejection. Some examples are an original application, a supplement, or a Type II variation.
Reviewable Unit: See Regulatory Activity.
Section (Node) Extension: Section (Node) Extensions are a provision for extending the eCTD Table of Contents to a lower level than defined by the regulatory authorities by creating custom sub-sections. They are shown as extra headings in the eCTD structure.
Sequence: A single set of information and/or documents supplied by the applicant as a part of, or the complete, Application. A sequence always has a four digit sequence number.
Source Document: A document that has been prepared for inclusion in a sequence, but has not yet been transferred to the final Published Output location. Structured
Product Labeling: US XML label included in Module 1.
Study Tagging File (STF): ICH specification, implemented by the FDA and required for sequences received by the U.S. STFs provide meta-data on each study report currently not supplied by eCTD DTDs.
Table of Contents: The hyperlinked organizational structure of the eCTD. The TOC is created from the XML backbone.
Title: Identifies each file reference in the Table of Contents. This title is the primary means of identification for your document for an agency reviewer
Validation: Action taken to evaluate any technical errors in a sequence.
XML: Extensible Markup Language. XML is a markup language for documents containing structured information (such as headings, paragraphs, footnotes, and pictures). eCTD sequences include a number of XML elements which are created automatically by Publish, and may include XML documents as well.