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WorksheetsCLPT BP804 ET eCTD
Total questions: 10
Worksheet time: 7mins
What is eCTD?
Electronic Common
Technical Document
Electronic Common
Technical Dossier
Electrical Common
Technical Document
Elected Common
Technical Document
Which module of ICH deals with guidelines of eCTD?
M8
M4
Q2
S3
What is XML Based eCTD?
extensible markup language Document Type Definition)
extra markup language Document Type Definition)
extensible makeup language Document Type Definition)
extra makeup language Document Type Definition)
The eCTD submission is composed of the following?
All
Content files
XML eCTD instance
Directory structure
The common formats that can be included in an eCTD submission are?
All
Narrative: Portable Document Format (PDF)
Structured: Extensible Markup Language (XML)
Graphic: Whenever possible, use PDF. When appropriate or when PDF is not possible, use Joint
Photographic Experts Group (JPEG), Portable Network Graphics (PNG), Scalable Vector Graphics
(SVG), and Graphics Interchange Format (GIF)
CTD cross-references can be supported in the eCTD through the use of ______?
hyperlinks
JPEG
Word File
The eCTD is designed around the concept of a backbone. The backbone is similar to a container that holds
pointers (called leaf elements) to the files that are part of the submission. The backbone is based on an
XML Document Type Definition (DTD)?
True
False
May be
The file that is produced based on the XML eCTD DTD is the eCTD XML instance or XML backbone?
True
False
May be
SVG is a language for describing two-dimensional graphics in XML. SVG allows for three types of
graphic objects: vector graphic shapes (e.g., paths consisting of straight lines and curves), images, and
text?
True
False
May be
What is the Electronic Mail Contact for US FDA to know format and content of the regional requirements of each
module?
esubprep@fda.hhs.gov
www.fda.gov/cder
esubmission@emea.europa.eu
ereview@hc-sc.gc.ca
