e CTD Workshop February 26 2004 1 e

e. CTD Workshop February 26, 2004 1

e. CTD Specifications • e. CTD Backbone files (document file information) – Module 1 (us-regional. xml) – Module 2 to 5 (index. xml) – Study Tagging File • Comprehensive table of contents headings and hierarchy and mapping • Other – Study data – Submission transmission 2

Document File Information • Subject matter – title, table of contents headings • Relationship to other files – ties together files for a single report • Life cycle – new, replace, append, delete • Location – file path • Submission information – application number, submission number. . . 3

Index. xml • Modules 2 to 5 • Elements – Heading element – Leaf element • ID - unique identifier • operation - life cycle • Modified-file - ID of previously submitted leaf effected by operation attribute • Checksum and checksum-type • xlink: href - location of file using file path • title - title of document 4

Heading Element • CTD Table of contents headings • Rules – Some heading elements have no leaf elements – Some heading elements include an attribute for further organization of files – Don’t include headings if it does not have any files • Additional heading elements and organizing attributes found in us-regional. xml and study tagging files 5

Leaf Element - ID Attribute • ID + application number + sequence number = unique identifier • letter + number – valid “a 12345” – not valid “ 12345” 6

Leaf Element - Operation Attribute • Values – new - no effect on any file leaf in a previously submitted e. CTD backbone file – append - information in addition to file in a leaf in a previously submitted e. CTD backbone file – replace - file replaces a file in a leaf in a previously submitted e. CTD backbone file – delete - file contained in a leaf in a previously submitted e. CTD backbone file should no longer be considered in the evaluation 7

Leaf Element Modified-file Attribute • Location of leaf being modified – Relative path and filename for the e. CTD backbone file containing the modified file’s leaf element – Example file submitted in sequence number 0000 replaced • modified-file=". . /0000/index. xml#id 12345 " 8

Leaf Element - xlink: href Attribute • Path of file associated with the leaf relative to index. xml file – xlink: href="m 5/tabular-listing-studies. pdf " 9

Leaf Element - Title Attribute • Title of file that is meaningful to reader 10

us-regional. xml • Module 1 • Admin element – applicant-info element • company-name element • date-of-submission element – product-description element • application-number element • prod-name element and type attribute – application-information element and type attribute • submission element and submission-type attribute • sequence-number element • related-sequence-number element • Leaf and Heading elements 11

Study Tagging File • Supplements the document file information included in the index. xml file – Relationship to other files • Links files for a single report together – Subject matter • Study report title • Study grouping (e. g. , species, placebo control) • Additional headings (e. g. , synopsis) 12