GC Validation 1.4 (Full) GC 1.4 en Full GC Validation Criteria v1.4 with additional recommended criteria. The specified filename is used 6.17.57 The file is placed in the correct folder 6.17.57 A currently acceptable version of the DTD is used (checksum matches the published value) 6.17.46 The specified filename is used 6.17.58 The file is placed in the correct folder 6.17.58 The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence 6.17.55 The specified filename is used 6.17.57 The file is placed in the correct folder 6.17.57 A currently acceptable version of the DTD is used (checksum matches the published value) 6.17.47 The specified filename is used 6.17.57 The file is placed in the correct folder 6.17.57 The checksum for the 'gc-leaf.mod' file used must match the published checksum for the 'gc-leaf.mod' file associated with the DTD used for the sequence 6.17.47 The specified filename is used 6.17.57 The file is placed in the correct folder 6.17.57 The checksum for the 'gc-envelope.mod' file used must match the published checksum for the 'gc-envelope.mod' file associated with the DTD used for the sequence 6.17.47 The specified filename is used 6.17.58 The file is placed in the correct folder 6.17.58 The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence 6.17.55 The file is placed in the correct folder 6.17.39 The file is named correctly 6.17.56 The file is well formed 6.17.48 The file is valid 6.17.48 The reference to the DTD in index.xml is directed to the DTD provided in the util folder 6.17.52 The reference to the stylesheet in index.xml is directed to the stylesheet provided in the util folder 6.17.51 The file is placed in the correct folder 6.17.53 The file is named correctly 6.17.54 The regenerated checksum for the index.xml matches the value in the file 'index-md5.txt' 6.17.5 The file is placed in the correct folder 6.17.39 The file is named correctly 6.17.56 The file is well formed 6.17.48 The file is valid 6.17.48 The reference to the DTD in 'gc-regional.xm'l is directed to the DTD provided in the util folder 6.17.52 The reference to the stylesheet in 'gc-regional.xml' is directed to the stylesheet provided in the util folder 6.17.51 The leaf attribute "checksum-type" has a value of md5 or MD5 6.17.2 The regenerated checksum for each file matches the value in the leaf attribute "checksum" 6.17.7 For every leaf the "title" attribute is not empty 6.17.25 All leaves with an operation attribute value of new, replace or append must have a value for the cross reference (xlink:href) 6.17.27 All leaves with an operation attribute value of delete must have no value for the cross reference (xlink:href) 6.17.26 The file referenced by the cross reference (xlink:href) must exist in the same or a previously submitted sequence within the same eCTD application 6.17.28 All leaves with an operation attribute value of replace, delete or append must have a value for modified-file 6.17.13 All leaves with an operation attribute value of new must have no value for modified-file 6.17.42 The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application 6.17.14 The sequence folder name is a 4 digit number 6.17.30 The sequence number (folder name) has not already been used 6.17.32 The sequence folder name matches the sequence number in each envelope in 'gc-regional.xml' 6.17.31 There are no unreferenced files in m1, m2, m3, m4 and m5 folders 6.17.37 The only files in the sequence folder (/XXXX/…) are the index.xml and index-md5.txt 6.17.37 If the procedure type in the envelope should be "gcc" or "national" 6.17.50 Individual files do not exceed 100 MB in size 6.17.21 Only valid characters are used in folder names 6.17.34 Only valid characters are used in file names 6.17.34 The files provided in the folders for Module 2-5 are in acceptable formats 6.17.44 The files provided in the folders for Module 1 are in acceptable formats 6.17.44 For Modules 1-5: The folder structure and names must follow the GCC or ICH defined structure and names. 6.17.49 For Module 1: The file names must follow the GCC defined names. 6.17.49 The submission does not contain corrupted files 6.17.43 Total file folder path length must not exceed 180 characters 6.17.35 Folder names must not exceed 64 characters 6.17.33 File names, including the extension, must not exceed 64 characters 6.17.33 Hyperlinks and Bookmarks within the same sequence have a valid target 6.17.17 6.17.69 Hyperlinks and Bookmarks to destinations in a different sequence in the same eCTD have a valid target 6.17.17 6.17.69 All hyperlinks and bookmarks are set to "inherit zoom" 6.17.63 All PDF bookmarks are relative 6.17.15 Fast Web View must be enabled for existing PDFs 6.17.16 If the submission unit type is "additional-info" or "correction" then the related-sequence attribute must have a value 6.17.250 If the submission unit type is not "additional-info" or "correction" then there must not be related sequence attribute 6.17.249 If the submission unit type is "reformat" the submission type should be "none" 6.17.248 Ensure that 'checksum' attribute is present and value for the attribute is provided (i.e. not empty string) when 'operation' attribute for the leaf(s) is 'new', 'append' or 'replace' 6.17.3 Ensure that 'checksum' attribute value is not provided when 'operation' attribute for the leaf(s) is 'delete' 6.17.4 Ensure that invalid formatting is not provided for 'checksum' in index-md5.txt (32 characters are not specified for the MD5 checksum, or included trailing spaces or carriage returns) 6.17.6 Ensure that the checksum of the DTD for STFs provided in the util folder must match the checksum value provided by the agency 6.17.8 Ensure that all files must have one and only one file extension 6.17.9 Ensure that the bookmark pane is visible ('initial view' of the document is set to 'Bookmarks Panel and Page') when the pdf document contains bookmark(s) 6.17.10 Ensure that the bookmark pane is not visible ('initial view' of the document is set to 'Page Only’) when the pdf document does not contain bookmark(s) 6.17.11 Ensure that all PDF files open in "most recent view" (i.e. 'inherit zoom for bookmarks and links, 'default' in open dialog box (ICH eCTD Specs p7-4), and "Page Layout = Default" and "Magnification = Default") 6.17.12 Ensure that pdf version number is valid (only 1.4 or 1.5 or 1.6 or 1.7) for all PDF documents in the submission 6.17.18 Ensure that all lowest level heading elements included in the submission (index and regional xml file - section, node extension and/or nested node extensions) must contain one leaf 6.17.19 Ensure that value for ID attribute must start with a letter or underscore character 6.17.20 Allow users to configure file size limit for special file types (i.e. xpt). For all other file types (where configuration is not specified), default max file size value in the 'Check for File Size' field shall be used for validation 6.17.23 Ensure there is no reference leaf(s) point to a file (outside of the eCTD lifecycle) across application (xlink:href points to a different application) 6.17.24 Ensure that the xlink:href and/or modified-file attribute conforms to the eCTD standard (valid characters - no backslash '\', colon':', asterisk'*', question mark'?', less than'<', greater than'>', pipe'|', or space ' ', file path relative to the backbone xml files and includes file name in the path) 6.17.29 Ensure that 'util' folder exists and is in the correct location (<sequence number>/util) 6.17.38 Ensure that there is no security setting or password protection (i.e. certificate security, owner password set or adobe policy server settings and All ‘restrictions’ should be ‘allowed’ when viewing Document Preferences-->Security settings) to access and open any files in the submission This validation excludes files in Section 1.0, 1.2, 3.3, 4.3 and 5.4 6.17.40 Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version 6.17.41 Ensure that there no empty folders in the submission (i.e. folders without files or subfolders) 6.17.62 Ensure that all files and folders in the submission are accessible to the user 6.17.64 Ensure that the ICH DTD versions used in the current sequence (sequence being tested) is equal to or higher than the DTD version used in the numerically preceding sequence of the application 6.17.65 Ensure that the regional DTD versions used in the current sequence (sequence being tested) is equal to or higher than the DTD version used in the numerically preceding sequence of the application 6.17.66 Ensure that all hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008 (link path must not contain back slash, only forward slash is allowed, links must not be made with Java script code) 6.17.67 Ensure that the ICH DTD version used in the current sequence (sequence being tested) is equal to or lower than the DTD version used in the numerically succeeding sequence of the application 6.17.80 Ensure that the regional DTD version used in the current sequence (sequence being tested) is equal to or lower than the DTD version used in the numerically succeeding sequence of the application 6.17.81 Provide list of all documents in the submission containing annotation (other than links and bookmarks) 6.17.83 Ensure that all pdf documents in the submission must not have any attachments 6.17.84 Ensure that all hyperlinks and bookmarks in the submission documents must not have multiple actions (e.g. opening two different pages) 6.17.85 Ensure that all hyperlinks and bookmarks (internal, external, same sequence, across sequences and across applications) in the submission documents are not inactive (without any action) 6.17.86 Ensure that all hyperlinks and bookmarks in the submission documents must not have unknown action (links that could not be identified or contain JavaScript code) and print total count 6.17.87 Ensure that all hyperlinks and bookmarks in the submission documents must not point to external destinations (other than web or email) 6.17.88 Ensure that all hyperlinks and bookmarks in the submission documents must not point to web address or email 6.17.89 Print the count of all of the hyperlinks and the bookmarks with following criteria: - Non-Relative Hyperlinks - Non-Relative Bookmarks - Web link and email hyperlinks - Web links and email bookmarks - External Hyperlinks (excluding web links and emails) - External Bookmarks (excluding web links and emails) - Unknown Action Hyperlinks - Unknown Action Bookmarks - Inactive Hyperlinks - Inactive Bookmarks - Broken Hyperlinks (separate count for inter-application, intra-application and intra-sequence) - Broken Bookmarks (separate count for inter-application, intra-application and intra-sequence) - Number of bookmarks per document - Total number of bookmarks in the submission - Number of hyperlinks per document - Total number of hyperlinks in the submission 6.17.90 Ensure that the link and/or bookmark destination does not point to a corrupt document 6.17.91 Ensure that the links and/or bookmark in the submission documents point to an existing page and/or named destinations. 6.17.92 Ensure that 'property' element (if present) is listed before its sibling 'file-tag' element in all of the stf files of the submission. 6.17.107 ensure that 'property' element is present in all of the stf files in the submission created with STF DTD v2.0 only 6.17.108 Ensure that child element 'title' is not provided in the doc-content of the STF files in the submission 6.17.109 Ensure that an STF xml file is referenced in a submission only once 6.17.129 Ensure that 'title' element (within 'study-identifier') is present and value for title is provided in the STF xml file 6.17.130 Ensure that STF files are not missing in the submission (i.e. xlink:href contains ‘stf-xxxxxxxx.xml’ but system is not able to locate the file) 6.17.131 Ensure that STFs (files named as ‘stf-xxxxxxxxx.xml’) in the submission contain study-id information (element and the value is not empty) and reference leafs 6.17.132 Ensure that STF title (within study-identifier element) in the stf xml file matches with the leaf title for the stf in the index.xml file 6.17.133 Ensure that one and only one doc-content file-tag is specified for each file referenced in the STFs. 6.17.134 Ensure that STF is only referenced in the sections of M4 and M5 allowed as per the STF specification 6.17.135 Ensure that STF’s in the submission are named correctly based on the naming convention i.e. ‘STF-<study-id>.xml’ 6.17.136 Ensure that STFs in the submission have valid file extension (file extension is not missing and it is .xml) 6.17.137 Ensure that lifecycle stf must have the same study-id as the original stf (referenced by the modified-file) 6.17.138 Ensure that files referenced by an STF exist in the submission/application (referenced by index.xml) 6.17.139 Ensure that STF file must reference at least one leaf element 6.17.140 Ensure that an STF file does not reference another STF file 6.17.141 Ensure that files in study sections are referenced by an STF 6.17.142 Ensure that valid STF DTD version (e.g. dtd-version = "2.2") is referenced in the STF XML file. 6.17.143 Ensure that 'title' element of the 'leaf' and/or 'node-extension' does not begins or ends with a space 6.17.167 Ensure that valid/supported 'dtd-version' is referenced in the ICH and regional backbone xml files 6.17.170 Ensure that 'dtd-version' is referenced in the ICH and regional backbone xml files 6.17.173 Ensure that required attributes (e.g. 'indication' in the section 5.3.5 element or 'type of control' in the STF XML file for a study in section 5.3.5.1) are present in the back bone xmls (index and regional) and in the heading element of STF XML file(s) 6.17.176 Ensure that attribute (i.e. substance, company-name, species) values in ICH, regional and/or STF backbone files does not begins or ends with a space 6.17.177 Ensure that non-required files are not present in the util folder (i.e. submission does not have an stf or leaf but the stylesheet and dtd files are present in the util folder) 6.17.178 Ensure that operation attribute is present and valid value ('new', 'append', 'replace' or 'delete') for the attribute is provided 6.17.180 Ensure that 'operation' attributes for cover letter and application form leaf must be 'new' 6.17.181 Ensure that 'category' information must be provided for STFs in following sections: • 4.2.3.1 Single dose toxicity section contains 'species' and 'route-of-admin'. • 4.2.3.2 Repeat dose toxicity section contains 'species', 'route-of-admin', and 'duration' (if applicable). • 4.2.3.4.1 Long term [carcinogenicity] studies contain 'species'. • 5.3.5.1 Study reports of controlled clinical studies pertinent to the claimed indication contain 'type-of-control’. 6.17.182 Ensure that 'modified-file' of lifecycle stf must point to a stf (e.g. not a pdf document) 6.17.183 Ensure that 'file-tag' values and 'category' values are valid as per the 'valid-values.xml' file referenced by the submission 6.17.184 Ensure that value for study-identifier/category element must not be empty 6.17.185 Ensure that 'xlink:href' attribute of a leaf referenced in an STF must exists and must not contain backslashes 6.17.186 Ensure that the titles from the doc-content elements (if present) must match the corresponding leaf title values in the ICH backbone 6.17.187 Ensure that 'append' operation is not applied on an existing lifecycle 'append' leaf (E.g. Detect invalid life cycle pattern: sequence 0001 appends a document in sequence 0000, sequence 0002 append operation leads to the append in 0001.) 6.17.199 Ensure that leaf lifecycle operation ('append', 'replace' or 'delete') is not applied to a lifecycle 'delete' leaf (E.g. sequence 0001 deletes a document in sequence 0000, sequence 0002 any life cycle operation leads to the already deleted leaf in 0001.) 6.17.200 Ensure that a leaf is not lifecycled ('append', 'replace' or 'delete') by more than one leaf to cause branching (i.e. scenario where a append/replace/delete operation is being applied on a leaf, which has already been replaced by another leaf. E.g. sequence 0001 replaces a document in sequence 0000, sequence 0002 append operation leads to the already replaced leaf in 0000.) 6.17.201 Ensure same xlink:href is not referenced more than once in the backbone xml files 6.17.202 Ensure that all element in the submission backbone xml files must have leaf child nodes 6.17.204 Ensure that xlink:href attribute in backbone xml files does not point to leaf outside current sequence 6.17.205 Ensure that 'xlink:href' attribute in backbone xml files does not point to leaf outside application 6.17.206 Ensure that only operation 'new' is used for all leafs in the initial sequence of the application 6.17.207 Ensure multiple lifecycle operations on same document in same sequence are not allowed (E.g. sequence 0001 includes two lifecylce operations referencing the same leaf in sequence 0000.) 6.17.209 Ensure that most recent stf (stf that was lifecycled last instead of previous or original stf) is lifecycled 6.17.210 Ensure attribute (if present i.e. indication, excipient, dosage-form, manufacturer, product-name, substance etc.) value must not be empty string 6.17.212 Ensure that the initial sequence of the application must be '0000' 6.17.213 Identify and report all invalid STF files. STF files with an incorrect name will be also reported 6.17.214 Ensure that the sequence being validated is the highest sequence in the application 6.17.217 Ensure that the reference for the regional xml backbone file in index.xml must have operation attribute value 'new' 6.17.219 Ensure that 'm1' folder must exist in the submission 6.17.220 Ensure that there is a stylesheet declaration in backbone xml files (index, regional and STF) 6.17.229 Ensure that the sequence numbers in an application are increased incrementally (The sequence number related to the life cycle should increase incrementally with each subsequent submission, for example 0000, 0001, 0002 etc. (the increase should occur in chronological order) 6.17.238 Ensure that TS.xpt is present in STF for module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 and in module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 6.17.255 Ensure that only one dataset of each type (filename configured) referenced in an STF is marked as 'new' operation Note: This is applicable for : Module 4 : section 4.2.3.1, 4.2.3.2, 4.2.3.4 Module 5: section 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 6.17.259 Ensure PDF documents with more than 10 pages must have bookmarks 6.17.281 Ensure Cover letter is required for GC region 6.2.7.11 Ensure leaf can only be added in either m1-5-1 or m1-5-2 section 6.2.7.11