WA Validation 1.0 (Full) WA 1.0 en Full WA Validation Criteria v1.0 with additional recommended criteria. XML Backbones Identification 6.17.39 6.17.56 6.17.65 6.17.66 6.17.80 6.17.81 STF Identification 6.17.214 Folder name syntax must be correct 6.17.33 6.17.34 Folders must not be empty 6.17.62 No other files are allowed in Sequence root folder does not contain files unspecified files 6.17.37 Folder m1 exists and no files are placed there. 6.17.37 Folders m2, m3, m4 and m5 exist 6.17.37 Folder util exists and contained files are correct 6.17.8 6.17.38 6.17.46 6.17.47 6.17.55 6.17.57 6.17.58 6.17.178 6.17.402 Sequence folder should be four digits 6.17.30 Applications should start with sequence folder 0001 6.17.366 File name syntax must be correct 6.17.33 6.17.34 6.17.35 6.17.36 Unreferenced files are not allowed 6.17.37 File size limits should not be exceeded 6.17.21 6.17.22 6.17.23 File types (file extensions) check 6.17.9 6.17.44 6.17.45 Validation Report exists in Working Documents Folder 6.17.429 File index.xml must exist 6.17.39 The index.xml file must be valid 6.17.48 Attribute checksum-type 6.17.2 MD5 Checksum 6.17.7 MD5 for Index file 6.17.5 The reference to the DTD in index.xml is directed to the DTD provided in the util folder. 6.17.52 The files referenced by the cross reference (xlink:href) must exist 6.17.28 Only relative references are being used 6.17.29 References to targets outside application 6.17.206 References to targets outside Sequence 6.17.205 m1-administrative element must exist 6.17.211 Element must have leaf 6.17.19 Required Attribute value checks 6.17.212 Optional Attribute value checks 6.17.212 Leaf title must not be empty 6.17.25 Node Extension title must not be empty 6.17.25 Node Extension exists for all Clinical Studies 6.17.368 Node Extensions are appropriately placed 6.17.367 Missing Content in section 3.2.P 6.17.371 Multiple operations on the same document in the same Sequence are not allowed 6.17.209 Leaf operation attribute 6.17.13 6.17.26 6.17.27 6.17.42 6.17.207 Modified file existence 6.17.14 Use of Append 6.17.230 Detect invalid lifecycle pattern: Append operations causing branches 6.17.201 Detect invalid lifecycle pattern: Delete operations causing branches 6.17.201 Detect invalid lifecycle pattern: Replace operations causing branches 6.17.201 Detect invalid lifecycle pattern: Operation on deleted leaf content 6.17.200 Detect invalid lifecycle pattern: Append operations not appending to most recent STF leaf 6.17.210 Replace should not provide content identical to the previous file 6.17.208 File reuse (eCTD) 6.17.202 Module 1 (regional xml file) exists 6.17.39 The regional backbone file must be valid. 6.17.48 MD5 Checksum 6.17.7 Attribute checksum-type 6.17.2 The reference to the DTD in wa-regional.xml is directed to the DTD provided in the util folder. 6.17.52 The files referenced by the cross reference must exist 6.17.28 Only relative references are being used 6.17.29 References to targets outside application 6.17.206 References to targets outside Sequence 6.17.205 Leaf operations 6.17.13 6.17.26 6.17.27 6.17.207 6.17.42 Node Extension title must not be empty 6.17.25 Leaf title must not be empty 6.17.25 Element must have leaf 6.17.19 Leaf element must declare a language attribute for all Module 1 content 6.17.430 Node Extensions are appropriately placed 6.17.333 Multiple operations on same document in same Sequence are not allowed 6.17.209 Replace should not provide content identical to the previous file 6.17.208 Modified file existence 6.17.14 Use of Append 6.17.230 Detect invalid lifecycle pattern: Append operations causing branches 6.17.201 Detect invalid lifecycle pattern: Delete operations causing branches 6.17.201 Detect invalid lifecycle pattern: Replace operations causing branches 6.17.201 Detect invalid lifecycle pattern: Operation on deleted leaf content 6.17.200 Cover Letter operation attribute 6.17.181 General Note to Reviewer operation attribute 6.17.373 Lifecycle Management Tracking Table operation attribute - National Procedure 6.17.232 Lifecycle Management Tracking Table operation attribute - Reliance & Centralised Procedure 6.17.181 Application Form operation attribute 6.17.181 Fee Forms operation attribute 6.17.181 Summary of Product Characteristics operation attribute (including all subnodes) 6.17.232 Patient Information Leaflet operation attribute (including all subnodes) 6.17.232 Container Labels operation attribute (including all subnodes) 6.17.232 Foreign Labelling operation attribute (including all subnodes) 6.17.232 Reference Product Labelling operation attribute (including all subnodes) 6.17.232 Regional and International Regulatory Status operation attribute 6.17.232 File reuse (eCTD) 6.17.202 1.0.1 Cover Letter must exist 6.17.399 1.0.3 Lifecycle Management Tracking Table must exist 6.17.431 1.0.4 Correspondence Issued by the Regulatory Authority must exist if the Sequence Type is "Response" 6.17.400 1.0.5 Information Solicited by the Regulatory Authority must exist if the Sequence Type is "Response" 6.17.400 1.2.6 Electronic Declaration Document must exist 6.17.399 Provide Source Files for Product Information as 'New' 6.17.401 Provide Source Files for Product Information as 'Replace' 6.17.401 Envelope: recipient 6.17.432 Envelope: recipient (Attribute Code Validity) 6.17.433 Envelope: recipient (Multiple Recipients) 6.17.434 Envelope: application 6.17.375 Envelope: application (Attribute Code Validity) 6.17.376 Envelope: application-uuid 6.17.239 6.17.240 Envelope: lead-nmra 6.17.435 Envelope: lead-nmra (Attribute Code Validity) 6.17.436 Envelope: lead-nmra (Reliance) 6.17.437 Envelope: application-number 6.17.415 Application folder name must match application-number 6.17.377 Envelope: applicant-id 6.17.438 Envelope: applicant-name 6.17.439 Envelope: inn 6.17.440 Envelope: proprietary-name 6.17.387 Envelope: submission 6.17.389 Envelope: submission (Attribute Code Validity) 6.17.390 Envelope: submission (Submission Combination Validity) 6.17.391 Envelope: submission (Multiple Submissions in eCTD) 6.17.412 Envelope: submission baseline initial Sequence 6.17.213 Envelope: submission baseline supplemental information 6.17.441 Envelope: submission-lead 6.17.442 Envelope: submission-lead (Attribute Code Validity) 6.17.443 Envelope: submission-number 6.17.394 Envelope: sequence 6.17.395 Envelope: sequence (Attribute Code Validity) 6.17.396 Envelope: sequence-description 6.17.397 Envelope: sequence-date 6.17.398 Envelope: sequence-date (Not outdated) 6.17.369 Envelope: sequence-number 6.17.409 Sequence folder name must match Sequence Number from envelope 6.17.31 Envelope: related-sequence-number 6.17.372 Element related-sequence-number value 6.17.203 Sequence Type "Initial" references itself as related-sub unit-number 6.17.403 Envelope: contact 6.17.410 Envelope: contact (Attribute Code Validity) 6.17.411 Envelope: contact-name 6.17.414 Envelope: contact-email 6.17.374 Required documents 6.17.407 Expected documents 6.17.407 Possible documents 6.17.407 Check index reference 6.17.139 Check index reference (title match) 6.17.187 No backslash in xlink:href reference 6.17.186 STF leaf elements must reference other STF leaf upon append 6.17.183 STF cannot reference another STF 6.17.141 STF files must reference at least one leaf 6.17.140 Content Blocks are not accepted 6.17.106 Study Identifier category must not be empty 6.17.185 Study Identifier study-id must not be empty 6.17.132 Study Identifier title must not be empty 6.17.130 Categories and file tags 6.17.184 Category information must be provided for certain STFs 6.17.182 Invalid STF TOC location 6.17.135 STF doc-content file tag count 6.17.134 Study ID for STF must remain constant 6.17.138 Informational output about the number and total size of non E3 documents. 6.17.216 PDF documents must be readable 6.17.43 Bookmarks must be relative 6.17.15 Bookmarks with web or email destinations 6.17.89 Bookmarks to other external destinations (not web or email) are not allowed 6.17.88 Bookmarks with unknown actions are not allowed 6.17.87 Bookmarks must not be inactive 6.17.86 Bookmarks must not be broken 6.17.17 Bookmarks must not have multiple actions 6.17.85 Bookmarks must be 'Inherit Zoom' 6.17.63 Bookmarks should exist in all larger documents 6.17.281 Hyperlinks must be relative 6.17.15 Hyperlinks to other external destinations (not web or email) are not allowed 6.17.88 Hyperlinks with unknown actions are not allowed 6.17.87 Hyperlinks must not be inactive 6.17.86 Hyperlinks must not be broken 6.17.17 Hyperlinks must not have multiple actions 6.17.85 Hyperlinks must 'Inherit Zoom' 6.17.63 Hyperlinks with web or email destinations 6.17.89 PDF documents should not have any security settings 6.17.40 PDF is not an unallowed version 6.17.18 PDF version must be correct 6.17.18 PDF documents must not be password protected 6.17.40 PDF documents with attachments are not allowed 6.17.84 PDF initial view must be correct 6.17.10 6.17.11 6.17.12 PDF should have 'Fast Web Access' active 6.17.16 PDF documents with annotations 6.17.83 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 value for ID attribute must start with a letter or underscore character. 6.17.20 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 same Sequence Number is not already used in the application (including folder name) 6.17.32 Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version. 6.17.41 Ensure that one and only one index-md5.txt file exists and is placed in the correct location (i.e. <app-id>\<seq-num>\index-md5.txt) 6.17.53 The system shall ensure that index MD5 txt file is named correctly (i.e. index-md5.txt) 6.17.54 Ensure that all files and folders in the submission are accessible to the user 6.17.64 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 hyperlinks and/or bookmarks in the submission documents does not target document outside current eCTD application 6.17.69 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 child element 'title' is not provided in the doc-content of the STF files in the submission 6.17.109 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 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 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 valid STF DTD version (e.g. dtd-version = "2.2") is referenced in the STF XML file 6.17.143 Ensure that valid STF DTD version (e.g. version = "STF Version 2.2") is listed in the index.xml file for stf leaf element 6.17.144 Ensure that STF DTD version in stf xml file (i.e. dtd-version = "2.2") must match the stf dtd version specified for the stf leaf in index.xml file (i.e. version = "STF Version 2.2") 6.17.145 Ensure that STF DTD version (e.g. dtd-version = "2.2") is specified in the STF XML file 6.17.146 Ensure that STF DTD version (e.g. version = "STF Version 2.2") is specified in the index.xml file for stf leaf element 6.17.147 Ensure that stf xml file is not cumulative information. 6.17.148 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 operation attribute is present and valid value ('new', 'append', 'replace' or 'delete') for the attribute is provided 6.17.180 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 all element in the submission backbone xml files must have leaf child nodes 6.17.204 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 only one dataset of each type (filename configured) referenced in an STF is marked as 'new' operation. This is applicable for Module 4 and Module 5. 6.17.259 Ensure that hyperlinks must exist in these nodes, namely, 1.3.1 SmPC, 1.0.5 Response and 1.2.3 Certificate (COA, CEP, etc.) 6.17.492 Ensure that the Submission Type 'Baseline' and Sequence Description 'Initial' are used for the first baseline sequence. 6.17.493 Ensure that the values for Application Type, Recipient, and Lead Evaluating NMRA are mutually consistent. 6.17.494