SG Validation 1.1 (Full) SG 1.1 en Full SG Validation Criteria v1.1 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 HTML Rendition of Regional Backbone 6.17.451 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 Sequence Root folder does not contain unspecified files 6.17.37 Folder m1 exists and no files are placed there. 6.17.37 Only folders m2, m3, m4, m5 and util 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 6.17.178 6.17.402 Sequence folder should be four digits 6.17.30 Applications should start with sequence folder 0001 6.17.213 6.17.366 First Sequence to a Submission must be an Initial 6.17.506 File name syntax must be correct 6.17.33 6.17.34 6.17.35 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 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 Extensions are appropriately placed 6.17.367 Node Extension title must not be empty 6.17.25 Node Extension or STF exists for all Clinical Studies 6.17.368 Node Extension naming convention for content provided in 5.3.6 6.17.370 Node Extension elements in 3.2.R 6.17.347 Node Extension naming convention for content provided in 3.2.R 6.17.347 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 6.17.207 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 ICH File reuse 6.17.202 Missing Content in section 3.2.S 6.17.371 Missing Content in section 3.2.P 6.17.371 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 Schema in sg-regional.xml is directed to the Schema 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 Element must have leaf 6.17.19 Leaf title must not be empty 6.17.25 Node Extensions are appropriately placed 6.17.333 Node Extension title must not be empty 6.17.25 Nested Node Extensions 6.17.495 Multiple operations on same document in same Sequence are not allowed 6.17.209 Leaf operations 6.17.13 6.17.26 6.17.27 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 Replace should not provide content identical to the previous file 6.17.208 Regional File Reuse 6.17.202 Cover Letter operation attribute 6.17.181 Note to Evaluator operation attribute 6.17.181 Outer Carton Labels operation attribute (including all subnodes) 6.17.232 Inner/Blister Labels operation attribute (including all subnodes) 6.17.232 Package Insert operation attribute (including all subnodes) 6.17.232 Patient Information Leaflet operation attribute (including all subnodes) 6.17.232 Singapore-Specific Annex operation attribute 6.17.232 Reference RMP operation attribute 6.17.232 Educational/RMP Materials operation attribute (including all subnodes) 6.17.232 1.0.1 Cover Letter must exist 6.17.399 1.0.4 Response to Input Request must exist if the Sequence Type is 'Response' 6.17.400 Provide New Source Files 6.17.401 Only Module 1 content allowed in Closing Information sequences. 6.17.404 No Module 3 content allowed for Submission Type MAV2 6.17.405 Provide at most ONE document per sequence per the SG-HSA M1 Granularity Annex 6.17.408 Envelope: application 6.17.375 Envelope: application (Attribute Code Validity) 6.17.376 Envelope: application-number 6.17.415 Envelope: application-number (match submission-number) 6.17.496 Envelope: sg-ectd-id 6.17.497 Envelope: sg-ectd-id must be identical to the Application Folder name 6.17.498 Envelope: inn 6.17.379 Envelope: product-type 6.17.380 Envelope: product-type (Attribute Code Validity) 6.17.381 Envelope: product-type DMF (Appropriate Submission Types) 6.17.382 Envelope: dmf-number 6.17.383 Envelope: dmf-number provided when DMF content included 6.17.384 Envelope: pmf-number 6.17.385 Envelope: pmf-number provided when PMF content included 6.17.386 Envelope: proprietary-name 6.17.387 Envelope: sin-number 6.17.388 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 DMF (Appropriate Product Type) 6.17.393 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-sequence-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 and prohibited documents 6.17.407 Expected documents and documents that should not be provided 6.17.407 Possible documents 6.17.407 Check index reference 6.17.139 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 Cumulative STF files are not allowed 6.17.148 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 with destinations outside repository root folder are not allowed 6.17.88 Bookmarks must not have multiple actions 6.17.85 Bookmarks must not be inactive 6.17.86 Bookmarks must not be broken 6.17.17 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 with destinations outside repository root folder are not allowed 6.17.88 Hyperlinks must not have multiple actions 6.17.85 Hyperlinks must not be inactive 6.17.86 Hyperlinks must not be broken 6.17.17 Hyperlinks must 'Inherit Zoom' 6.17.63 Hyperlinks must exist in Response documents 6.17.274 Hyperlinks with web or email destinations 6.17.89 PDF documents should not have security settings which prevent copying or printing 6.17.40 PDF documents must not be password protected to open 6.17.40 PDF version must be correct 6.17.18 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 modified-file attribute is not present and/or value for the attribute is not provided when the leaf operation of the file is 'new' 6.17.42 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 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). The system shall include in the message the name of the file containing hyperlinks and/or bookmarks that are not according to the ISO 32000-1:2008 specification. 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 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 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. Message shall include the file name/title of the stf which does not match with leaf title. 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 '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 for each dataset (filename configured) type there is only one leaf referenced in an STF is of operation type 'new'. 6.17.259