CA Validation 5.3 (Full) CA 5.3 en Full CA Validation Criteria v5.3 with additional recommended criteria. Checks the sequence folder structure for any empty folders (folders without any files or subfolders).

6.17.62

Checks the sequence folder structure for any files or folders the user does not have access permission to.

6.17.64

This rule's implementation checks for files that exceed the configured maximum size. Warning for PDF files between 150 MB and 200 MB. Warning for other file types larger than 100 MB (excluding SAS XPT).

6.17.252

This rule's implementation checks for files that exceed the configured maximum size (Max. size: 200 MB for PDF, 1 GB for SAS XPT).

6.17.21

6.17.23

Checks the sequence folder name. Furthermore the rule will report a finding if the sequence seems to be the initial sequence for the application but its name is not 0000.

6.17.213

Reports error if the validated sequence is not the highest in the application folder.

6.17.217

Identifies all ICH and regional index files found in the sequence folder. Incorrect or invalid index files will be reported as errors.

6.17.65

6.17.66

6.17.176

Identifies all STF files found in the sequence folder. Invalid STF files will be reported as errors. STF files with an incorrect name will be also reported as errors

6.17.214

Each subsequent transaction provided in the lifecycle of a dossier, must have a sequence number that is consecutively incremented by 1 number (for example 0000, 0001, 0002, 0003, and so on). Skipping numbers is not acceptable for sequence numbers. Validating a transaction with sequence number 0004 will report an error if sequence number 0003 does not exist (even if sequence 0004 does not have any reference to it).

6.17.238

Word document will be reported as corrupted or password protected if one or more of the following situations occur: Document is corrupt or unreadable;Document has password protection;Document references an attached template located via http or https;Document is empty. Note: This rule applies only to Word version 2007 or later (.docx).

6.17.328

6.17.330

This rule checks if the eCTD sequence that is being validated already exists in the eCTD dossier.

6.17.32

A PDF document will be reported as corrupt if one or more of the following situations occur: 1. The document cannot be opened because it is damaged.; 2. The document appears to have 0 pages.;3. The document appears to be an application form, but the form content cannot be read.;4. The document contains additional data (more than 1024 characters) after the last %%EOF (End Of File). An example of situation number (3) could be a document appearing to have 1 page only and the page contains the text phrase "Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document."

6.17.43

6.17.331

6.17.342

Retrieves all non-relative bookmarks in PDF documents and prints the total count, including the broken ones.

6.17.15

Retrieves all web link bookmarks and e-mail bookmarks in PDF documents and prints the total count.

6.17.89

Retrieves all external bookmarks other than web links and e-mail links from PDF documents and prints the total count.

6.17.88

Retrieves all inactive bookmarks in PDF documents and prints the total count.

6.17.86

Retrieves all broken inter-application bookmarks in PDF documents and prints the total count.

6.17.17

Retrieves all broken intra-application bookmarks in PDF documents and prints the total count.

6.17.17

Retrieves all broken intra-sequence bookmarks from PDF documents and prints the total count.

6.17.17

Retrieves all unknown bookmarks (links that could not be identified or contain JavaScript code) from PDF documents and prints the total count.

6.17.87

Reports the number of bookmarks per document and the total number of bookmarks in the sequence.

6.17.90

Retrieves all non-relative hyperlinks from PDF documents and prints the total count, including the broken ones.

6.17.15

Retrieves all web links and e-mail links from PDF documents and prints the total count.

6.17.89

Retrieves all external hyperlinks other than web links and e-mail links from PDF documents and prints the total count.

6.17.88

Retrieves all inactive hyperlinks from PDF documents and prints the total count.

6.17.86

Retrieves all broken inter-application hyperlinks from PDF documents and prints the total count.

6.17.17

Retrieves all broken intra-application hyperlinks from PDF documents and prints the total count.

6.17.17

Retrieves all broken intra-sequence hyperlinks from PDF documents and prints the total count.

6.17.17

Retrieves all unknown hyperlinks (links that could not be identified or contain JavaScript code) from PDF documents and prints the total count.

6.17.87

Reports the number of hyperlinks per document and the total number of hyperlinks in the sequence.

6.17.90

Finds PDF documents with password protection.

6.17.40

Checks all PDF document versions against the list of allowed versions.

6.17.18

Finds all documents with an owner password set, excluding Health Canada application forms regardless of their location in module 1 and literature references in subfolders: 33-lit-ref, 43-litref, 54-lit-ref.

6.17.40

Finds all encrypted documents.

6.17.218

For all bookmarks, the named destination or destination page will be verified. Non existing destinations will be reported (i.e. the destination file exists but the page does not).

6.17.92

Finds all bookmarks with multiple actions assigned.

6.17.85

For all hyperlinks, the named destination or destination page will be verified. Non existing destinations will be reported (i.e. the destination file exists but the page does not).

6.17.92

Finds all hyperlinks with multiple actions assigned.

6.17.85

This rule is configured to detect attachments and portfolio documents found in PDF documents.

6.17.84

All bookmarks and hyperlinks should have a magnification setting of "Inherit Zoom". This rule performs the corresponding checks for bookmarks.

6.17.63

All bookmarks and hyperlinks should have a magnification setting of "Inherit Zoom". This rule performs the corresponding checks for hyperlinks.

6.17.63

Checks for PDF documents with an incorrect initial view. ICH eCTD Specification: Documents with bookmarks must show the bookmarks pane in their initial view. The Magnification and Page Layout should be set as "default".

6.17.10

6.17.11

6.17.12

PDF documents with more than 10 pages must have bookmarks. Excluded from this check are literature references in sections 3.3, 4.3, and 5.4; the life cycle management table; and Health Canada application forms regardless of their location in module 1.

6.17.281

Finds all documents where printing is not allowed.

6.17.295

Finds all documents where copying the content is not allowed.

6.17.296

This rule checks for PDF files that contain, dynamic content (e.g., audio, video or special effects), or 3D content. Health Canada application forms are excluded from this check regardless of their location in module 1.

6.17.305

This rule checks for PDF files that contain JavaScript. Health Canada application forms are excluded from this check regardless of their location in module 1.

6.17.305

Document contains images only and is not text searchable.

6.17.93

Checks for broken links in submission files. Hyperlinks targeting files outside the application will be identified.

6.17.206

Checks for broken links in submission files. Hyperlinks targeting files outside sequence will be identified.

6.17.205

This check option refers to the current sequence. It will perform a general verification of the leaf life cycle properties in this sequence only (no deep history scanning). For leaf elements with operation "new", the eValidator verifies that: modified file must not exist / title is given / href must exist.;For leaf elements with operation "replace", the eValidator verifies that: modified file must exist / title is given / href must exist.;For leaf elements with operation "append", the eValidator verifies that: modified file must exist / title is given / href must exist.;For leaf elements with operation "delete", the eValidator verifies that: modified file must exist / title is not required / href must not exist.; The eValidator verifies that for initial submissions all leaf elements have the operation "new". The eValidator checks modified files in LCM: leaf in previous sequence must exist. It also verifies that when the attribute "modified-file" has been used for a leaf document then the referenced document exists in the previous submission. It is recognized that this attribute is invalid when used for submission sequence number 0000.The eValidator checks that all files referenced in the backbone exist.

6.17.13

6.17.14

6.17.26

6.17.27

6.17.28

6.17.42

6.17.207

The eValidator regenerates the MD5 checksums for all referenced files and compares the checksums to the values provided in the backbone file.

6.17.7

Checks the syntax of all referenced file names (path length, illegal characters, etc.). The maximum path length is 230 characters.

6.17.33

6.17.34

6.17.35

The eValidator checks that only relative references (href and modified file) are used. Also, only forward slashes "/" are allowed (no backslashes). Do the file references in the index files (ICH, Regional, STF) use relative paths? Absolute (i.e. rooted) paths are not allowed.

6.17.29

Searches for files not referenced in an index file (ICH, Regional or STF).

6.17.37

Rule compares the checksums of the DTD and schema against the following checksums: ich-ectd-3-2.dtd: 1d6f631cc6b6357f0f4fe378e5f79a27;ca-regional-2-2-.xsd: ff564d6e69adebd9a9b4f274e65cf5f1;xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5;xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a;ich-stf-v2-2.dtd: 0972c10a4dadf3df5d2f41b2026a4a5c

6.17.8

6.17.46

6.17.47

The eValidator checks for "node-extension" elements being used and reports them for informational purposes.

6.17.168

MD5 checksums for index files will be calculated and compared against the MD5 checksums provided in the MD5 text files (not case sensitive).

6.17.5

Performs XML validation for ICH Backbone and Regional backbones. Uses the DTD or Schema given in the sequence number folder (util/dtd).

6.17.48

Checks if referenced files have exactly one file extension.

6.17.9

Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'.

6.17.204

The sequence folder must have a subfolder m1 with a subfolder ca.

6.17.222

The folder m1\ca must not have any subfolders.

6.17.222

For operations other than 'delete', all leafs must have a 'title' child. The title must be present.

6.17.221

6.17.25

The regional backbone ca-regional.xml file must exist in folder m1\ca.

6.17.39

The element value for the dossier-identifier must match the name of the parent folder of the sequence folder. And the dossier-identifier must start with the letter e or s.

6.17.163

Refer to the Regulatory Transaction Descriptions document available upon request on the Filing Submissions Electronically. Applies only to Clinical Trial Application (CTA), Clinical Trial Application – Amendment (CTA-A), Pre-Clinical Trial Application Meeting (pre-CTA), and Development Safety Update Report (DSUR).

6.17.191

Cover letter should have 'new' operation attribute.

6.17.181

Checks for documents in the regional backbone, which are used as modified-file more than once.

6.17.209

Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence).

6.17.202

When replacing content, the new content should be different from the previous content. This check does not apply to image files provided in module 1.

6.17.208

6.17.44

Detect invalid life cycle pattern: Delete operations causing branches.

6.17.201

Detect invalid life cycle pattern: Replace operations causing branches.

6.17.201

Detect invalid life cycle pattern: Operation on deleted leaf content.

6.17.200

The value of the sequence-number element must match the sequence folder name.

6.17.31

The operation attribute for this leaf element must be “new” when provided for the first time, and “replace”/ “delete” whenever referenced again as part of a subsequent transaction.

6.17.251

Element values product-name and applicant must not be empty.

6.17.226

6.17.227

Cover letter should not have more than three pages.

6.17.328

6.17.332

Node extensions in module 1 backbone (ca-regional.xml) are not allowed, except in 1.2.6 Authorization for Sharing Information heading, 1.2.7 International Information heading, and 1.6.1 Comparative bioavailability Information heading. The validator checks all headings and subheadings in the Canadian regional backbone (ca-regional.xml). It generates an error when there is (are) node extension(s) found in any subheadings other than those mentioned above This rule does not apply to leaves with operation "delete".

6.17.333

Node extensions are expected in section 1.2.7 International Information heading. Note: There is a mixture of node extensions and leaves allowed in the 1.2.7 International Information heading. A warning is generated when there is a (are) leaf (leaves) added under this heading. The warning serves the purpose to notify the user to manually verify the leaves added under this heading. Requirements are outlined below and will result in failure of the transaction if not followed: When provided, the International Status document and the Foreign review attestation must be added as leaves directly under 1.2.7 subheading. Any other foreign agency (such as FDA,. EMA) related documents must be provided using node extensions This rule does not apply to leaves with operation "delete".

6.17.334

For node extensions, the title child must be present (value must be present).

6.17.25

The use of operation “append” is not allowed in module 1.

6.17.343

Checks if referenced files have exactly one file extension.

6.17.9

The checksum-type attribute must have the value md5 or MD5.

6.17.2

Checks if the attribute value is present.

6.17.212

Checks if the attribute value is present.

6.17.212

Checks if the attribute value is present.

6.17.212

Checks if the attribute value is present. Applicable only to sections where this attribute is mandatory, otherwise reported as warning.

6.17.212

Checks if the attribute value is present.

6.17.212

Checks if the attribute value is present. Applicable only to sections where this attribute is mandatory, otherwise reported as warning.

6.17.212

Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'.

6.17.204

The index.xml file must be present.

6.17.39

The MD5 checksum file index-md5.txt must be present.

6.17.53

The m1 folder must be present.

6.17.220

The util folder must be present.

6.17.38

For operations other than 'delete', all leafs must have a 'title' child. The title must be present.

6.17.25

The element m1-administrative-information-and-prescribing information must be present.

6.17.211

The m1 folder must not have any other files in addition to the files explicitly allowed.

6.17.37

The root folder (sequence number folder) must not have any other files in addition to the files explicitly allowed.

6.17.37

For node extensions, the title child must be present (value must be present).

6.17.25

Regional backbone(s) referenced (ca-regional.xml) should have 'new' operation attribute.

6.17.219

Checks for documents in the ICH backbone, which are used as modified-file more than once.

6.17.209

Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence).

6.17.202

Valid file extensions include: Documents:.pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx;Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp;Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg;Coding Language:.xml,.xsl,.xsd,.dtd;Data, Modeling and Simulation:.dat,.inf,.txt,.sas,.xpt, .wksz,.wksx,.wks (SimCyp workspace files, Pharmaceutical Drugs only), .sdax,.edpdp,.wsp,.epr,.pnf, .psf, .sprx (Lot Release Program for Schedule D drugs, Biologic Drugs only), .mdb, .pbk, .dsd, .opd, .spd, .mdd, .ipd, .zfd, .cdd, .crd, .psd, .tpd, .efd, .itd, .stc, .psa, .beq, .ivc, .cat, .iap, .imp, .iop, .dlp, .plp, .ocp (GastroPlus files, Pharmaceutical Drugs only)

6.17.44

When replacing or appending content, the new content should be different from the previous content.

6.17.208

The number of leaves directly under a single node must not exceed 1000. This rule applies only to module 5 when using node extensions and only to leaves with operation attribute "new".

6.17.282

Detect invalid life cycle pattern: Append operations causing branches.

6.17.201

Detect invalid life cycle pattern: Append operations not appending to most recent STF leaf.

6.17.210

Detect invalid life cycle pattern: Delete operations causing branches.

6.17.201

Detect invalid life cycle pattern: Replace operations causing branches.

6.17.201

Detect invalid life cycle pattern: Operation on deleted leaf content.

6.17.200

Detect invalid life cycle pattern: Append on Append.

6.17.199

Do not provide strength values in the dosage form attribute in sections 2.3.P, 3.2.P, 3.2.A.1, or 3.2.A.2. Any numeric value found in these attribute values will be reported as an error. If the strength value was already present in a previous sequence, the rule will not report an error for the current sequence.

6.17.283

This applies to leaf elements in the ICH sections modules 2-5. When revisions are sent to a regulatory authority, the new leaf element should be submitted in the same location in the backbone as the leaf element being appended, replaced or deleted.

6.17.82

This check will examine the SAS XPT dataset files (XPORT). Files that are corrupt or compressed will be reported as Error. For details about the technical specifications, please refer to the FDA study data technical conformance guide.

6.17.335

Leaf elements in 3.2.R Regional Information heading must be provided using node extensions. PDF files are not allowed as leaf elements directly under 3.2.R Regional Information heading. Acceptable titles of the node extensions are: 3.2.R.1 Production Documentation;3.2.R.2 Medical Devices;3.2.R.3 Lot Release Documentation;3.2.R.4 Yearly Biologic Product Report;3.2.R.5 Assessment of Similarity;3.2.R.6 On Site Evaluation;3.2.R.7 Other Regional Information;3.2.R.8 Product Lifecycle Management Information;Warning will be reported if the naming of the title is not followed. Notes: The requirements above apply only to leaves provided using operation attribute "New". They don't apply to leaves provided using operation attribute "Replace". The exact naming convention of the titles of node extensions must be used when the node extension(s) is (are) created for the first time under this heading. If new or replaced leaves are provided when there are already existing node extensions in the 3.2.R Regional information heading, the leaves must be provided under the existing node extensions, even if they don't follow the exact naming convention of the node extension title. Warning generated during the validation can be ignored.

6.17.347

Verifies that the href target exists and has the correct value.

6.17.139

Verifies that the href target exists and matches the title value.

6.17.187

Reports any used content-block element.

6.17.106

Verifies that href values do not contain backslashes.

6.17.186

The value of the study-identifier/category element must not be empty.

6.17.185

The value of the study-identifier/study-id element must not be empty.

6.17.132

The value of the study-identifier/title element must not be empty.

6.17.130

Checks file tag values and category values against definitions in valid-values.xml file. Accepting values as defined in valid-values.xml v6.

6.17.184

STF leaf element must reference other STF leaf upon append. Such leaf elements must not reference PDF files as modified files.

6.17.183

Category information must be provided for certain STFs.

6.17.182

Leaf references in STFs must always target content files, not STFs.

6.17.141

STF files must reference at least one leaf.

6.17.140

The STF study IDs must not change in the application life cycle.

6.17.138

STFs should only be associated with certain headings under Modules 4 or 5.

6.17.135

There should be one and only one file tag for each doc-content.

6.17.134

If Study Tagging Files are used in the current sequence being validated, the node 5.3.7 must not be used. The Case Report Forms must be referenced from the Study Tagging Files. The previous sequences in the same dossier will not be checked.

6.17.284

Leaf elements in module 4 (except those in subsection 4.3), with an operation attribute "new", can use either node extensions, STFs or may be placed directly under the TOC sections. Leaf elements in subsections 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, and 5.3.7, with an operation attribute "new", can use only node extensions or STFs. Although both node extensions and STFs are acceptable for study reports, only one or the other approach should be used consistently throughout the lifecycle of a leaf. Also, in a specific sequence all leaf elements should use the same approach. Note: Previous sequences in the same dossier will not be checked, and neither will leaf elements with operation attributes other than "new".

6.17.285

Verifies the DTD version in the STF XML file.

6.17.143

An XML file will be reported as corrupt if the file cannot be opened because the file is damaged.

6.17.336

Checks the 1.2.1 Application Forms node. Generates error if the RT file is missing from the current eCTD sequence and was provided in the previous eCTD sequence. Note: This rule is not based on the presence of the RT file in the current sequence. This rule is based on the existence of the RT XML file or MF XML in the previous eCTD sequence. Error must not be generated if there is no RT xml or MF XML file present in the previous eCTD sequence.

6.17.337

Verifies the placement of the RT, PI or MF xml files. Generates error if they are placed in a node other than 1.2.1 Application Forms.

6.17.338

Checks the 1.2.1 Application Forms node. Generates error if, in addition to the RT xml file, there is a 3011 form named hc-sc-3011-en.pdf or hc-sc-3011-fr.pdf.

6.17.339

Checks the 1.2.1 Application Forms node. Generates error if in addition to the RT xml and PI xml or MF XML file there are other xml files. Error will also be reported if more than one RT or MF XML file is found in this node.

6.17.340

Compares the value in the Dossier ID field in the RT or MF xml file with the top level folder.

6.17.341

The operation attribute value in the leaf element must be “new” when provided for the first time, and “replace” when provided in subsequent transaction.

6.17.344

Checks the Dossier ID field in the RT or MF XML file. It must be lower case letter “e” followed by 6 digits.

6.17.346

Element values for “product_name” and “company_id” must not be empty.

6.17.345

Checks the software_version element value of the Regulatory Transaction (RT) and Master File (MF) XML files. For the latest versions of the RT and MF XML files accepted by Health Canada refer to: REP Summary Table - for Human Use Drugs (pharmaceutical, biologic and radiopharmaceutical), disinfectants, veterinary drugs and medical devices;Filling submissions electronically - for master files

6.17.463

XML files must be well formed and valid against the schema.

6.17.464

Referenced image files must be JPEG with the.jpeg extension.

6.17.465

All referenced image files must exist in the same folder as the XML file.

6.17.466

XML files must be named with the (Globally Unique Identifiers) GUID from the <document> <ID> root attribute.

6.17.467

Values for <setID> root attribute and <id> root attribute must not be empty, be unique and be a GUID. GUIDs must follow the canonical structure, content and formatting rules: displayed in five groups separated by hyphens, in the form 8-4-4-4-12 for a total of 36 characters (32 alphanumeric characters and four hyphens) and permitted characters only include a-f,0-9,- Note: Rule does not apply to <representedOrganization> root attribute and 'assignedOrganization' root attribute.

6.17.468

Date values associated with <effectiveTime> must be provided in the format YYYYMMDD.

6.17.469

Coded values and display names must be equal to the associated CV.

6.17.470

Coded values must include a valid codeSystem attribute or root attribute and must be present only in allowable context as outlined in Appendix 1 - Valid codeSystem attributes or root attribute in allowable contexts.

6.17.471

Coded value terms used should have Status = "Active" from the CV system. Other status values will lead to Warnings or Errors. The overall rule severity will be the highest severity of the non-Active values based on the "Controlled vocabulary" table.

6.17.472

displayName attributes must be equal to the language-specific CV display name. This does not apply to: <representedOrganization> <Id> root attribute 2.16.840.1.113883.2.20.6.31.;<assignedOrganization> <Id> root attribute 2.16.840.1.113883.2.20.6.31.

6.17.473

<id> extension attributes must not contain spaces.

6.17.474

<text>, <title>, <caption> and <content> must not be empty between opening and closing tags.

6.17.475

<characteristics> must not have a classCode attribute.

6.17.476

Major section headings listed below must not be immediately followed by <text> or <paragraph>: Code = "0TP" (TITLE PAGE);Code = "pi00" (PART I: HEALTH PROFESSIONAL INFORMATION);Code = "pii00" (PART II: SCIENTIFIC INFORMATION);Code = "pim00" (PATIENT MEDICATION INFORMATION)

6.17.477

The following elements and attributes must not be used: <performance>;<actDefinition>;<product>;<manufacturedMaterialKind>;<confidentialityCode>

6.17.478

No comments (i.e. "") are allowed.

6.17.479

<?xml> version attribute must be equal to "1.0". The encoding attribute must equal "UTF-8".

6.17.480

<?xml-stylesheet> href attribute must be equal to "https://health-products.canada.ca/product-monograph/style-sheet/v_#_#/spl_canada.xsl".

6.17.481

Only <?xml> and <?xml-stylesheet> XML declarations are allowed.

6.17.482

Values for style sheet version "v_#_#" must be taken from CV codeSystem 2.16.840.1.113883.2.20.6.65 and must be equal to a CV Code. The overall rule severity will be the highest severity of the non-Active values based on the "Style sheet version" table.

6.17.483

<document> xmlns attribute must be equal to "urn:hl7-org:v3". <document> xsi:schemaLocation attribute must be equal to "https://health-products.canada.ca/product-monograph/schema/SPL.xsd".

6.17.484

<document> <id> root attribute must not be empty, be unique and be a GUID.

6.17.485

Values for <document> <code> must be taken from CV codeSystem 2.16.840.1.113883.2.20.6.10. Specifically: The code attribute value must be equal to a CV Code. The displayName attribute must be equal to the language-specific CV display name for that Code.

6.17.486

Values for <languageCode> must be taken from CV codeSystem 2.16.840.1.113883.2.20.6.29. Specifically: The code attribute value must be equal to a CV Code. The displayName attribute must be equal to the language-specific CV display name for that Code.

6.17.487

<setId> root attribute must not be empty, be unique and be a GUID.

6.17.488

<versionNumber> value attribute must be an integer greater than zero.

6.17.489

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 'Fast Web Access' is enabled for all PDF files in the submission

6.17.16

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

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 Sequence Number contains four digits (i.e. numbers between 0000 to 9999) in the regional xml file and in the sequence folder

6.17.30

Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version

6.17.41

Ensure that the names of all files and folders in the submission corresponds to the ICH and/or regional agency defined folder structure and file names (i.e. extra subfolders should be reported, 'rp' or 'ap' suffix in file names of the ASMF submission shall be ignored by the validation)

6.17.49

Ensure that the reference to the stylesheet in the backbone xml files are directed to the stylesheet provided in the util folder

6.17.51

Ensure that the reference to the DTD or schema in the backbone xml files are directed to the DTD or schema provided in the util folder

6.17.52

Ensure that index MD5 txt file is named correctly (i.e. index-md5.txt)

6.17.54

Ensure that a valid ICH, regional and STF stylesheet exists in the util folder (i.e. checksum of the ICH and regional stylesheets in util folder must match the published checksum of the stylesheet provided by the agency) of the compiled and/or imported submission

6.17.55

Ensure that ICH and regional xml backbone files are named correctly

6.17.56

Ensure that all required ICH and regional DTD (including .mod files) and/or Schema files referenced in the submission must exists in correct location (i.e. <app-id>\<seq-num>\util\dtd) and these files are named correctly

6.17.57

Ensure that ICH and regional stylesheet files exist in correct location (i.e. <app-id>\<seq-num>\util\style) and are named correctly

6.17.58

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

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

Provide list of all documents in the submission containing annotation (other than links and bookmarks)

6.17.81

Provide list of all documents in the submission containing annotation (other than links and bookmarks)

6.17.83

Ensure that the link and/or bookmark destination does not point to a corrupt document

6.17.91

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 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 files in study sections are referenced by an STF

6.17.142

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 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

Report following information about the STFs in the submission (number and total size of non E3 documents). [Non E3 study files] Total size (KB): -- ;Number of 16.3 files: -- (value is determined by keeping count of ICH file tags in STF); Number of US files: -- (value is determined by keeping count of US file tags in STF);Number of JP files: -- (value is determined by keeping count of JP file tags in STF)

6.17.216

Ensure that there is a stylesheet declaration in backbone xml files (index, regional and STF)

6.17.229

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