﻿<?xml version="1.0" encoding="utf-8"?>
<?xml-stylesheet type="text/xsl" href="util/validationreport.xsl"?>
<validationreport>
	<summaries>
		<summary id="application-name" description="Application Name"></summary>
		<summary id="location" description="Location"></summary>
		<summary id="sequence-number" description="Sequence Number"></summary>
		<summary id="regional-backbone-version" description="Region/DTD"></summary>
		<summary id="validation-profile" description="Validation Profile"></summary>
		<summary id="selected-modules" description="Selected Modules"></summary>
		<summary id="result" description="Result"></summary>
	</summaries>
	<validations id="0" description="TH Criteria">
		<validation id="1" description="1 - ICH DTD">
			<validation id="1.1" description="The specified filename is used" severity="Error">
				<validator type="log" dependingOption="th-10-1">RegionalDtdExists</validator>
				<validator type="log" dependingOption="th-10-1">RegionalModFileExist</validator>
				<validator type="log" dependingOption="th-10-1">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="th-10-1">IchDtdExists</validator>
			</validation>
			<validation id="1.2" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-1">RegionalDtdExists</validator>
				<validator type="log" dependingOption="th-10-1">RegionalModFileExist</validator>
				<validator type="log" dependingOption="th-10-1">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="th-10-1">IchDtdExists</validator>
			</validation>
			<validation id="1.3" description="A currently acceptable version of the DTD is used (checksum matches the published value)" severity="Error">
				<validator type="log" dependingOption="th-10-1">IchChecksumFailed</validator>
			</validation>
			<validation id="1.4" description="The version number of the DTD/specification used in the sequence being tested is higher than or equal to the version of the DTD used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="th-10-1">IchDtdVersionPreceding</validator>
			</validation>
			<validation id="1.5" description="The version number of the DTD/specification used in the sequence being tested is lower than or equal to the version of the DTD used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="th-10-1">IchDtdVersionSucceeding</validator>
			</validation>
		</validation>
		<validation id="2" description="2 - ICH Style-Sheet">
			<validation id="2.1" description="The specified filename is used" severity="Error">
				<validator type="log" dependingOption="th-10-2">StyleSheetExist</validator>
			</validation>
			<validation id="2.2" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-2">StyleSheetExist</validator>
			</validation>
			<validation id="2.3" description="The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence" severity="Error">
				<validator type="log" dependingOption="th-10-2">StyleSheetChecksumFailed</validator>
			</validation>
		</validation>
		<validation id="3" description="3 - TH M1 Schema">
			<validation id="3.1" description="The specified filename is used" severity="Error">
				<validator type="log" dependingOption="th-10-3">RegionalDtdExists</validator>
				<validator type="log" dependingOption="th-10-3">RegionalModFileExist</validator>
				<validator type="log" dependingOption="th-10-3">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="th-10-3">IchDtdExists</validator>
			</validation>
			<validation id="3.2" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-3">RegionalDtdExists</validator>
				<validator type="log" dependingOption="th-10-3">RegionalModFileExist</validator>
				<validator type="log" dependingOption="th-10-3">UtilFilesInvalidPath</validator>
				<validator type="log" dependingOption="th-10-3">IchDtdExists</validator>
			</validation>
			<validation id="3.3" description="A currently acceptable version of the Schema is used (checksum matches the published value)" severity="Error">
				<validator type="log" dependingOption="th-10-3">DtdChecksumFailed</validator>
			</validation>
			<validation id="3.4" description="The version number of the Schema/specification used in the sequence being tested is higher than or equal to the version of the Schema used in the sequence numerically preceding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="th-10-3">RegionalDtdVersionPreceding</validator>
			</validation>
			<validation id="3.5" description="The version number of the Schema/specification used in the sequence being tested is lower than or equal to the version of the Schema used in the sequence numerically succeeding the incoming sequence in the eCTD lifecycle." severity="Error">
				<validator type="log" dependingOption="th-10-3">RegionalDtdVersionSucceeding</validator>
			</validation>
		</validation>
		<validation id="4" description="4 - EU M1 Leaf MOD File">
			<validation id="" description="VALIDATION SECTION NOT APPLICABLE FOR THAILAND" severity="">
			</validation>
		</validation>
		<validation id="5" description="5 - EU M1 Envelope MOD File">
			<validation id="" description="VALIDATION SECTION NOT APPLICABLE FOR THAILAND" severity="">
			</validation>
		</validation>
		<validation id="6" description="6 - TH M1 Style-sheet">
			<validation id="6.1" description="The specified filename is used" severity="Error">
				<validator type="log" dependingOption="th-10-8">StyleSheetExist</validator>
			</validation>
			<validation id="6.2" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-8">StyleSheetExist</validator>
			</validation>
			<validation id="6.3" description="The checksum for the stylesheet used must match the published checksum for the stylesheet associated with the DTD used for the sequence" severity="Error">
				<validator type="log" dependingOption="th-10-8">StyleSheetChecksumFailed</validator>
			</validation>
		</validation>
		<validation id="7" description="7 - Index XML">
			<validation id="7.1" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-9">SchemaVersion</validator>
				<validator type="log" dependingOption="th-10-9">Backbone.NotExist</validator>
				<validator type="log" dependingOption="th-10-9">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="7.2" description="The file is named correctly" severity="Error">
				<validator type="log" dependingOption="th-10-9">SchemaVersion</validator>
				<validator type="log" dependingOption="th-10-9">EU_CH_GC_AUBackbone.NotExist</validator>
			</validation>
			<validation id="7.3" description="The file is well formed" severity="Error">
				<validator type="log" dependingOption="th-10-9">Xml</validator>
			</validation>
			<validation id="7.4" description="The file is valid" severity="Error">
				<validator type="log" dependingOption="th-10-9">Xml</validator>
			</validation>
			<validation id="7.5" description="The reference to the DTD in index.xml is directed to the DTD provided in the util folder." severity="Error">
				<validator type="log" dependingOption="th-10-9">Util.NotExisted</validator>
				<validator type="log" dependingOption="th-10-9">InvalidSchemaOrDtdLocation</validator>
			</validation>
			<validation id="7.6" description="The reference to the stylesheet in index.xml is directed to the stylesheet provided in the util folder." severity="Error">
				<validator type="log" dependingOption="th-10-9">InvalidStyleSheetLocation</validator>
			</validation>
		</validation>
		<validation id="8" description="8 - Index MD5 txt">
			<validation id="8.1" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-10">SubmissionChecksumFileName.Failed</validator>
				<validator type="log" dependingOption="th-10-10">SubmissionChecksum.Failed</validator>
			</validation>
			<validation id="8.2" description="The file is named correctly" severity="Error">
				<validator type="log" dependingOption="th-10-10">SubmissionChecksumFileName.Failed</validator>
				<validator type="log" dependingOption="th-10-10">SubmissionChecksum.Failed</validator>
			</validation>
			<validation id="8.3" description="The regenerated checksum for the index.xml matches the value in the file index-md5.txt." severity="Error">
				<validator type="log" dependingOption="th-10-10">Index.Checksum.Failed</validator>
			</validation>
		</validation>
		<validation id="9" description="9 - TH Regional XML">
			<validation id="9.1" description="The file is placed in the correct folder" severity="Error">
				<validator type="log" dependingOption="th-10-11">SchemaVersion</validator>
				<validator type="log" dependingOption="th-10-11">Backbone.NotExist</validator>
				<validator type="log" dependingOption="th-10-11">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="9.2" description="The file is named correctly" severity="Error">
				<validator type="log" dependingOption="th-10-11">SchemaVersion</validator>
				<validator type="log" dependingOption="th-10-11">EU_CH_GC_AUBackbone.NotExist</validator>
			</validation>
			<validation id="9.3" description="The file is well formed" severity="Error">
				<validator type="log" dependingOption="th-10-11">Xml</validator>
			</validation>
			<validation id="9.4" description="The file is valid" severity="Error">
				<validator type="log" dependingOption="th-10-11">Xml</validator>
			</validation>
			<validation id="9.5" description="The reference to the Schema in th-regional.xml is directed to the Schema provided in the util folder." severity="Error">
				<validator type="log" dependingOption="th-10-11">Util.NotExisted</validator>
				<validator type="log" dependingOption="th-10-11">InvalidSchemaOrDtdLocation</validator>
			</validation>
			<validation id="9.6" description="The reference to the stylesheet in th-regional.xml is directed to the stylesheet provided in the util folder." severity="Error">
				<validator type="log" dependingOption="th-10-11">InvalidStyleSheetLocation</validator>
			</validation>
		</validation>
		<validation id="10" description="10 - Submission Structure">
			<validation id="10.1" description="All the lowest level heading elements in the XML (including node-extensions) included in the submission contain at least one leaf" severity="Error">
				<validator type="log" dependingOption="th-10-12">FolderEmpty</validator>
				<validator type="log" dependingOption="th-10-12">ValidationFailed</validator>
			</validation>
		</validation>
		<validation id="11" description="11 - Leaf Attributes">
			<validation id="11.1" description="The leaf attribute &quot;checksum-type&quot; has a value of md5 or MD5" severity="Error">
				<validator type="log" dependingOption="th-10-13">ChecksumType.Incorrect</validator>
			</validation>
			<validation id="11.2" description="The regenerated checksum for each file matches the value in the leaf attribute &quot;checksum&quot;" severity="Error">
				<validator type="log" dependingOption="th-10-13">Checksum.Failed</validator>
			</validation>
			<validation id="11.3" description="For every leaf the &quot;title&quot; attribute is not empty" severity="Error">
				<validator type="log" dependingOption="th-10-13">NodeExtension.Title.Empty</validator>
				<validator type="log" dependingOption="th-10-13">Leaf.Title.Empty</validator>
			</validation>
			<validation id="11.4" description="All leaves with an operation attribute value of new, replace or append must have a value for the cross reference (xlink:href)" severity="Error">
				<validator type="log" dependingOption="th-10-13">BlankHref</validator>
			</validation>
			<validation id="11.5" description="All leaves with an operation attribute value of delete must have no value for the cross reference (xlink:href)" severity="Error">
				<validator type="log" dependingOption="th-10-13">DeletedLeaf.Href.NotBlank</validator>
			</validation>
			<validation id="11.6" description="The file referenced by the cross reference (xlink:href) must exist in the same or a previously submitted sequence within the same eCTD application" severity="Error">
				<validator type="log" dependingOption="th-10-13">HrefPointToFile.NotExist</validator>
			</validation>
			<validation id="11.7" description="All leaves with an operation attribute value of replace, delete or append must have a value for modified-file" severity="Error">
				<validator type="log" dependingOption="th-10-13">LeafTitle.Required</validator>
				<validator type="log" dependingOption="th-10-13">ModifiedFile.Unverifiable</validator>
			</validation>
			<validation id="11.8" description="All leaves with an operation attribute value of new must have no value for modified-file" severity="Error">
				<validator type="log" dependingOption="th-10-13">ModifiedFileExist</validator>
			</validation>
			<validation id="11.9" description="The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application" severity="Error">
				<validator type="log" dependingOption="th-10-13">ModifiedFileNotFound</validator>
				<validator type="log" dependingOption="th-10-13">HrefEmpty</validator>
			</validation>
			<validation id="11.10" description="For all leaves with an operation attribute value of replace, delete or append, the modified file must be present in the same CTD section of the dossier. Using the operation attribute 'delete' to remove content in sections in EU m1 which are no longer used, due to updates of the CTD, should be exempt from this rule." severity="Error">
				<validator type="log" dependingOption="th-10-13">ModifiedFile.NotInSameSection</validator>
			</validation>
		</validation>
		<validation id="12" description="12 - Node Extensions">
			<validation id="12.1" description="For every node-extension the &quot;title&quot; attribute is not empty" severity="Error">
				<validator type="log" dependingOption="th-10-14">NodeExtension.Title.Empty</validator>
				<validator type="log" dependingOption="th-10-14">Leaf.Title.Empty</validator>
			</validation>
		</validation>
		<validation id="13" description="13 - Sequence Number">
			<validation id="13.1" description="The sequence folder name is a 4 digit number" severity="Error">
				<validator type="log" dependingOption="th-10-15">SequenceNumberCharacters</validator>
			</validation>
			<validation id="13.2" description="The sequence number (folder name) has not already been used" severity="Error">
				<validator type="log" dependingOption="th-10-15">SameSequenceNumber</validator>
			</validation>
			<validation id="13.3" description="The sequence folder name matches the sequence number in each envelope in th-regional.xml" severity="Error">
				<validator type="log" dependingOption="th-10-15">SequenceNumberNotMatch</validator>
				<validator type="log" dependingOption="th-10-15">SequenceNumberNumeric</validator>
			</validation>
		</validation>
		<validation id="14" description="14 - Envelope Attributes">
			<validation id="14" description="The related-sequence attribute must have one value and contain 4 numeric digits only." severity="Error">
				<validator type="log" dependingOption="th-10-16">InvalidRelatedSequence</validator>
			</validation>
		</validation>
		<validation id="15" description="15 - Files/Folders">
			<validation id="15.1" description="The files provided in the folders for Module 1 are in acceptable formats" severity="Error">
				<validator type="log" dependingOption="th-10-17">FileType.Invalid</validator>
			</validation>
			<validation id="15.2" description="The files provided in the folders for Module 2-5 are in acceptable formats" severity="Error">
				<validator type="log" dependingOption="th-10-17">FileType.Invalid</validator>
			</validation>
			<validation id="15.3" description="Total file folder path length must not exceed 180 characters" severity="Error">
				<validator type="log" dependingOption="th-10-17">LongPath</validator>
			</validation>
			<validation id="15.4" description="File names, including the extension, must not exceed 64 characters" severity="Error">
				<validator type="log" dependingOption="th-10-17">CA.LongFileName</validator>
				<validator type="log" dependingOption="th-10-17">LongFileName</validator>
			</validation>
			<validation id="15.5" description="Folder names must not exceed 64 characters" severity="Error">
				<validator type="log" dependingOption="th-10-17">CA.LongFileName</validator>
				<validator type="log" dependingOption="th-10-17">LongFileName</validator>
			</validation>
			<validation id="15.6" description="Only valid characters are used in file names" severity="Error">
				<validator type="log" dependingOption="th-10-17">Path.Invalid</validator>
			</validation>
			<validation id="15.7" description="Only valid characters are used in folder names" severity="Error">
				<validator type="log" dependingOption="th-10-17">Path.Invalid</validator>
			</validation>
			<validation id="15.8" description="There are no unreferenced files in M1, M2, M3, M4 and M5 folders" severity="Error">
				<validator type="log" dependingOption="th-10-17">File.Extra</validator>
				<validator type="log" dependingOption="th-10-17">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="th-10-17">M1Folder.RedundantFiles</validator>
			</validation>
			<validation id="15.9" description="The only files in the sequence folder (/XXXX/…) are the index.xml and index-md5.txt" severity="Error">
				<validator type="log" dependingOption="th-10-17">File.Extra</validator>
				<validator type="log" dependingOption="th-10-17">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="th-10-17">M1Folder.RedundantFiles</validator>
			</validation>
			<validation id="15.10" description="There are no empty folders" severity="Error">
				<validator type="log" dependingOption="th-10-17">EmptyFolder</validator>
			</validation>
			<validation id="15.11" description="The tracking table file is present in the correct location" severity="Error">
				<validator type="log" dependingOption="th-10-17">TrackingTableFileTH10</validator>
			</validation>
			<validation id="15.12" description="The tracking table file is correctly named" severity="Error">
				<validator type="log" dependingOption="th-10-17">TrackingTableFile</validator>
			</validation>
			<validation id="15.BP1" description="Individual files do not exceed 100 MB in size" severity="Warning">
				<validator type="log" dependingOption="th-10-17">File.Size</validator>
			</validation>
			<validation id="15.BP2" description="The recommended folder structure and folder names in the ICH and TH specifications are used" severity="Information">
				<validator type="log" dependingOption="th-10-17">NamingConvention.Inconsistent</validator>
				<validator type="log" dependingOption="th-10-17">M1.NamingConvention.NotMatch</validator>
			</validation>
			<validation id="15.BP3" description="The recommended file names from the ICH and TH specifications are used for all files" severity="Information">
				<validator type="log" dependingOption="th-10-17">NamingConvention.Inconsistent</validator>
				<validator type="log" dependingOption="th-10-17">M1.NamingConvention.NotMatch</validator>
			</validation>
		</validation>
		<validation id="16" description="16 - PDF Files">
			<validation id="16.1" description="No PDF has been created and saved as version 1.3 or earlier" severity="Error">
				<validator type="log" dependingOption="th-10-18">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="16.2" description="There is no security setting to open any individual file" severity="Error">
				<validator type="log" dependingOption="th-10-18">PdfSecurity</validator>
			</validation>
			<validation id="16.3" description="There are no further security settings applied to any individual file (except for files in Modules 1.2, 3.3, 4.3 and 5.4)" severity="Error">
				<validator type="log" dependingOption="th-10-18">PdfSecurity</validator>
			</validation>
			<validation id="16.4" description="Individual files in section 1.2 have no security settings except for the following, which are allowed:Changing the documentDocument assemblyPage extractionCreation of template pages." severity="Error">
				<validator type="log" dependingOption="th-10-18">DeniedPermission</validator>
			</validation>
			<validation id="16.5" description="The submission does not contain corrupted files" severity="Error">
				<validator type="log" dependingOption="th-10-18">Pdf.Failed</validator>
			</validation>
			<validation id="16.BP1" description="Files have been created and saved as PDF 1.4, 1.5, 1.6, or PDF 1.7" severity="Warning">
				<validator type="log" dependingOption="th-10-18">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="16.BP2" description="Hyperlinks and bookmarks within documents, or between documents within the same sequence, have a valid target." severity="Warning">
				<validator type="log" dependingOption="th-10-18">BrokenLinkInPdf</validator>
				<validator type="log" dependingOption="th-10-18">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="16.BP3" description="Hyperlinks and bookmarks to destinations in a different sequence in the same eCTD have a valid target." severity="Warning">
				<validator type="log" dependingOption="th-10-18">BrokenLinkInPdf</validator>
				<validator type="log" dependingOption="th-10-18">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="16.BP4" description="All hyperlinks and bookmarks are set to &quot;inherit zoom&quot;" severity="Warning">
				<validator type="log" dependingOption="th-10-18">Pdf.InvalidMagnification</validator>
				<validator type="log" dependingOption="th-10-18">Bookmark.Pdf.InvalidMagnification</validator>
			</validation>
			<validation id="16.BP5" description="PDFs must have &quot;Fast Web View&quot; active" severity="Warning">
				<validator type="log" dependingOption="th-10-18">PdfFastWebAccess</validator>
			</validation>
			<validation id="16.BP6" description="PDF Document Properties for the Initial View are set for &quot;Page Layout = Default&quot; and &quot;Magnification = Default&quot;" severity="Warning">
				<validator type="log" dependingOption="th-10-18">Pdf.InvalidInitialView</validator>
			</validation>
			<validation id="16.BP7" description="All PDF hyperlinks and bookmarks are relative" severity="Warning">
				<validator type="log" dependingOption="th-10-18">AbsolutePathInPdf</validator>
				<validator type="log" dependingOption="th-10-18">AbsolutePathBookmarkInPdf</validator>
			</validation>
			<validation id="16.BP8" description="The bookmarks pane should be visible if bookmarks are included within a PDF document" severity="Warning">
				<validator type="log" dependingOption="th-10-18">Pdf.InvalidInitialView.Bookmark</validator>
			</validation>
			<validation id="16.BP9" description="The bookmarks pane should not be visible if there are no bookmarks included within a PDF document" severity="Warning">
				<validator type="log" dependingOption="th-10-18">InvalidPageModeWhenNoBookmark</validator>
			</validation>
			<validation id="16.BP10" description="All hyperlinks and bookmarks between two PDFs must be configured as specified in ISO 32000-1:2008" severity="Warning">
				<validator type="log" dependingOption="th-10-18">PdfBackslash</validator>
				<validator type="log" dependingOption="th-10-18">PdfBackslashBookmark</validator>
			</validation>
		</validation>
		<validation id="17" description="17 - Study Tagging Files (STFs)">
			<validation id="17.1" description="Check Index Reference" severity="Error">
				<validator type="log" dependingOption="th-10-19">Stf.LeafId.NotExist</validator>
			</validation>
			<validation id="17.2" description="Check Index Reference (title match)" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.DocContent.Title.NotMatch</validator>
			</validation>
			<validation id="17.3" description="Content Block are not accepted" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.ContentBlock.NotAccepted</validator>
			</validation>
			<validation id="17.4" description="No backslash in xlink:href reference" severity="Error">
				<validator type="log" dependingOption="th-10-19">StfHrefHasBackslashes</validator>
			</validation>
			<validation id="17.5" description="Study Identifier category must not be empty" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.Categories.Empty</validator>
			</validation>
			<validation id="17.6" description="Study Identifier study-id must not be empty" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.StudyId.Empty</validator>
				<validator type="log" dependingOption="th-10-19">Stf.NotExist</validator>
			</validation>
			<validation id="17.7" description="Study Identifier title must not be empty" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.Title.Empty</validator>
			</validation>
			<validation id="17.8" description="Categories and file tags" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.FileTag.NotSupported</validator>
				<validator type="log" dependingOption="th-10-19">Stf.Category.NotSupported</validator>
			</validation>
			<validation id="17.9" description="STF leaf elements must reference other STF leaf upon append" severity="Error">
				<validator type="log" dependingOption="th-10-19">Stf.Append.ReferenceOtherStf</validator>
			</validation>
			<validation id="17.10" description="Category information must be provided for certain STFs" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.Category.Missing</validator>
			</validation>
			<validation id="17.11" description="STF cannot reference another STF" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.ReferenceStf</validator>
			</validation>
			<validation id="17.12" description="STF files must reference at least one leaf" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.NotHasReferencedLeaf</validator>
			</validation>
			<validation id="17.13" description="Study ID for STF must remain constant" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.StudyId.NotMatch</validator>
			</validation>
			<validation id="17.14" description="Invalid STF TOC location" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.WrongSection</validator>
			</validation>
			<validation id="17.15" description="STF doc-content file tag count" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.FileTag.NotExist1</validator>
			</validation>
			<validation id="17.16" description="STF XML title and leaf element title do not match" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.Title.NotMatch</validator>
			</validation>
			<validation id="17.17" description="Detect invalid life cycle pattern: Append operations not appending to most recent STF leaf" severity="Warning">
				<validator type="log" dependingOption="th-10-19">Stf.AppendOperation</validator>
			</validation>
			<validation id="STF_INFO" description="Informational output about the number and total size of non E3 documents." severity="Information">
				<validator type="log" dependingOption="th-10-19">Stf.E3Info</validator>
			</validation>
		</validation>
		<validation id="18" description="Recommended">
			<validation id="Recommended" description="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'" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Checksum.IsNotPresent</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'checksum' attribute value is not provided when 'operation' attribute for the leaf(s) is 'delete'" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Checksum.IsPresent</validator>
			</validation>
			<validation id="Recommended" description="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)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Index.Checksum.InvalidFormat</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the checksum of the DTD for STFs provided in the util folder must match the checksum value provided by the agency" severity="Warning">
				<validator type="log" dependingOption="th-10-20">StfChecksumFailed</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all files must have one and only one file extension" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InconsistentExtensions</validator>
			</validation>
			<validation id="Recommended" description="Ensure that value for ID attribute must start with a letter or underscore character" severity="Warning">
				<validator type="log" dependingOption="th-10-20">LeafId.Invalid</validator>
			</validation>
			<validation id="Recommended" description="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" severity="Warning">
				<validator type="log" dependingOption="th-10-20">SpecialFile.Size</validator>
			</validation>
			<validation id="Recommended" description="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)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">References.AcrossApplication</validator>
			</validation>
			<validation id="Recommended" description="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'&lt;', greater than'&gt;', pipe'|', or space ' ', file path relative to the backbone xml files and includes file name in the path)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Attribute.InvalidCharacters</validator>
				<validator type="log" dependingOption="th-10-20">HrefRelativePath</validator>
				<validator type="log" dependingOption="th-10-20">ModifiedFileRelativePath</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'util' folder exists and is in the correct location (&lt;sequence number&gt;/util)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Util.NotExisted</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the syntax of the modified-file attribute is in accordance with the ICH 3.2 DTD version" severity="Warning">
				<validator type="log" dependingOption="th-10-20">ModifiedFile.IncorrectSyntax</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all files and folders in the submission are accessible to the user" severity="Warning">
				<validator type="log" dependingOption="th-10-20">AccessibleFileFolder</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the hyperlinks and/or bookmarks in the submission documents does not target document outside current eCTD application" severity="Warning">
				<validator type="log" dependingOption="th-10-20">RefOutsideSeqOrApp</validator>
				<validator type="log" dependingOption="th-10-20">RefOutsideSeqOrAppBookmark</validator>
			</validation>
			<validation id="Recommended" description="Provide list of all documents in the submission containing annotation (other than links and bookmarks)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">PdfAnnotations</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all pdf documents in the submission must not have any attachments" severity="Warning">
				<validator type="log" dependingOption="th-10-20">PdfAttachmentDetected</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not have multiple actions (e.g. opening two different pages)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">PdfMultipleAction</validator>
				<validator type="log" dependingOption="th-10-20">PdfMultipleActionBookmark</validator>
			</validation>
			<validation id="Recommended" description="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)." severity="Warning">
				<validator type="log" dependingOption="th-10-20">PdfInactiveBookmarkHyperlink</validator>
				<validator type="log" dependingOption="th-10-20">PdfInactiveBookmark</validator>
			</validation>
			<validation id="Recommended" description="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" severity="Warning">
				<validator type="log" dependingOption="th-10-20">PdfUnknownAction</validator>
				<validator type="log" dependingOption="th-10-20">PdfUnknownActionBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not point to external destinations (other than web or email)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">PdfExternalDestinationHyperLink</validator>
				<validator type="log" dependingOption="th-10-20">PdfExternalDestinationBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all hyperlinks and bookmarks in the submission documents must not point to web address or email" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Pdf.UseURLLink</validator>
				<validator type="log" dependingOption="th-10-20">ExternalBookmark</validator>
			</validation>
			<validation id="Recommended" description="Print the count of all of the hyperlinks and the bookmarks with following criteria:&#xA;- Non-Relative Hyperlinks&#xA;- Non-Relative Bookmarks&#xA;- Web link and email hyperlinks&#xA;- Web links and email bookmarks&#xA;- External Hyperlinks (excluding web links and emails)&#xA;- External Bookmarks (excluding web links and emails)&#xA;- Unknown Action Hyperlinks&#xA;- Unknown Action Bookmarks&#xA;- Inactive Hyperlinks&#xA;- Inactive Bookmarks&#xA;- Broken Hyperlinks (separate count for inter-application, intra-application and intra-sequence)&#xA;- Broken Bookmarks (separate count for inter-application, intra-application and intra-sequence)&#xA;- Number of bookmarks per document&#xA;- Total number of bookmarks in the submission&#xA;- Number of hyperlinks per document&#xA;- Total number of hyperlinks in the submission" severity="Information">
				<validator type="log" dependingOption="th-10-20">PdfTotalNonRelativeBookmarks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalWebEmailDestinationBookmarks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalExternalDestinationBookmarks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalUnknownActionBookmarks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalInActiveBookmarks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalBrokenBookmarks</validator>
				<validator type="log" dependingOption="th-10-20">PdfNumberOfBookmarksPerDocument</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalBookmarksInSubmission</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalNonRelativeHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalWebEmailDestinationHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalExternalDestinationHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalUnknownActionHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalInActiveHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalBrokenHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalHyperLinks</validator>
				<validator type="log" dependingOption="th-10-20">PdfTotalHyperLinksInSubmission</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the link and/or bookmark destination does not point to a corrupt document" severity="Warning">
				<validator type="log" dependingOption="th-10-20">RefDocCorrupted</validator>
				<validator type="log" dependingOption="th-10-20">RefDocCorruptedBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the links and/or bookmark in the submission documents point to an existing page and/or named destinations" severity="Warning">
				<validator type="log" dependingOption="th-10-20">BlankLinkInPdf</validator>
				<validator type="log" dependingOption="th-10-20">BlankLinkInPdfBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'property' element (if present) is listed before its sibling 'file-tag' element in all of the stf files of the submission" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.PropertyBeforeFiletag</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'property' element is present in all of the stf files in the submission created with STF DTD v2.0 only" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.MissingProperty</validator>
			</validation>
			<validation id="Recommended" description="Ensure that child element 'title' is not provided in the doc-content of the STF files in the submission" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.TitleNotProvided</validator>
			</validation>
			<validation id="Recommended" description="Ensure that an STF xml file is referenced in a submission only once" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.ReferencedMultiple</validator>
			</validation>
			<validation id="Recommended" description="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)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF’s in the submission are named correctly based on the naming convention i.e. ‘STF-&lt;study-id&gt;.xml’" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InvalidStfFileName</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STFs in the submission have valid file extension (file extension is not missing and it is .xml)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InvalidStfFileName</validator>
			</validation>
			<validation id="Recommended" description="Ensure that files in study sections are referenced by an STF" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.NotReferencedInSTF</validator>
			</validation>
			<validation id="Recommended" description="Ensure that valid STF DTD version (e.g. dtd-version = &quot;2.2&quot;) is referenced in the STF XML file" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.UnsupportedSchemaVersion</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'title' element of the 'leaf' and/or 'node-extension' does not begins or ends with a space" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Leaf.Title.LeadsOrEndsWithSpace</validator>
				<validator type="log" dependingOption="th-10-20">NodeExtension.Title.LeadsOrEndsWithSpace</validator>
			</validation>
			<validation id="Recommended" description="Ensure that valid/supported 'dtd-version' is referenced in the ICH and regional backbone xml files" severity="Warning">
				<validator type="log" dependingOption="th-10-20">DtdVersion.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'dtd-version' is referenced in the ICH and regional backbone xml files" severity="Warning">
				<validator type="log" dependingOption="th-10-20">IchDtdVersion</validator>
				<validator type="log" dependingOption="th-10-20">RegionalDtdVersion</validator>
			</validation>
			<validation id="Recommended" description="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)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">AttributeMissing</validator>
			</validation>
			<validation id="Recommended" description="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" severity="Warning">
				<validator type="log" dependingOption="th-10-20">SpaceInAttribute</validator>
			</validation>
			<validation id="Recommended" description="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)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">File.Extra.InUtil</validator>
			</validation>
			<validation id="Recommended" description="Ensure that operation attribute is present and valid value ('new', 'append', 'replace' or 'delete') for the attribute is provided" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InvalidLeafOperation</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'operation' attributes for cover letter and application form leaf must be 'new'" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Operation.InvalidNewOperation</validator>
			</validation>
			<validation id="Recommended" description="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.)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InvalidLifeCyclePatternAppendOnAppend</validator>
			</validation>
			<validation id="Recommended" description="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.)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InvalidLifeCycleOperation.MultipleDelete</validator>
			</validation>
			<validation id="Recommended" description="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.)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InvalidLifeCycleOperation.Append</validator>
				<validator type="log" dependingOption="th-10-20">InvalidLifeCycleOperation.Delete</validator>
				<validator type="log" dependingOption="th-10-20">InvalidLifeCycleOperation.Replace</validator>
			</validation>
			<validation id="Recommended" description="Ensure same xlink:href is not referenced more than once in the backbone xml files" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Href.Reused</validator>
			</validation>
			<validation id="Recommended" description="Ensure that all element in the submission backbone xml files must have leaf child nodes" severity="Warning">
				<validator type="log" dependingOption="th-10-20">NoneLeafElement</validator>
			</validation>
			<validation id="Recommended" description="Ensure that xlink:href attribute in backbone xml files does not point to leaf outside current sequence" severity="Information">
				<validator type="log" dependingOption="th-10-20">References.FilesOutsideSequence</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'xlink:href' attribute in backbone xml files does not point to leaf outside application." severity="Information">
				<validator type="log" dependingOption="th-10-20">References.FilesOutsideApplication</validator>
			</validation>
			<validation id="Recommended" description="Ensure that only operation 'new' is used for all leafs in the initial sequence of the application" severity="Warning">
				<validator type="log" dependingOption="th-10-20">OperationNew</validator>
			</validation>
			<validation id="Recommended" description="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.)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">MultipleOperationOnSingleLeaf</validator>
			</validation>
			<validation id="Recommended" description="Ensure attribute (if present i.e. indication, excipient, dosage-form, manufacturer, product-name, substance etc.) value must not be empty string" severity="Warning">
				<validator type="log" dependingOption="th-10-20">ICHMetadataAttribute.EmptyValue</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the initial sequence of the application must be '0000'" severity="Warning">
				<validator type="log" dependingOption="th-10-20">InitialSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Identify and report all invalid STF files. STF files with an incorrect name will be also reported" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.List</validator>
			</validation>
			<validation id="Recommended" description="Report following information about the STFs in the submission (number and total size of non E3 documents).&#xA;[Non E3 study files]&#xA;Total size (KB): -- &#xA;Number of 16.3 files: -- (value is determined by keeping count of ICH file tags in STF)&#xA;Number of US files: -- (value is determined by keeping count of US file tags in STF)&#xA;Number of JP files: -- (value is determined by keeping count of JP file tags in STF)" severity="Information">
				<validator type="log" dependingOption="th-10-20">Stf.E3Info</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the sequence being validated is the highest sequence in the application" severity="Warning">
				<validator type="log" dependingOption="th-10-20">CA.HighestSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the reference for the regional xml backbone file in index.xml must have operation attribute value 'new'" severity="Warning">
				<validator type="log" dependingOption="th-10-20">RegionalBackboneReferenced.WrongOperationAttribute</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'm1' folder must exist in the submission" severity="Warning">
				<validator type="log" dependingOption="th-10-20">M1Folder.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that there is a stylesheet declaration in backbone xml files (index, regional and STF)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Xml.StyleSheet</validator>
			</validation>
			<validation id="Recommended" description="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)" severity="Warning">
				<validator type="log" dependingOption="th-10-20">SequenceNumber.IncreasesIncrementally</validator>
			</validation>
			<validation id="Recommended" description="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" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.TrialSummary.Present</validator>
			</validation>
			<validation id="Recommended" description="Ensure that only one dataset of each type (filename configured) referenced in an STF is marked as 'new' operation&#xA;Note: This is applicable for :&#xA;Module 4 : section 4.2.3.1, 4.2.3.2, 4.2.3.4&#xA;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" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Stf.FileName.Specific</validator>
			</validation>
			<validation id="Recommended" description="Ensure PDF documents with more than 10 pages must have bookmarks" severity="Warning">
				<validator type="log" dependingOption="th-10-20">Pdf.Bookmark</validator>
			</validation>
		</validation>
	</validations>
</validationreport>