﻿<?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="CN Criteria">
		<validation id="1" description="1 - Basic Identification">
			<validation id="1.1" description="File Quantity Statistics" severity="Information">
				<validator type="log" dependingOption="cn-11-1">SubmissionFileStatistics</validator>
			</validation>
			<validation id="1.2" description="File Size Statistics" severity="Information">
				<validator type="log" dependingOption="cn-11-1">SubmissionFileStatistics</validator>
			</validation>
			<validation id="1.3" description="Empty Chapters Statistics" severity="Information">
				<validator type="log" dependingOption="cn-11-1">FolderEmpty</validator>
			</validation>
		</validation>
		<validation id="2" description="2 - File/ Folder">
			<validation id="2.1" description="The file folder must not be empty." severity="Error">
				<validator type="log" dependingOption="cn-11-2">EmptyFolder</validator>
			</validation>
			<validation id="2.2" description="The file size limit should not be exceeded." severity="Error">
				<validator type="log" dependingOption="cn-11-2">SpecialFile.Size</validator>
				<validator type="log" dependingOption="cn-11-2">File.Size</validator>
			</validation>
			<validation id="2.3" description="Unreferenced files are not allowed." severity="Error">
				<validator type="log" dependingOption="cn-11-2">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="cn-11-2">File.Extra</validator>
				<validator type="log" dependingOption="cn-11-2">M1Folder.RedundantFiles</validator>
			</validation>
			<validation id="2.4" description="File type (file extension check)" severity="Error">
				<validator type="log" dependingOption="cn-11-2">InconsistentExtensions</validator>
				<validator type="log" dependingOption="cn-11-2">FileTypeInvalid</validator>
			</validation>
			<validation id="2.5" description="The naming of files and folders must be correct." severity="Error">
				<validator type="log" dependingOption="cn-11-2">Path.Invalid</validator>
			</validation>
			<validation id="2.6" description="m1 folder exists, and no files are placed." severity="Error">
				<validator type="log" dependingOption="cn-11-2">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="cn-11-2">File.Extra</validator>
				<validator type="log" dependingOption="cn-11-2">M1Folder.RedundantFiles</validator>
				<validator type="log" dependingOption="cn-11-2">M1Folder.NotExist</validator>
			</validation>
			<validation id="2.7" description="util file folder exists and contained files must be correct." severity="Error">
				<validator type="log" dependingOption="cn-11-2">DtdChecksumFailed</validator>
				<validator type="log" dependingOption="cn-11-2">StyleSheetChecksumFailed</validator>
				<validator type="log" dependingOption="cn-11-2">StyleSheetExist</validator>
				<validator type="log" dependingOption="cn-11-2">InvalidStyleSheetLocation</validator>
				<validator type="log" dependingOption="cn-11-2">IchChecksumFailed</validator>
				<validator type="log" dependingOption="cn-11-2">StfChecksumFailed</validator>
			</validation>
			<validation id="2.8" description="No other files are allowed in sequence root folder" severity="Error">
				<validator type="log" dependingOption="cn-11-2">SubmissionFolder.RedundantFiles</validator>
				<validator type="log" dependingOption="cn-11-2">File.Extra</validator>
				<validator type="log" dependingOption="cn-11-2">M1Folder.RedundantFiles</validator>
			</validation>
			<validation id="2.9" description="Sequence folder requirement" severity="Error">
				<validator type="log" dependingOption="cn-11-2">SequenceNumberCharacters</validator>
			</validation>
			<validation id="2.10" description="Sequence number" severity="Error">
				<validator type="log" dependingOption="cn-11-2">SequenceNumber.IncreasesIncrementally</validator>
			</validation>
		</validation>
		<validation id="3" description="3 - ICH Backbone">
			<validation id="3.1" description="Index.xml file must exist." severity="Error">
				<validator type="log" dependingOption="cn-11-3">Backbone.NotExist</validator>
				<validator type="log" dependingOption="cn-11-3">Regional.Backbone.Multiple</validator>
			</validation>
			<validation id="3.2" 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="cn-11-3">InvalidSchemaOrDtdLocation</validator>
			</validation>
			<validation id="3.3" description="File index.xml must be valid." severity="Error">
				<validator type="log" dependingOption="cn-11-3">Xml</validator>
			</validation>
			<validation id="3.4" description="The file referenced by the cross reference (xlink:href) must exist." severity="Error">
				<validator type="log" dependingOption="cn-11-3">HrefPointToFile.NotExist</validator>
			</validation>
			<validation id="3.5" description="Multiple operations on same document in same sequence are not allowed." severity="Error">
				<validator type="log" dependingOption="cn-11-3">MultipleOperationOnSingleLeaf</validator>
			</validation>
			<validation id="3.6" description="Replaced or appended contents should not be identical to the previous files." severity="Error">
				<validator type="log" dependingOption="cn-11-3">File.ICHCompareContent</validator>
				<validator type="log" dependingOption="cn-11-3">File.CompareContent</validator>
			</validation>
			<validation id="3.7" description="Leaf element: new, replaced or appended leaf elements must have a value for the cross reference (xlink:href)." severity="Error">
				<validator type="log" dependingOption="cn-11-3">BlankHref</validator>
			</validation>
			<validation id="3.8" description="Leaf element: deleted leaf element must have no value for the cross reference (xlink:href)." severity="Error">
				<validator type="log" dependingOption="cn-11-3">DeletedLeaf.Href.NotBlank</validator>
			</validation>
			<validation id="3.9" description="Leaf element: replaced, deleted and appended leaf elements must have a corresponding modified file." severity="Error">
				<validator type="log" dependingOption="cn-11-3">ModifiedFile.Unverifiable</validator>
			</validation>
			<validation id="3.10" description="Leaf element: all files provided in the initial sequence must be in operation ‘New’." severity="Error">
				<validator type="log" dependingOption="cn-11-3">OperationNew</validator>
			</validation>
			<validation id="3.11" description="The modified file must exist." severity="Error">
				<validator type="log" dependingOption="cn-11-3">ModifiedFileNotFound</validator>
			</validation>
			<validation id="3.12" description="Only relative paths can be used in reference." severity="Error">
				<validator type="log" dependingOption="cn-11-3">ModifiedFileRelativePath</validator>
				<validator type="log" dependingOption="cn-11-3">HrefRelativePath</validator>
				<validator type="log" dependingOption="cn-11-3">Attribute.InvalidCharacters</validator>
			</validation>
			<validation id="3.13" description="'checksum-type' attribute" severity="Error">
				<validator type="log" dependingOption="cn-11-3">ChecksumType.Incorrect</validator>
			</validation>
			<validation id="3.14" description="Check of MD5 checksum" severity="Error">
				<validator type="log" dependingOption="cn-11-3">Checksum.Failed</validator>
			</validation>
			<validation id="3.15" description="Check of MD5 checksum for the backbone file" severity="Error">
				<validator type="log" dependingOption="cn-11-3">Index.Checksum.Failed</validator>
			</validation>
			<validation id="3.16" description="Requirements for the use of node extension." severity="Error">
				<validator type="log" dependingOption="cn-11-3">ExistingNodeExtensionsIn32R</validator>
			</validation>
			<validation id="3.17" description="Naming rules of title of node extension" severity="Warning">
				<validator type="log" dependingOption="cn-11-3">NamingConvention32RNodeExtensions</validator>
			</validation>
			<validation id="3.18" description="The leaf title must not be empty" severity="Error">
				<validator type="log" dependingOption="cn-11-3">NodeExtension.Title.Empty</validator>
				<validator type="log" dependingOption="cn-11-3">Leaf.Title.Empty</validator>
			</validation>
			<validation id="3.19" description="The 'delete' leaf title must match the 'deleted' leaf title" severity="Error">
				<validator type="log" dependingOption="cn-11-3">VerifyLeafElementTitle</validator>
			</validation>
			<validation id="3.20" description="No space is added at the beginning or end of the leaf title." severity="Warning">
				<validator type="log" dependingOption="cn-11-3">Leaf.Title.LeadsOrEndsWithSpace</validator>
				<validator type="log" dependingOption="cn-11-3">NodeExtension.Title.LeadsOrEndsWithSpace</validator>
			</validation>
			<validation id="3.21" description="Element must have leaf." severity="Error">
				<validator type="log" dependingOption="cn-11-3">NoneLeafElement</validator>
			</validation>
			<validation id="3.22" description="m1 administrative information and prescribing information must exist." severity="Error">
				<validator type="log" dependingOption="cn-11-3">ICH.M1Root.NotExist</validator>
			</validation>
			<validation id="3.23" description="Use of append" severity="Warning">
				<validator type="log" dependingOption="cn-11-3">CN.AppendOutsideSTF</validator>
			</validation>
			<validation id="3.24" description="File should not be relocated." severity="Error">
				<validator type="log" dependingOption="cn-11-3">ModifiedFile.NotInSameSection</validator>
			</validation>
			<validation id="3.25" description="Attribute-indications" severity="Error">
				<validator type="log" dependingOption="cn-11-3">AttributeMissing</validator>
			</validation>
			<validation id="3.26" description="Attribute-manufacturer" severity="Error">
				<validator type="log" dependingOption="cn-11-3">AttributeMissing</validator>
			</validation>
			<validation id="3.27" description="Attribute-substance" severity="Error">
				<validator type="log" dependingOption="cn-11-3">AttributeMissing</validator>
			</validation>
			<validation id="3.28" description="No space is added at the beginning or end of the attribute value." severity="Warning">
				<validator type="log" dependingOption="cn-11-3">SpaceInAttribute</validator>
			</validation>
			<validation id="3.29" description="Reference to content" severity="Error">
				<validator type="log" dependingOption="cn-11-3">References.AcrossApplication</validator>
			</validation>
			<validation id="3.30" description="Detect invalid life cycle pattern: Append operation causes branches" severity="Error">
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Append</validator>
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Delete</validator>
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Replace</validator>
			</validation>
			<validation id="3.31" description="Detect invalid life cycle pattern: Delete operation causes branches" severity="Error">
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Append</validator>
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Delete</validator>
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Replace</validator>
			</validation>
			<validation id="3.32" description="Detect invalid life cycle pattern: Replace operation causes branches" severity="Error">
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Append</validator>
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Delete</validator>
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.Replace</validator>
			</validation>
			<validation id="3.33" description="Detect invalid life cycle pattern: operation on deleted leaf element" severity="Error">
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCycleOperation.MultipleDelete</validator>
			</validation>
			<validation id="3.34" description="Detect invalid life cycle pattern: Append operation on an appended leaf element" severity="Error">
				<validator type="log" dependingOption="cn-11-3">InvalidLifeCyclePatternAppendOnAppend</validator>
			</validation>
			<validation id="3.35" description="Detect invalid life cycle pattern: Append operation on the STF leaf element that is not the latest" severity="Error">
				<validator type="log" dependingOption="cn-11-3">Stf.AppendOperation</validator>
			</validation>
			<validation id="3.36" description="The language attribute cannot be changed during the replacement operation" severity="Warning">
				<validator type="log" dependingOption="cn-11-3">CN.ICHReplaceWithDifferentLanguage</validator>
		  </validation>
		</validation>
		<validation id="4" description="4 - Regional Information">
			<validation id="4.1" description="4.1 - General">
				<validation id="4.1.1" description="The regional xml file in Module 1 must exist." severity="Error">
					<validator type="log" dependingOption="cn-11-5">Backbone.NotExist</validator>
					<validator type="log" dependingOption="cn-11-5">Regional.Backbone.Multiple</validator>
				</validation>
				<validation id="4.1.2" description="The reference to the schema in cn-regional.xml is directed to the Schema provided in util folder." severity="Error">
					<validator type="log" dependingOption="cn-11-5">InvalidSchemaOrDtdLocation</validator>
				</validation>
				<validation id="4.1.3" description="The regional backbone file must be valid." severity="Error">
					<validator type="log" dependingOption="cn-11-5">Xml</validator>
				</validation>
				<validation id="4.1.4" description="The current sequence must use a schema version that is no lower than that used in the previous sequence" severity="Error">
					<validator type="log" dependingOption="cn-11-5">RegionalDtdVersionPreceding</validator>
				</validation>
				<validation id="4.1.5" description="The file referenced by the attribute of file reference (xlink:href) must exist." severity="Error">
					<validator type="log" dependingOption="cn-11-5">HrefPointToFile.NotExist</validator>
				</validation>
				<validation id="4.1.6" description="Multiple operations on same document in same sequence are not allowed." severity="Error">
					<validator type="log" dependingOption="cn-11-5">MultipleOperationOnSingleLeaf</validator>
				</validation>
				<validation id="4.1.7" description="Replaced or appended contents should not be identical to the previous files." severity="Error">
					<validator type="log" dependingOption="cn-11-5">File.ICHCompareContent</validator>
					<validator type="log" dependingOption="cn-11-5">File.CompareContent</validator>
				</validation>
				<validation id="4.1.8" description="Leaf element: new, replaced or appended leaf elements must have a value of file reference (xlink:href)." severity="Error">
					<validator type="log" dependingOption="cn-11-5">BlankHref</validator>
				</validation>
				<validation id="4.1.9" description="Leaf element: deleted leaf element must have no value of file reference (xlink:href)." severity="Error">
					<validator type="log" dependingOption="cn-11-5">DeletedLeaf.Href.NotBlank</validator>
				</validation>
				<validation id="4.1.10" description="Leaf element: replaced, deleted and appended leaf elements must have a corresponding modified file." severity="Error">
					<validator type="log" dependingOption="cn-11-5">ModifiedFile.Unverifiable</validator>
				</validation>
				<validation id="4.1.11" description="Leaf element: all files provided in the initial sequence must be in operation ‘New’." severity="Error">
					<validator type="log" dependingOption="cn-11-5">OperationNew</validator>
				</validation>
				<validation id="4.1.12" description="'checksum-type' attribute" severity="Error">
					<validator type="log" dependingOption="cn-11-5">ChecksumType.Incorrect</validator>
				</validation>
				<validation id="4.1.13" description="Check of MD5 checksum" severity="Error">
					<validator type="log" dependingOption="cn-11-5">Checksum.Failed</validator>
				</validation>
				<validation id="4.1.14" description="Operation attribute for cover letter" severity="Error">
					<validator type="log" dependingOption="cn-11-5">Operation.InvalidNewOperation</validator>
				</validation>
				<validation id="4.1.15" description="Operation attribute for application form" severity="Error">
					<validator type="log" dependingOption="cn-11-5">Operation.InvalidNewOperation</validator>
				</validation>
				<validation id="4.1.16" description="Use of 'Node Extension' is not allowed." severity="Error">
					<validator type="log" dependingOption="cn-11-5">NodeExtension.Exist</validator>
				</validation>
				<validation id="4.1.17" description="The leaf title must not be empty." severity="Error">
					<validator type="log" dependingOption="cn-11-5">NodeExtension.Title.Empty</validator>
					<validator type="log" dependingOption="cn-11-5">Leaf.Title.Empty</validator>
				</validation>
				<validation id="4.1.18" description="The 'delete' leaf title must match the 'deleted' leaf title." severity="Error">
					<validator type="log" dependingOption="cn-11-5">VerifyLeafElementTitle</validator>
				</validation>
				<validation id="4.1.19" description="No space is added at the beginning or end of the leaf title." severity="Warning">
					<validator type="log" dependingOption="cn-11-5">Leaf.Title.LeadsOrEndsWithSpace</validator>
					<validator type="log" dependingOption="cn-11-5">NodeExtension.Title.LeadsOrEndsWithSpace</validator>
				</validation>
				<validation id="4.1.20" description="There must be a leaf element under the element." severity="Error">
					<validator type="log" dependingOption="cn-11-5">NoneLeafElement</validator>
				</validation>
				<validation id="4.1.21" description="Application folder title" severity="Error">
					<validator type="log" dependingOption="cn-11-5">ApplicationNumberNotMatch</validator>
				</validation>
				<validation id="4.1.22" description="Sequence folder title" severity="Error">
					<validator type="log" dependingOption="cn-11-5">SequenceNumberNotMatch</validator>
				</validation>
				<validation id="4.1.23" description="M1 folder directory structure" severity="Error">
					<validator type="log" dependingOption="cn-11-5">Module1FolderInvalid</validator>
				</validation>
				<validation id="4.1.24" description="Reference to content" severity="Error">
					<validator type="log" dependingOption="cn-11-5">References.AcrossApplication</validator>
				</validation>
				<validation id="4.1.25" description="Detect invalid life cycle pattern: append operation causes branches" severity="Error">
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Append</validator>
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Delete</validator>
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Replace</validator>
				</validation>
				<validation id="4.1.26" description="Detect invalid life cycle pattern: deletion operation causes branches" severity="Error">
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Append</validator>
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Delete</validator>
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Replace</validator>
				</validation>
				<validation id="4.1.27" description="Detect invalid life cycle pattern: replacement operation causes branches" severity="Error">
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Append</validator>
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Delete</validator>
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.Replace</validator>
				</validation>
				<validation id="4.1.28" description="Detect invalid life cycle pattern: operation of the deleted leaf element" severity="Error">
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCycleOperation.MultipleDelete</validator>
				</validation>
				<validation id="4.1.29" description="Detect invalid life cycle pattern: append operation to an appended leaf element" severity="Error">
					<validator type="log" dependingOption="cn-11-5">InvalidLifeCyclePatternAppendOnAppend</validator>
				</validation>
				<validation id="4.1.30" description="Use of append" severity="Warning">
					<validator type="log" dependingOption="cn-11-5">CN.AppendOutsideSTF</validator>
				</validation>
				<validation id="4.1.31" description="The language attribute cannot be changed during the replacement operation" severity="Warning">
					<validator type="log" dependingOption="cn-11-5">CN.RegionalReplaceWithDifferentLanguage</validator>
				</validation>
			</validation>
			<validation id="4.2" description="4.2 - Envelope Information">
				<validation id="4.2.1" description="Envelope element: application number" severity="Error">
					<validator type="log" dependingOption="cn-11-6">ApplicationNumberCharacters</validator>
				</validation>
				<validation id="4.2.2" description="Envelope element: application type" severity="Error">
					<validator type="log" dependingOption="cn-11-6">ApplicationTypeInvalid</validator>
				</validation>
				<validation id="4.2.3" description="Envelope element: product type" severity="Error">
					<validator type="log" dependingOption="cn-11-6">ProductTypeInvalid</validator>
				</validation>
				<validation id="4.2.4" description="Envelope element: original number" severity="Error">
					<validator type="log" dependingOption="cn-11-6">OriginalNumberNoEmpty</validator>
				</validation>
				<validation id="4.2.5" description="Envelope element: related sequence" severity="Error">
					<validator type="log" dependingOption="cn-11-6">RelatedSequenceNumber.Lower</validator>
					<validator type="log" dependingOption="cn-11-6">RelatedSequenceNumber.Characters</validator>
				</validation>
				<validation id="4.2.6" description="Envelope element: regulatory activity type" severity="Error">
					<validator type="log" dependingOption="cn-11-6">CN.InvalidRegulartoryActivityType</validator>
				</validation>
				<validation id="4.2.7" description="Envelope element: sequence number" severity="Error">
					<validator type="log" dependingOption="cn-11-6">SequenceNumberCharacters</validator>
				</validation>
				<validation id="4.2.8" description="Envelope element: sequence type" severity="Error">
					<validator type="log" dependingOption="cn-11-6">InvalidSequenceType</validator>
				</validation>
				<validation id="4.2.9" description="Envelope element: sequence description" severity="Error">
					<validator type="log" dependingOption="cn-11-6">SequenceDescriptionNoEmpty</validator>
				</validation>
				<validation id="4.2.10" description="Envelope element: sequence correlation information" severity="Error">
					<validator type="log" dependingOption="cn-11-6">CN.InvalidCorrelationAmongAppTypeRATypeAndSeqType</validator>
				</validation>
				<validation id="4.2.11" description="Value of correlation sequence" severity="Error">
					<validator type="log" dependingOption="cn-11-6">CN.SequenceTypeMustNotHaveRelatedSequence</validator>
				</validation>
				<validation id="4.2.12" description="Value of correlation sequence" severity="Error">
					<validator type="log" dependingOption="cn-11-6">CN.SequenceTypeMustHaveRelatedSequence</validator>
				</validation>
				<validation id="4.2.13" description="Envelope element at application level must remain unchanged" severity="Error">
					<validator type="log" dependingOption="cn-11-6">AppNumberAndTypeUnchanged</validator>
				</validation>
				<validation id="4.2.14" description="The type of regulatory activity must remain unchanged" severity="Error">
					<validator type="log" dependingOption="cn-11-6">RegBehavior4214</validator>
				</validation>
			</validation>
			<validation id="4.3" description="4.3 - Content Integrity">
				<validation id="4.3.1" description="Integrity validation of Module 1:&#xA;Application type: New Drug Application&#xA;Regulatory activity type: Original Application or New Indication&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsRequired431</validator>
				</validation>
				<validation id="4.3.2" description="Integrity validation of Module 1:&#xA;Application type: New Drug Application&#xA;Regulatory activity type: Original Application or New Indication&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsNotRequired432</validator>
				</validation>
				<validation id="4.3.3" description="Integrity validation of Module 1:&#xA;Application type: Abbreviated New Drug Application&#xA;Regulatory activity type: Original Application or New Indication&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementSubmitted433</validator>
				</validation>
				<validation id="4.3.4" description="Integrity validation of Module 1:&#xA;Application type: Abbreviated New Drug Application&#xA;Regulatory activity type: Original Application or New Indication&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementNotSubmitted434</validator>
				</validation>
				<validation id="4.3.5" description="Integrity validation of Module 1:&#xA;Application type: Investigational New Drug&#xA;Regulatory activity type: Original Application or New Indication and Drug Combination&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsRequired435</validator>
				</validation>
				<validation id="4.3.6" description="Integrity validation of Module 1:&#xA;Application type: Investigational New Drug&#xA;Regulatory activity type: Original Application or New Indication and Drug Combination&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsNotRequired436</validator>
				</validation>
				<validation id="4.3.7" description="Integrity validation of Module 1:&#xA;Application type: Investigational New Drug&#xA;Regulatory activity type: Development Safety Report&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsRequired437</validator>
				</validation>
				<validation id="4.3.8" description="Integrity validation of Module 1:&#xA;Application type: Investigational New Drug&#xA;Regulatory activity type: Development Safety Report&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsNotRequired438</validator>
				</validation>
				<validation id="4.3.9" description="Number of leaf elements contained in an element" severity="Information">
				<validator type="log" dependingOption="cn-11-7">ElementsRequired439</validator>
				</validation>
				<validation id="4.3.10" description="Integrity validation of Module 1:&#xA;Application type: Drug Substance Application&#xA;Regulatory activity type: Original Application&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsRequired4310</validator>
				</validation>
				<validation id="4.3.11" description="Integrity validation of Module 1:&#xA;Application type: Drug Substance Application&#xA;Regulatory activity type: Original Application&#xA;Sequence type: Original" severity="Error">
				<validator type="log" dependingOption="cn-11-7">ElementsNotRequired4311</validator>
				</validation>
			</validation>
		</validation>
		<validation id="5" description="5 - Study Tagging File (STF)">
			<validation id="5.1" description="STF file must be valid." severity="Error">
				<validator type="log" dependingOption="cn-11-8">Xml</validator>
			</validation>
			<validation id="5.2" description="Check the index reference." severity="Error">
				<validator type="log" dependingOption="cn-11-8">StfHrefHasBackslashes</validator>
			</validation>
			<validation id="5.3" description="'content-block' element is not recommended." severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.ContentBlock.NotAccepted</validator>
			</validation>
			<validation id="5.4" description="File reference must not use backslash." severity="Error">
				<validator type="log" dependingOption="cn-11-8">StfHrefHasBackslashes</validator>
			</validation>
			<validation id="5.5" description="The category element of study identifier can’t be empty." severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.Categories.Empty</validator>
			</validation>
			<validation id="5.6" description="Study ID of the study identifier can’t be empty." severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.StudyId.Empty</validator>
			</validation>
			<validation id="5.7" description="The title of the study identifier must match the leaf title of the leaf element" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.Title.NotMatch</validator>
			</validation>
			<validation id="5.8" description="Tag attribute and category element value" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.FileTag.NotSupported</validator>
				<validator type="log" dependingOption="cn-11-8">Stf.Category.NotSupported</validator>
			</validation>
			<validation id="5.9" description="STF append operation" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.Append.ReferenceOtherStf</validator>
			</validation>
			<validation id="5.10" description="Category information must be provided for STF" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.Category.Missing</validator>
			</validation>
			<validation id="5.11" description="STF can’t reference another STF." severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.ReferenceStf</validator>
			</validation>
			<validation id="5.12" description="STF file must reference at least one leaf element." severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.NotHasReferencedLeaf</validator>
			</validation>
			<validation id="5.13" description="'study-id' of STF must remain consistent." severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.StudyId.NotMatch</validator>
			</validation>
			<validation id="5.14" description="Invalid STF Table of Content position" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.WrongSection</validator>
			</validation>
			<validation id="5.15" description="STF 'doc-content' file-tag count" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.FileTag.NotExist1</validator>
			</validation>
			<validation id="5.16" description="Section 5.3.7 Case Report Form structure" severity="Error">
				<validator type="log" dependingOption="cn-11-8">CaseReportFormsReference</validator>
			</validation>
			<validation id="5.17" description="Use of STF." severity="Error">
				<validator type="log" dependingOption="cn-11-8">Stf.Adoption</validator>
			</validation>
			<validation id="5.18" description="STF file tags must be correctly used for relevant files in clinical trial database" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.StfFileTagDatasetDefineXmlNotValid</validator>
			</validation>
			<validation id="5.19" description="Correct datasets and data definition files are essential for clinical trial data from the applicant" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.ElectronicFormatM5</validator>
			</validation>
			<validation id="5.20" description="Databases submitted for the same study shall feature different names" severity="Warning">
				<validator type="log" dependingOption="cn-11-8">Stf.STFSameStudyidAndFiletagHavingSameName</validator>
			</validation>
		</validation>
		<validation id="6" description="6 - PDF Analysis">
			<validation id="6.1" description="PDF file must be eligible to read." severity="Error">
				<validator type="log" dependingOption="cn-11-9">Pdf.Failed</validator>
			</validation>
			<validation id="6.2" description="The bookmark must direct to the relative path." severity="Error">
				<validator type="log" dependingOption="cn-11-9">AbsolutePathInPdfBookmarks</validator>
			</validation>
			<validation id="6.3" description="The bookmark with a webpage or an email destination or other external links." severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfExternalDestinationBookmark</validator>
				<validator type="log" dependingOption="cn-11-9">ExternalBookmark</validator>
			</validation>
			<validation id="6.4" description="The bookmark with unknown action is not allowed." severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfUnknownActionBookmark</validator>
			</validation>
			<validation id="6.5" description="The bookmark must not be inactive." severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfInactiveBookmark</validator>
			</validation>
			<validation id="6.6" description="The bookmark must not be broken." severity="Error">
				<validator type="log" dependingOption="cn-11-9">BookmarkBrokenLinkInPdf</validator>
			</validation>
			<validation id="6.7" description="The bookmark must not have multiple actions." severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfMultipleActionBookmark</validator>
			</validation>
			<validation id="6.8" description="The bookmark attribute must be ’Inherit Zoom’." severity="Warning">
				<validator type="log" dependingOption="cn-11-9">Bookmark.Pdf.InvalidMagnification</validator>
			</validation>
			<validation id="6.9" description="Hypertext links should use relative paths" severity="Warning">
				<validator type="log" dependingOption="cn-11-9">AbsolutePathInPdfLinks</validator>
			</validation>
			<validation id="6.10" description="Webpage or email or other external links’ hypertext links" severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfExternalDestinationHyperLink</validator>
				<validator type="log" dependingOption="cn-11-9">Pdf.UseURLLink</validator>
			</validation>
			<validation id="6.11" description="The hypertext links with unknown actions should not be used" severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfUnknownAction</validator>
			</validation>
			<validation id="6.12" description="Hypertext links should not be inactive" severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfInactiveBookmarkHyperlink</validator>
			</validation>
			<validation id="6.13" description="The hypertext link should not be broken" severity="Error">
				<validator type="log" dependingOption="cn-11-9">BrokenLinkInPdf</validator>
			</validation>
			<validation id="6.14" description="The hypertext links should not have multiple actions" severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfMultipleActionLink</validator>
			</validation>
			<validation id="6.15" description="The hypertext links attribute should be ’Inherit Zoom’" severity="Warning">
				<validator type="log" dependingOption="cn-11-9">Pdf.InvalidMagnification</validator>
			</validation>
			<validation id="6.16" description="PDF version should be correct." severity="Warning">
				<validator type="log" dependingOption="cn-11-9">Pdf.UnsupportedPdfVersion</validator>
			</validation>
			<validation id="6.17" description="The PDF document with attachments is not allowed." severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfAttachmentDetected</validator>
			</validation>
			<validation id="6.18" description="Annotated PDF document" severity="Information">
				<validator type="log" dependingOption="cn-11-9">PdfAnnotations</validator>
			</validation>
			<validation id="6.19" description="PDF files cannot have any security settings" severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfSecurity</validator>
			</validation>
			<validation id="6.20" description="PDF initial view should be correct." severity="Warning">
				<validator type="log" dependingOption="cn-11-9">Pdf.InvalidInitialView</validator>
				<validator type="log" dependingOption="cn-11-9">Pdf.InvalidInitialView.Bookmark</validator>
			</validation>
			<validation id="6.21" description="PDF document must not have password protection." severity="Error">
				<validator type="log" dependingOption="cn-11-9">PdfSecurity</validator>
			</validation>
			<validation id="6.22" description="PDF should have 'Fast Web Access' active." severity="Information">
				<validator type="log" dependingOption="cn-11-9">PdfFastWebAccess</validator>
			</validation>
			<validation id="6.23" description="The document consisting of more than 5 pages should have bookmarks." severity="Error">
				<validator type="log" dependingOption="cn-11-9">Pdf.Bookmark</validator>
				<validator type="log" dependingOption="cn-11-9">Consistent.PageAndBookmark</validator>
			</validation>
			<validation id="6.24" description="Restriction in PDF contents" severity="Warning">
				<validator type="log" dependingOption="cn-11-9">Pdf.RestrictedContents</validator>
			</validation>
			<validation id="6.25" description="PDF Content should be searchable" severity="Warning">
				<validator type="log" dependingOption="cn-11-9">PdfDocContainsNoText</validator>
			</validation>
			<validation id="6.26" description="If non-standard fonts are used, they should be embedded in PDF files." severity="Warning">
				<validator type="log" dependingOption="cn-11-9">PdfNonStandardFont</validator>
			</validation>
		</validation>
		<validation id="7" 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="cn-11-10">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="cn-11-10">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="cn-11-10">Index.Checksum.InvalidFormat</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the bookmark pane is not visible ('initial view' of the document is set to 'Page Only’) when the pdf document does not contain bookmark(s)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">InvalidPageModeWhenNoBookmark</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="cn-11-10">LeafId.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the same Sequence Number is not already used in the application (including folder name)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">SameSequenceNumber</validator>
			</validation>
			<validation id="Recommended" description="Ensure that for all leafs in the submission, file names (including extension) and/or folder names does not exceed 64 characters." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">LongFileName</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the leaf element path does not exceed max number of character length allowed for that region" severity="Warning">
				<validator type="log" dependingOption="cn-11-10">LongPath</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="cn-11-10">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="cn-11-10">ModifiedFile.IncorrectSyntax</validator>
			</validation>
			<validation id="Recommended" description="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'" severity="Warning">
				<validator type="log" dependingOption="cn-11-10">ModifiedFileExist</validator>
      </validation>
      <validation id="Recommended" description="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." severity="Warning">
        <validator type="log" dependingOption="cn-11-10">NamingConvention.Inconsistent</validator>
        <validator type="log" dependingOption="cn-11-10">M1.NamingConvention.NotMatch</validator>
      </validation>
			<validation id="Recommended" description="Ensure that one and only one index-md5.txt file exists and is placed in the correct location (i.e.  &lt;app-id&gt;\&lt;seq-num&gt;\index-md5.txt)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">SubmissionChecksum.Failed</validator>
			</validation>
      <validation id="Recommended" description="Ensure that index MD5 txt file is named correctly (i.e. index-md5.txt)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">SubmissionChecksumFileName.Failed</validator>
			</validation>
			<validation id="Recommended" description="Ensure that ICH and regional xml backbone files are named correctly." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">EU_CH_GC_AUBackbone.NotExist</validator>
			</validation>
			<validation id="Recommended" description="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. &lt;app-id&gt;\&lt;seq-num&gt;\util\dtd) and these files are named correctly." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">UtilFilesInvalidPath</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="cn-11-10">AccessibleFileFolder</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the ICH DTD versions used in the current sequence (sequence being tested) is equal to or higher than the DTD version used in the numerically preceding sequence of the application" severity="Warning">
				<validator type="log" dependingOption="cn-11-10">IchDtdVersionPreceding</validator>
			</validation>
			<validation id="Recommended" description="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)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">PdfBackslash</validator>
				<validator type="log" dependingOption="cn-11-10">PdfBackslashBookmark</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="cn-11-10">RefOutsideSeqOrApp</validator>
				<validator type="log" dependingOption="cn-11-10">RefOutsideSeqOrAppBookmark</validator>
			</validation>
			<validation id="Recommended" description="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." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">IchDtdVersionSucceeding</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the regional DTD version used in the current sequence (sequence being tested) is equal to or lower than the DTD version used in the numerically succeeding sequence of the application." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">RegionalDtdVersionSucceeding</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="cn-11-10">PdfTotalNonRelativeBookmarks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalWebEmailDestinationBookmarks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalExternalDestinationBookmarks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalUnknownActionBookmarks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalInActiveBookmarks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalBrokenBookmarks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfNumberOfBookmarksPerDocument</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalBookmarksInSubmission</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalNonRelativeHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalWebEmailDestinationHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalExternalDestinationHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalUnknownActionHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalInActiveHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalBrokenHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">PdfTotalHyperLinks</validator>
				<validator type="log" dependingOption="cn-11-10">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="cn-11-10">RefDocCorrupted</validator>
				<validator type="log" dependingOption="cn-11-10">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="cn-11-10">BlankLinkInPdf</validator>
				<validator type="log" dependingOption="cn-11-10">BlankLinkInPdfBookmark</validator>
			</validation>
			<validation id="Recommended" description="Ensure that application form is submitted in the correct location of the TOC." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">ApplicationForm.IncorrectLocation</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="cn-11-10">Stf.PropertyBeforeFiletag</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="cn-11-10">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="cn-11-10">Stf.ReferencedMultiple</validator>
			</validation>
			<validation id="Recommended" description="Ensure that 'title' element (within 'study-identifier') is present and value for title is provided in the STF xml file." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.Title.Empty</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="cn-11-10">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="cn-11-10">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="cn-11-10">InvalidStfFileName</validator>
			</validation>
			<validation id="Recommended" description="Ensure that files referenced by an STF exist in the submission/application (referenced by index.xml)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.LeafId.NotExist</validator>
			</validation>
			<validation id="Recommended" description="Ensure that valid STF DTD version (e.g. dtd-version = &apos;2.2&apos;) is referenced in the STF XML file." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.UnsupportedSchemaVersion</validator>
			</validation>
			<validation id="Recommended" description="Ensure that valid STF DTD version (e.g. version = &apos;STF Version 2.2&apos;) is listed in the index.xml file for stf leaf element." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.UnsupportedDtdVersion</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF DTD version in stf xml file (i.e. dtd-version = &apos;2.2&apos;) must match the stf dtd version specified for the stf leaf in index.xml file (i.e. version = &apos;STF Version 2.2&apos;)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.DtdVersionNotMatch</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF DTD version (e.g. dtd-version = &apos;2.2&apos;) is specified in the STF XML file." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.MissingDtdAttribute</validator>
			</validation>
			<validation id="Recommended" description="Ensure that STF DTD version (e.g. version = &apos;STF Version 2.2&apos;) is specified in the index.xml file for stf leaf element." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.MissingDtdVersion</validator>
			</validation>
			<validation id="Recommended" description="Ensure that stf xml file is not cumulative information." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.Cumulative</validator>
			</validation>
			<validation id="Recommended" description="Ensure that leaf 'title' and/or 'keyword' (if present) are no longer than 512 characters." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Title.TooLong</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="cn-11-10">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="cn-11-10">IchDtdVersion</validator>
				<validator type="log" dependingOption="cn-11-10">RegionalDtdVersion</validator>
			</validation>
			<validation id="Recommended" description="Ensure extraneous attributes (i.e. 'manufacturer' attribute is referenced in m4 or m5 section, or 'species' attribute is referenced in m5 STF) are not specified in the xml backbone files." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">ExtraneousAttribute</validator>
			</validation>
			<validation id="Recommended" description="Ensure that an attribute is not referenced multiple times in an STF (i.e. two ‘type-of-control ‘)." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.Category.Duplicate</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="cn-11-10">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="cn-11-10">InvalidLeafOperation</validator>
			</validation>
			<validation id="Recommended" description="Ensure that the titles from the doc-content elements (if present) must match the corresponding leaf title values in the ICH backbone." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.DocContent.Title.NotMatch</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="cn-11-10">Href.Reused</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="cn-11-10">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="cn-11-10">References.FilesOutsideApplication</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="cn-11-10">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="cn-11-10">InitialSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Print the listing of all STFs in the submission." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">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="cn-11-10">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="cn-11-10">CA.HighestSequence.Invalid</validator>
			</validation>
			<validation id="Recommended" description="Print the list of all encrypted documents in the submission." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">PdfEncryptedDocument</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="cn-11-10">RegionalBackboneReferenced.WrongOperationAttribute</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="cn-11-10">Xml.StyleSheet</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="cn-11-10">Stf.TrialSummary.Present</validator>
			</validation>
			<validation id="Recommended" description="Ensure that for each dataset (filename configured) type there is only one leaf referenced in an STF is of operation type 'new'." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">Stf.FileName.Specific</validator>
			</validation>
			<validation id="Recommended" description="Ensure ICH attributes must not contain leading or trailing spaces, nor start or end with hyphens." severity="Warning">
				<validator type="log" dependingOption="cn-11-10">ICH.Attributes</validator>
			</validation>
			<validation id="Recommended" description="Ensure that two leaf elements should not have the same leaf ID" severity="Warning">
				<validator type="log" dependingOption="cn-11-10">SameLeafId</validator>
			</validation>
			<validation id="Recommended" description="Ensure 'Cover Letter' is required for CN region" severity="Error">
				<validator type="log" dependingOption="cn-11-10">File.CoverLetter.NotFound</validator>
			</validation>
		</validation>
	</validations>
</validationreport>