﻿<?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="SG Criteria">
		<validation id="1" description="1 - eCTD XML Identification">
			<validation id="1.1a" description="XML Backbones Identification" severity="Error">
				<validator type="log" dependingOption="sg-10-1">Backbone.NotExist</validator>
				<validator type="log" dependingOption="sg-10-1">Regional.Backbone.Multiple</validator>
				<validator type="log" dependingOption="sg-10-1">EU_CH_GC_AUBackbone.NotExist</validator>
				<validator type="log" dependingOption="sg-10-1">IchDtdVersionPreceding</validator>
				<validator type="log" dependingOption="sg-10-1">RegionalDtdVersionPreceding</validator>
				<validator type="log" dependingOption="sg-10-1">IchDtdVersionSucceeding</validator>
				<validator type="log" dependingOption="sg-10-1">RegionalDtdVersionSucceeding</validator>
			</validation>
			<validation id="1.1b" description="HTML Rendition of Regional Backbone" severity="Information">
				<validator type="log" dependingOption="sg-10-1">ChecksumInRegionlHtml</validator>
			</validation>
			<validation id="1.2" description="STF Identification" severity="Error">
				<validator type="log" dependingOption="sg-10-1">Stf.List</validator>
			</validation>
		</validation>
		<validation id="2" description="2 - Files/Folders">
			<validation id="2.1" description="2.1 Folders">
				<validation id="2.1.1" description="Folder name syntax must be correct" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">LongFileName</validator>
					<validator type="log" dependingOption="sg-10-2-1">Path.Invalid</validator>
				</validation>
				<validation id="2.1.2" description="Folders must not be empty" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">EmptyFolder</validator>
				</validation>
				<validation id="2.1.3" description="Sequence Root folder does not contain unspecified files" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">File.Extra</validator>
					<validator type="log" dependingOption="sg-10-2-1">SubmissionFolder.RedundantFiles</validator>
				</validation>
				<validation id="2.1.4" description="Folder m1 exists and no files are placed there." severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">M1Folder.RedundantFiles</validator>
				</validation>
				<validation id="2.1.5" description="Only folders m2, m3, m4, m5 and util exist" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">File.Extra</validator>
				</validation>
				<validation id="2.1.6" description="Folder util exists and contained files are correct" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">StfChecksumFailed</validator>
					<validator type="log" dependingOption="sg-10-2-1">Util.NotExisted</validator>
					<validator type="log" dependingOption="sg-10-2-1">IchChecksumFailed</validator>
					<validator type="log" dependingOption="sg-10-2-1">DtdChecksumFailed</validator>
          <validator type="log" dependingOption="sg-10-2-1">StyleSheetChecksumFailed</validator>
					<validator type="log" dependingOption="sg-10-2-1">UtilFilesInvalidPath</validator>
					<validator type="log" dependingOption="sg-10-2-1">File.Extra.InUtil</validator>
					<validator type="log" dependingOption="sg-10-2-1">Folder.Extra.InUtil</validator>
				</validation>
				<validation id="2.1.7" description="Sequence folder should be four digits" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">SequenceNumberCharacters</validator>
				</validation>
				<validation id="2.1.8" description="Applications should start with sequence folder 0001" severity="Error">
					<validator type="log" dependingOption="sg-10-2-1">InitialSequence.Invalid</validator>
					<validator type="log" dependingOption="sg-10-2-1">FirstSequence.Invalid</validator>
				</validation>
			</validation>
			<validation id="2.2" description="2.2 Files">
				<validation id="2.2.1" description="File name syntax must be correct" severity="Error">
					<validator type="log" dependingOption="sg-10-2-2">LongFileName</validator>
					<validator type="log" dependingOption="sg-10-2-2">Path.Invalid</validator>
					<validator type="log" dependingOption="sg-10-2-2">LongPath</validator>
				</validation>
				<validation id="2.2.2" description="Unreferenced files are not allowed" severity="Error">
					<validator type="log" dependingOption="sg-10-2-2">File.Extra</validator>
				</validation>
				<validation id="2.2.3" description="File size limits should not be exceeded" severity="Warning">
					<validator type="log" dependingOption="sg-10-2-2">File.Size</validator>
					<validator type="log" dependingOption="sg-10-2-2">SpecialFile.Size</validator>
				</validation>
				<validation id="2.2.4" description="File types (file extensions) check" severity="Error">
					<validator type="log" dependingOption="sg-10-2-2">InconsistentExtensions</validator>
					<validator type="log" dependingOption="sg-10-2-2">FileType.Invalid</validator>
				</validation>
			</validation>
		</validation>
		<validation id="3" description="3 - ICH Backbone">
			<validation id="3.1" description="3.1 The index.xml">
				<validation id="3.1.1" description="File index.xml must exist" severity="Error">
					<validator type="log" dependingOption="sg-10-3-1">Backbone.NotExist</validator>
					<validator type="log" dependingOption="sg-10-3-1">Regional.Backbone.Multiple</validator>
				</validation>
				<validation id="3.1.2" description="The index.xml file must be valid" severity="Error">
					<validator type="log" dependingOption="sg-10-3-1">Xml</validator>
				</validation>
			</validation>
			<validation id="3.2" description="3.2 MD5 Checksum">
				<validation id="3.2.1" description="Attribute checksum-type" severity="Error">
					<validator type="log" dependingOption="sg-10-3-2">ChecksumType.Incorrect</validator>
				</validation>
				<validation id="3.2.2" description="MD5 Checksum" severity="Error">
					<validator type="log" dependingOption="sg-10-3-2">Checksum.Failed</validator>
				</validation>
				<validation id="3.2.3" description="MD5 for Index file" severity="Error">
					<validator type="log" dependingOption="sg-10-3-2">Index.Checksum.Failed</validator>
				</validation>
			</validation>
			<validation id="3.3" description="3.3 References">
				<validation id="3.3.1" 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="sg-10-3-3">InvalidSchemaOrDtdLocation</validator>
				</validation>
				<validation id="3.3.2" description="The files referenced by the cross reference (xlink:href) must exist " severity="Error">
					<validator type="log" dependingOption="sg-10-3-3">HrefPointToFile.NotExist</validator>
				</validation>
				<validation id="3.3.3" description="Only relative references are being used" severity="Error">
					<validator type="log" dependingOption="sg-10-3-3">Attribute.InvalidCharacters</validator>
					<validator type="log" dependingOption="sg-10-3-3">HrefRelativePath</validator>
					<validator type="log" dependingOption="sg-10-3-3">ModifiedFileRelativePath</validator>
				</validation>
				<validation id="3.3.4" description="References to targets outside Application" severity="Information">
					<validator type="log" dependingOption="sg-10-3-3">References.FilesOutsideApplication</validator>
				</validation>
				<validation id="3.3.5" description="References to targets outside Sequence" severity="Information">
					<validator type="log" dependingOption="sg-10-3-3">References.FilesOutsideSequence</validator>
				</validation>
			</validation>
			<validation id="3.4" description="3.4 Heading Elements, Leaves and Node Extensions">
				<validation id="3.4.1" description="m1-administrative element must exist" severity="Error">
					<validator type="log" dependingOption="sg-10-3-4">ICH.M1Root.NotExist</validator>
				</validation>
				<validation id="3.4.2" description="Element must have leaf" severity="Error">
					<validator type="log" dependingOption="sg-10-3-4">FolderEmpty</validator>
				</validation>
				<validation id="3.4.3" description="Required Attribute value checks" severity="Error">
					<validator type="log" dependingOption="sg-10-3-4">ICHMetadataAttribute.EmptyValue</validator>
				</validation>
				<validation id="3.4.4" description="Optional Attribute value checks" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-4">ICHMetadataAttribute.EmptyValue.Optional</validator>
				</validation>
				<validation id="3.4.5" description="Leaf title must not be empty" severity="Error">
					<validator type="log" dependingOption="sg-10-3-4">Leaf.Title.Empty</validator>
				</validation>
				<validation id="3.4.6" description="Node Extensions are appropriately placed" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-4">NodeExtensionAppropriatelyPlaced</validator>
				</validation>
				<validation id="3.4.7" description="Node Extension title must not be empty" severity="Error">
					<validator type="log" dependingOption="sg-10-3-4">NodeExtension.Title.Empty</validator>
				</validation>
				<validation id="3.4.8" description="Node Extension exists for all Clinical Studies" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-4">NodeExtensionsInModule53</validator>
				</validation>
				<validation id="3.4.9" description="Node Extension naming convention for content provided in 5.3.6" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-4">NodeExtensionsInModule536</validator>
				</validation>
				<validation id="3.4.10" description="Node Extension elements in 3.2.R" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-4">LeafElementsIn32R</validator>
				</validation>
				<validation id="3.4.11" description="Node Extension naming convention for content provided in 3.2.R" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-4">NamingConventionNodeExtensions</validator>
				</validation>
			</validation>
			<validation id="3.5" description="3.5 Life Cycle Management">
				<validation id="3.5.1" description="Multiple operations on the same document in the same Sequence are not allowed" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">MultipleOperationOnSingleLeaf</validator>
				</validation>
				<validation id="3.5.2" description="Leaf operation attribute" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">ModifiedFile.Unverifiable</validator>
					<validator type="log" dependingOption="sg-10-3-5">DeletedLeaf.Href.NotBlank</validator>
					<validator type="log" dependingOption="sg-10-3-5">BlankHref</validator>
					<validator type="log" dependingOption="sg-10-3-5">OperationNew</validator>
				</validation>
				<validation id="3.5.3" description="Modified file existence" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">ModifiedFileNotFound</validator>
				</validation>
				<validation id="3.5.4" description="Use of Append" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">AppendOutsideSTF</validator>
				</validation>
				<validation id="3.5.5" description="Detect invalid lifecycle pattern: Append operations causing branches" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">InvalidLifeCycleOperation.Append</validator>
				</validation>
				<validation id="3.5.6" description="Detect invalid lifecycle pattern: Delete operations causing branches" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">InvalidLifeCycleOperation.Delete</validator>
				</validation>
				<validation id="3.5.7" description="Detect invalid lifecycle pattern: Replace operations causing branches" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">InvalidLifeCycleOperation.Replace</validator>
				</validation>
				<validation id="3.5.8" description="Detect invalid lifecycle pattern: Operation on deleted leaf content" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">InvalidLifeCycleOperation.MultipleDelete</validator>
				</validation>
				<validation id="3.5.9" description="Detect invalid lifecycle pattern: Append operations not appending to most recent STF leaf" severity="Error">
					<validator type="log" dependingOption="sg-10-3-5">Stf.AppendOperation</validator>
				</validation>
				<validation id="3.5.10" description="Replace should not provide content identical to the previous file" severity="Warning">
					<validator type="log" dependingOption="sg-10-3-5">File.CompareContent</validator>
				</validation>
				<validation id="3.5.11" description="ICH File reuse" severity="Information">
					<validator type="log" dependingOption="sg-10-3-5">Href.Reused</validator>
				</validation>
			</validation>
			<validation id="3.5" description="3.6 File Existence">
				<validation id="3.6.1" description="Missing Content in section 3.2.S" severity="Information">
					<validator type="log" dependingOption="sg-10-3-6">SectionsMissingContentIn32S</validator>
				</validation>
				<validation id="3.6.2" description="Missing Content in section 3.2.P" severity="Information">
					<validator type="log" dependingOption="sg-10-3-6">SectionsMissingContentIn32P</validator>
				</validation>
			</validation>
		</validation>
		<validation id="4" description="4 - Singapore Regional">
			<validation id="4.1" description="4.1 The regional.xml">
				<validation id="4.1.1" description="Module 1 (regional xml file) exists" severity="Error">
					<validator type="log" dependingOption="sg-10-4-1">Backbone.NotExist</validator>
					<validator type="log" dependingOption="sg-10-4-1">Regional.Backbone.Multiple</validator>
				</validation>
				<validation id="4.1.2" description="The regional backbone file must be valid." severity="Error">
					<validator type="log" dependingOption="sg-10-4-1">Xml</validator>
				</validation>
			</validation>
			<validation id="4.2" description="4.2 MD5 Checksum">
				<validation id="4.2.1" description="MD5 Checksum" severity="Error">
					<validator type="log" dependingOption="sg-10-4-2">Checksum.Failed</validator>
				</validation>
				<validation id="4.2.2" description="Attribute checksum-type" severity="Error">
					<validator type="log" dependingOption="sg-10-4-2">ChecksumType.Incorrect</validator>
				</validation>
			</validation>
			<validation id="4.3" description="4.3 References">
				<validation id="4.3.1" description="The reference to the Schema in sg-regional.xml is directed to the Schema provided in the util folder." severity="Error">
					<validator type="log" dependingOption="sg-10-4-3">InvalidSchemaOrDtdLocation</validator>
				</validation>
				<validation id="4.3.2" description="The files referenced by the cross reference must exist" severity="Error">
					<validator type="log" dependingOption="sg-10-4-3">HrefPointToFile.NotExist</validator>
				</validation>
				<validation id="4.3.3" description="Only relative references are being used" severity="Error">
					<validator type="log" dependingOption="sg-10-4-3">Attribute.InvalidCharacters</validator>
          <validator type="log" dependingOption="sg-10-4-3">HrefRelativePath</validator>
          <validator type="log" dependingOption="sg-10-4-3">ModifiedFileRelativePath</validator>
				</validation>
				<validation id="4.3.4" description="References to targets outside Application" severity="Information">
					<validator type="log" dependingOption="sg-10-4-3">References.FilesOutsideApplication</validator>
				</validation>
				<validation id="4.3.5" description="References to targets outside Sequence" severity="Information">
					<validator type="log" dependingOption="sg-10-4-3">References.FilesOutsideSequence</validator>
				</validation>
			</validation>
			<validation id="4.4" description="4.4 Heading Elements, Leaves and Node Extensions">
				<validation id="4.4.1" description="Element must have leaf" severity="Error">
					<validator type="log" dependingOption="sg-10-4-4">FolderEmpty</validator>
				</validation>
				<validation id="4.4.2" description="Leaf title must not be empty" severity="Error">
					<validator type="log" dependingOption="sg-10-4-4">Leaf.Title.Empty</validator>
				</validation>
				<validation id="4.4.3" description="Node Extensions are appropriately placed" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-4">CA.NotAllowExtensionM1</validator>
				</validation>
				<validation id="4.4.4" description="Node Extension title must not be empty" severity="Error">
					<validator type="log" dependingOption="sg-10-4-4">NodeExtension.Title.Empty</validator>
				</validation>
				<validation id="4.4.5" description="Nested Node Extensions" severity="Error">
					<validator type="log" dependingOption="sg-10-4-4">NotAllowNestedNodeExtension</validator>
				</validation>
			</validation>
			<validation id="4.5" description="4.5 Life Cycle Management">
				<validation id="4.5.1" description="Multiple operations on same document in same Sequence are not allowed" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">MultipleOperationOnSingleLeaf</validator>
				</validation>
				<validation id="4.5.2" description="Leaf operations" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">ModifiedFile.Unverifiable</validator>
					<validator type="log" dependingOption="sg-10-4-5">DeletedLeaf.Href.NotBlank</validator>
					<validator type="log" dependingOption="sg-10-4-5">BlankHref</validator>
					<validator type="log" dependingOption="sg-10-4-5">OperationNew</validator>
				</validation>
				<validation id="4.5.3" description="Modified file existence" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">ModifiedFileNotFound</validator>
				</validation>
				<validation id="4.5.4" description="Use of Append" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">AppendOutsideSTF</validator>
				</validation>
				<validation id="4.5.5" description="Detect invalid lifecycle pattern: Append operations causing branches" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">InvalidLifeCycleOperation.Append</validator>
				</validation>
				<validation id="4.5.6" description="Detect invalid lifecycle pattern: Delete operations causing branches" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">InvalidLifeCycleOperation.Delete</validator>
				</validation>
				<validation id="4.5.7" description="Detect invalid lifecycle pattern: Replace operations causing branches" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">InvalidLifeCycleOperation.Replace</validator>
				</validation>
				<validation id="4.5.8" description="Detect invalid lifecycle pattern: Operation on deleted leaf content" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">InvalidLifeCycleOperation.MultipleDelete</validator>
				</validation>
				<validation id="4.5.9" description="Replace should not provide content identical to the previous file" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">File.CompareContent</validator>
				</validation>
				<validation id="4.5.10" description="Regional File Reuse" severity="Information">
					<validator type="log" dependingOption="sg-10-4-5">Href.Reused</validator>
				</validation>
				<validation id="4.5.11" description="Cover Letter operation attribute" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">Operation.CoverLetter</validator>
				</validation>
				<validation id="4.5.12" description="Note to Evaluator operation attribute" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.NoteToEval</validator>
				</validation>
				<validation id="4.5.13" description="Checklists operation attribute (including all subnodes)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.ProofAndOthers</validator>
				</validation>
				<validation id="4.5.14" description="Table of Summary of Changes operation attribute" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.ProofAndOthers.Warning</validator>
				</validation>
				<validation id="4.5.15" description="Outer Carton Labels operation attribute (including all subnodes)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.ApprovedOCL</validator>
				</validation>
				<validation id="4.5.16" description="Inner/Blister Labels operation attribute (including all subnodes)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.InnerBlisterLabels</validator>
				</validation>
				<validation id="4.5.17" description="Package Insert operation attribute (including all subnodes)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.PackageInsert</validator>
				</validation>
				<validation id="4.5.18" description="Patient Information Leaflet operation attribute (including all subnodes)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.PatientInformationLeaflet</validator>
				</validation>
				<validation id="4.5.19" description="Approved Foreign Labelling operation attribute (including all subnodes)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.ApprovedForeignLabelling</validator>
				</validation>
				<validation id="4.5.20" description="Singapore-Specific Annex operation attribute" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.SingaporeSpecificAnnex</validator>
				</validation>
				<validation id="4.5.21" description="Reference RMP operation attribute" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.ReferenceRMP</validator>
				</validation>
				<validation id="4.5.22" description="Educational/RMP Materials operation attribute (including all subnodes)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-5">Operation.InvalidNewOperation.EducationalRMPMaterials</validator>
				</validation>
			</validation>
			<validation id="4.6" description="4.6 File Existence">
				<validation id="4.6.1" description="1.0.1 Cover Letter must exist" severity="Error">
					<validator type="log" dependingOption="sg-10-4-6">File.CoverLetter.NotFound</validator>
				</validation>
				<validation id="4.6.2" description="1.0.4 Response to Input Request must exist if the Sequence Type is 'Response'" severity="Error">
					<validator type="log" dependingOption="sg-10-4-6">ResponseDocForResponseType</validator>
				</validation>
				<validation id="4.6.3" description="Provide Source Files in section 1.2.2" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-6">FileExtension.NotAllow</validator>
				</validation>
				<validation id="4.6.4" description="Provide New Source Files" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-6">PdfSourceOperationMismatchError.New</validator>
				</validation>
				<validation id="4.6.5" description="Provide Replaced Source Files" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-6">PdfSourceOperationMismatchError.Replace</validator>
				</validation>
				<validation id="4.6.6" description="Delete File where Source Files are required" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-6">PdfSourceOperationMismatchError.Delete</validator>
				</validation>
				<validation id="4.6.7" description="Only Module 1 content allowed in Closing Information sequences." severity="Error">
					<validator type="log" dependingOption="sg-10-4-6">IndexContent.NotAllow</validator>
				</validation>
				<validation id="4.6.8" description="No Module 3 content allowed for Submission Type MAV2" severity="Error">
					<validator type="log" dependingOption="sg-10-4-6">Module3Content.NotAllow</validator>
				</validation>
				<validation id="4.6.9" description="Provide at most ONE document per sequence per the SG-HSA M1 Granularity Annex" severity="Error">
					<validator type="log" dependingOption="sg-10-4-6">MultipleFilesInSectionError</validator>
				</validation>
			</validation>
			<validation id="4.7" description="4.7 - Envelope">
				<validation id="4.7.1a" description="Envelope: application" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.Application</validator>
				</validation>
				<validation id="4.7.1b" description="Envelope: application (Attribute Code Validity)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ApplicationCodeVersion</validator>
				</validation>
				<validation id="4.7.2a" description="Envelope: application-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.AppNumber</validator>
				</validation>
				<validation id="4.7.2b" description="Envelope: application-number (match submission-number)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">AppNumber.NotCorrespond</validator>
				</validation>
				<validation id="4.7.3" description="Envelope: sg-ectd-id" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.EctdID.Invalid</validator>
				</validation>
				<validation id="4.7.4" description="Envelope: sg-ectd-id must be identical to the Application Folder name" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">EctdID.NotAllow</validator>
				</validation>
				<validation id="4.7.5" description="Envelope: inn" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.Inn</validator>
				</validation>
				<validation id="4.7.6a" description="Envelope: product-type" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ProductType.Invalid</validator>
				</validation>
				<validation id="4.7.6b" description="Envelope: product-type (Attribute Code Validity)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ProductType.InvalidCode</validator>
				</validation>
				<validation id="4.7.6c" description="Envelope: product-type DMF (Appropriate Submission Types)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SubmissionType.ProductDMF</validator>
				</validation>
				<validation id="4.7.7a" description="Envelope: dmf-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.DuplicateDMFNum</validator>
				</validation>
				<validation id="4.7.7b" description="Envelope: dmf-number provided when DMF content included" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.DMFNumIsRequire</validator>
				</validation>
				<validation id="4.7.8a" description="Envelope: pmf-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.PmfNumber</validator>
				</validation>
				<validation id="4.7.8b" description="Envelope: pmf-number provided when PMF content included" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.PmfNumberSection</validator>
				</validation>
				<validation id="4.7.9" description="Envelope: proprietary-name" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ProprietaryName.Invalid</validator>
				</validation>
				<validation id="4.7.10" description="Envelope: sin-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.DuplicateSINNum</validator>
				</validation>
				<validation id="4.7.11a" description="Envelope: submission" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.Submission</validator>
				</validation>
				<validation id="4.7.11b" description="Envelope: submission (Attribute Code Validity)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SubmissionCodeVersion</validator>
				</validation>
				<validation id="4.7.11c" description="Envelope: submission (Submission Combination Validity)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SubmissionCombine</validator>
				</validation>
				<validation id="4.7.11d" description="Envelope: submission (Multiple Submissions in eCTD)" severity="Information">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.MultipleSubmissionInfo</validator>
				</validation>
				<validation id="4.7.11e" description="Envelope: submission DMF (Appropriate Product Type)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ProductType.SubmissionDMF</validator>
				</validation>
				<validation id="4.7.12" description="Envelope: submission-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SubmissionNumber.Invalid</validator>
				</validation>
				<validation id="4.7.13a" description="Envelope: sequence" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.Sequence.Invalid</validator>
				</validation>
				<validation id="4.7.13b" description="Envelope: sequence (Attribute Code Validity)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SequenceType.InvalidCode</validator>
				</validation>
				<validation id="4.7.14" description="Envelope: sequence-description" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SequenceDes.Invalid</validator>
				</validation>
				<validation id="4.7.15a" description="Envelope: sequence-date" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SequenceDate.Invalid</validator>
				</validation>
				<validation id="4.7.15b" description="Envelope: sequence-date (Not outdated)" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.SequenceDate.OverLimit</validator>
				</validation>
				<validation id="4.7.16a" description="Envelope: sequence-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">UniqueSequenceNumber</validator>
        </validation>
				<validation id="4.7.16b" description="Sequence folder name must match Sequence Number from envelope" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">SequenceNumberNotMatch</validator>
				</validation>
				<validation id="4.7.17a" description="Envelope: related-sequence-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">UniqueRelatedSequenceNumber</validator>
				</validation>
				<validation id="4.7.17b" description="Element related-sequence-number value" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">RelatedSequenceNumber.Lower</validator>
				</validation>
				<validation id="4.7.17c" description="Sequence Type 'Initial' references itself as related-sequence-number" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">RelatedSequenceReferItSelf</validator>
				</validation>
				<validation id="4.7.18a" description="Envelope: contact" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.Contact.Invalid</validator>
				</validation>
				<validation id="4.7.18b" description="Envelope: contact (Attribute Code Validity)" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.Contact.InvalidCode</validator>
				</validation>
				<validation id="4.7.19" description="Envelope: contact-name" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ContactName.Invalid</validator>
				</validation>
				<validation id="4.7.20" description="Envelope: contact-email" severity="Error">
					<validator type="log" dependingOption="sg-10-4-7">Envelope.ContactEmail.Invalid</validator>
				</validation>
			</validation>
			<validation id="4.8" description="4.8 - Content">
				<validation id="4.8.1" description="Required documents and prohibited documents" severity="Error">
					<validator type="log" dependingOption="sg-10-4-8">RequiredFile.NotExist</validator>
          <validator type="log" dependingOption="sg-10-4-8">ExcludedFile.Exist</validator>
        </validation>
				<validation id="4.8.2" description="Expected documents and documents that should not be provided" severity="Warning">
					<validator type="log" dependingOption="sg-10-4-8">ExpectedFile.NotExist</validator>
          <validator type="log" dependingOption="sg-10-4-8">ExcludedFile.Exist.Warning</validator>
        </validation>
				<validation id="4.8.3" description="Possible documents" severity="Information">
					<validator type="log" dependingOption="sg-10-4-8">PossibleFile.NotExist</validator>
				</validation>
			</validation>
		</validation>
		<validation id="5" description="5 - STF">
			<validation id="5.1" description="5.1 References">
				<validation id="5.1.1" description="Check index reference" severity="Error">
					<validator type="log" dependingOption="sg-10-5-1">Stf.LeafId.NotExist</validator>
				</validation>
				<validation id="5.1.2" description="No backslash in xlink:href reference" severity="Error">
					<validator type="log" dependingOption="sg-10-5-1">StfHrefHasBackslashes</validator>
				</validation>
				<validation id="5.1.3" description="STF leaf elements must reference other STF leaf upon append" severity="Error">
					<validator type="log" dependingOption="sg-10-5-1">Stf.Append.ReferenceOtherStf</validator>
				</validation>
				<validation id="5.1.4" description="STF cannot reference another STF" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-1">Stf.ReferenceStf</validator>
				</validation>
				<validation id="5.1.5" description="STF files must reference at least one leaf" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-1">Stf.NotHasReferencedLeaf</validator>
				</validation>
				<validation id="5.1.6" description="Cumulative STF files are not allowed" severity="Error">
					<validator type="log" dependingOption="sg-10-5-1">Stf.Cumulative</validator>
				</validation>
			</validation>
			<validation id="5.2" description="5.2 Heading Elements, Leaves and Node Extensions">
				<validation id="5.2.1" description="Content Blocks are not accepted" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.ContentBlock.NotAccepted</validator>
				</validation>
				<validation id="5.2.2" description="Study Identifier category must not be empty" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.Categories.Empty</validator>
				</validation>
				<validation id="5.2.3" description="Study Identifier study-id must not be empty" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.StudyId.Empty</validator>
				</validation>
				<validation id="5.2.4" description="Study Identifier title must not be empty" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.Title.Empty</validator>
				</validation>
				<validation id="5.2.5" description="Categories and file tags" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.Category.NotSupported</validator>
					<validator type="log" dependingOption="sg-10-5-2">Stf.FileTag.NotSupported</validator>
					<validator type="log" dependingOption="sg-10-5-2">Stf.Property.NotSupported</validator>
				</validation>
				<validation id="5.2.6" description="Category information must be provided for certain STFs" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.Category.Missing</validator>
				</validation>
				<validation id="5.2.7" description="Invalid STF TOC location" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.WrongSection</validator>
				</validation>
				<validation id="5.2.8" description="STF doc-content file tag count" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-2">Stf.FileTag.NotExist1</validator>
				</validation>
			</validation>
			<validation id="5.3" description="5.3 Life Cycle Management">
				<validation id="5.3.1" description="Study ID for STF must remain constant" severity="Warning">
					<validator type="log" dependingOption="sg-10-5-3">Stf.StudyId.NotMatch</validator>
				</validation>
			</validation>
			<validation id="5.4" description="5.4 STF Information">
				<validation id="5.4.1" description="Informational output about the number and total size of non E3 documents." severity="Information">
					<validator type="log" dependingOption="sg-10-5-4">Stf.E3Info</validator>
				</validation>
			</validation>
		</validation>
		<validation id="6" description="6 - PDF Analysis">
			<validation id="6.1" description="6.1 PDF Readability">
				<validation id="6.1.1" description="PDF documents must be readable" severity="Error">
					<validator type="log" dependingOption="sg-10-6-1">Pdf.Failed</validator>
				</validation>
			</validation>
			<validation id="6.2" description="6.2 Bookmarks">
				<validation id="6.2.1" description="Bookmarks must be relative" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">AbsolutePathBookmarkInPdf</validator>
				</validation>
				<validation id="6.2.2" description="Bookmarks with web or email destinations" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">ExternalBookmark</validator>
				</validation>
				<validation id="6.2.3" description="Bookmarks with destinations outside repository root folder are not allowed" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">PdfExternalDestinationBookmark</validator>
				</validation>
				<validation id="6.2.4" description="Bookmarks must not have multiple actions" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">PdfMultipleActionBookmark</validator>
				</validation>
				<validation id="6.2.5" description="Bookmarks must not be inactive" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">PdfInactiveBookmark</validator>
				</validation>
				<validation id="6.2.6" description="Bookmarks must not be broken" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">BookmarkBrokenLinkInPdf</validator>
				</validation>
				<validation id="6.2.7" description="Bookmarks must be 'Inherit Zoom'" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">Bookmark.Pdf.InvalidMagnification</validator>
				</validation>
				<validation id="6.2.8" description="Bookmarks should exist in all larger documents" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-2">Consistent.PageAndBookmark</validator>
				</validation>
			</validation>
			<validation id="6.3" description="6.3 Hyperlinks">
				<validation id="6.3.1" description="Hyperlinks must be relative" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-3">AbsolutePathInPdf</validator>
				</validation>
				<validation id="6.3.2" description="Hyperlinks with destinations outside repository root folder are not allowed" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-3">PdfExternalDestinationHyperLink</validator>
				</validation>
				<validation id="6.3.3" description="Hyperlinks must not have multiple actions" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-3">PdfMultipleAction</validator>
				</validation>
				<validation id="6.3.4" description="Hyperlinks must not be inactive" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-3">PdfInactiveBookmarkHyperlink</validator>
				</validation>
				<validation id="6.3.5" description="Hyperlinks must not be broken" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-3">BrokenLinkInPdf</validator>
				</validation>
				<validation id="6.3.6" description="Hyperlinks must 'Inherit Zoom'" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-3">Pdf.InvalidMagnification</validator>
				</validation>
				<validation id="6.3.7" description="Hyperlinks must exist in Response documents" severity="Information">
					<validator type="log" dependingOption="sg-10-6-3">LinkToRelevantDocument</validator>
				</validation>
				<validation id="6.3.8" description="Hyperlinks with web or email destinations" severity="Information">
					<validator type="log" dependingOption="sg-10-6-3">Pdf.UseURLLink</validator>
				</validation>
			</validation>
			<validation id="6.4" description="6.4 PDF Properties">
				<validation id="6.4.1" description="PDF documents should not have security settings which prevent copying or printing" severity="Error">
					<validator type="log" dependingOption="sg-10-6-4">PdfOwnerPassword</validator>
				</validation>
				<validation id="6.4.2" description="PDF documents must not be password protected to open" severity="Error">
					<validator type="log" dependingOption="sg-10-6-4">PdfSecurity</validator>
				</validation>
				<validation id="6.4.3" description="PDF version must be correct" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-4">Pdf.UnsupportedPdfVersion</validator>
				</validation>
				<validation id="6.4.4" description="PDF documents with attachments are not allowed" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-4">PdfAttachmentDetected</validator>
				</validation>
				<validation id="6.4.5" description="PDF initial view must be correct" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-4">Pdf.InvalidInitialView.Bookmark</validator>
					<validator type="log" dependingOption="sg-10-6-4">InvalidPageModeWhenNoBookmark</validator>
					<validator type="log" dependingOption="sg-10-6-4">Pdf.InvalidInitialView</validator>
				</validation>
				<validation id="6.4.6" description="PDF should have 'Fast Web Access' active" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-4">PdfFastWebAccess</validator>
				</validation>
				<validation id="6.4.7" description="PDF documents with annotations" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-4">PdfAnnotations</validator>
				</validation>
			</validation>
			<validation id="6.5" 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="sg-10-6-5">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="sg-10-6-5">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="sg-10-6-5">Index.Checksum.InvalidFormat</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="sg-10-6-5">LeafId.Invalid</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="sg-10-6-5">References.AcrossApplication</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="sg-10-6-5">SameSequenceNumber</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="sg-10-6-5">ModifiedFile.IncorrectSyntax</validator>
				</validation>
        <validation id="Recommended" description="For 'new' Operation, 'modified-file' Attribute Is Not Present" severity="Warning">
          <validator type="log" dependingOption="sg-10-6-5">ModifiedFileExist</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="sg-10-6-5">ValidationFailed</validator>
					<validator type="log" dependingOption="sg-10-6-5">SubmissionChecksum.Failed</validator>
				</validation>
				<validation id="Recommended" description="The system shall ensure that index MD5 txt file is named correctly (i.e. index-md5.txt)" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">SubmissionChecksumFileName.Failed</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="sg-10-6-5">AccessibleFileFolder</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="sg-10-6-5">PdfBackslash</validator>
					<validator type="log" dependingOption="sg-10-6-5">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="sg-10-6-5">RefOutsideSeqOrApp</validator>
					<validator type="log" dependingOption="sg-10-6-5">RefOutsideSeqOrAppBookmark</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="sg-10-6-5">PdfUnknownAction</validator>
					<validator type="log" dependingOption="sg-10-6-5">PdfUnknownActionBookmark</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="sg-10-6-5">PdfTotalNonRelativeBookmarks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalWebEmailDestinationBookmarks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalExternalDestinationBookmarks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalUnknownActionBookmarks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalInActiveBookmarks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalBrokenBookmarks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfNumberOfBookmarksPerDocument</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalBookmarksInSubmission</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalNonRelativeHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalWebEmailDestinationHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalExternalDestinationHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalUnknownActionHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalInActiveHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalBrokenHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">PdfTotalHyperLinks</validator>
          <validator type="log" dependingOption="sg-10-6-5">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="sg-10-6-5">RefDocCorrupted</validator>
					<validator type="log" dependingOption="sg-10-6-5">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="sg-10-6-5">BlankLinkInPdf</validator>
					<validator type="log" dependingOption="sg-10-6-5">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="sg-10-6-5">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="sg-10-6-5">Stf.TitleNotProvided</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="sg-10-6-5">Stf.NotExist</validator>
				</validation>
				<validation id="Recommended" description="Ensure that STF title (within study-identifier element) in the stf xml file matches with the leaf title for the stf in the index.xml file." severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">Stf.Title.NotMatch</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="sg-10-6-5">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="sg-10-6-5">InvalidStfFileExtension</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="sg-10-6-5">Stf.UnsupportedSchemaVersion</validator>
				</validation>
				<validation id="Recommended" description="Ensure that valid STF DTD version (e.g. version = &quot;STF Version 2.2&quot;) is listed in the index.xml file for stf leaf element" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">Stf.UnsupportedDtdVersion</validator>
				</validation>
				<validation id="Recommended" description="Ensure that STF DTD version in stf xml file (i.e. dtd-version = &quot;2.2&quot;) must match the stf dtd version specified for the stf leaf in index.xml file (i.e. version = &quot;STF Version 2.2&quot;)" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">Stf.DtdVersionNotMatch</validator>
				</validation>
				<validation id="Recommended" description="Ensure that STF DTD version (e.g. dtd-version = &quot;2.2&quot;) is specified in the STF XML file" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">Stf.MissingDtdAttribute</validator>
				</validation>
				<validation id="Recommended" description="Ensure that STF DTD version (e.g. version = &quot;STF Version 2.2&quot;) is specified in the index.xml file for stf leaf element" severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">Stf.MissingDtdVersion</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="sg-10-6-5">Leaf.Title.LeadsOrEndsWithSpace</validator>
					<validator type="log" dependingOption="sg-10-6-5">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="sg-10-6-5">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="sg-10-6-5">IchDtdVersion</validator>
					<validator type="log" dependingOption="sg-10-6-5">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="sg-10-6-5">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="sg-10-6-5">SpaceInAttribute</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="sg-10-6-5">InvalidLeafOperation</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="sg-10-6-5">InvalidLifeCyclePatternAppendOnAppend</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="sg-10-6-5">NoneLeafElement</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="sg-10-6-5">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="sg-10-6-5">RegionalBackboneReferenced.WrongOperationAttribute</validator>
				</validation>
				<validation id="Recommended" description="Ensure that 'm1' folder must exist in the submission. " severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">M1Folder.NotExist</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. This is applicable for Module 4 and Module 5." severity="Warning">
					<validator type="log" dependingOption="sg-10-6-5">Stf.FileName.Specific</validator>
				</validation>
			</validation>
		</validation>
	</validations>
</validationreport>