ws.xsd

<?xml version="1.0" encoding="UTF-8"?>
<schema xmlns="http://www.w3.org/2001/XMLSchema" targetNamespace="gov.nih.nci.pa.webservices.types"
	xmlns:tns="gov.nih.nci.pa.webservices.types" elementFormDefault="qualified"
	xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xjc="http://java.sun.com/xml/ns/jaxb/xjc"
	xmlns:jaxb="http://java.sun.com/xml/ns/jaxb" jaxb:version="2.1"
	xmlns:annox="http://annox.dev.java.net" xmlns:ja="http://annox.dev.java.net/org.codehaus.jackson.annotate"
	xmlns:po="gov.nih.nci.po.webservices.types.trimmed"
	xsi:schemaLocation="http://java.sun.com/xml/ns/jaxb http://java.sun.com/xml/ns/jaxb/bindingschema_2_0.xsd
	                    gov.nih.nci.po.webservices.types.trimmed po.xsd
                        http://www.w3.org/2001/XMLSchema http://www.w3.org/2001/XMLSchema.xsd">

	<annotation>
		<appinfo>
			<jaxb:schemaBindings>
				<jaxb:package name="gov.nih.nci.pa.webservices.types" />
			</jaxb:schemaBindings>
		</appinfo>
	</annotation>

	<import namespace="gov.nih.nci.po.webservices.types.trimmed"
		schemaLocation="po.xsd" />

	<element name="clinicalTrialsDotGovTrialID">
		<annotation>
			<documentation>The format for the ClinicalTrials.gov registry number
				is NCT followed by an 8-digit number, e.g.: NCT00000419.
			</documentation>
		</annotation>
		<simpleType>
			<restriction base="string">
				<pattern value="NCT[0-9]{1,47}" />
				<maxLength value="50" />
			</restriction>
		</simpleType>
	</element>

	<element name="TrialRegistrationConfirmation" type="tns:TrialRegistrationConfirmation">
		<annotation>
			<documentation>A snapshot of basic trial information that serves as a
				confirmation of a successful trial registration, update, or
				amendment.
			</documentation>
		</annotation>
	</element>

	<complexType name="TrialRegistrationConfirmation">
		<annotation>
			<documentation>A snapshot of basic trial information that serves as a
				confirmation of a successful trial registration, update, or
				amendment.
			</documentation>
		</annotation>
		<sequence>
			<element name="paTrialID" type="long">
				<annotation>
					<documentation>PA's internal trial identifier, which is a numerical
						value. Immutable.
					</documentation>
				</annotation>
			</element>
			<element name="nciTrialID">
				<annotation>
					<documentation>NCI ID assigned to each newly registered trial. It
						follows a specific format (e.g. NCI-2014-00672) and stays
						immutable
						with a trial.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<pattern value="NCI-[0-9]{4}-[0-9]{1,8}" />
					</restriction>
				</simpleType>
			</element>
		</sequence>
	</complexType>

	<simpleType name="TrialCategory">
		<annotation>
			<documentation>List of trial categories.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="National" />
			<enumeration value="Externally Peer-Reviewed" />
			<enumeration value="Institutional" />
		</restriction>
	</simpleType>

	<simpleType name="TrialPhase">
		<annotation>
			<documentation>List of trial phases.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="0" />
			<enumeration value="I" />
			<enumeration value="I/II" />
			<enumeration value="II" />
			<enumeration value="II/III" />
			<enumeration value="III" />
			<enumeration value="IV" />
			<enumeration value="NA" />
		</restriction>
	</simpleType>

	<simpleType name="PrimaryPurpose">
		<annotation>
			<documentation>List of trial primary purposes.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Treatment" />
			<enumeration value="Prevention" />
			<enumeration value="Supportive Care" />
			<enumeration value="Screening" />
			<enumeration value="Diagnostic" />
			<enumeration value="Health Services Research" />
			<enumeration value="Basic Science" />
			<enumeration value="Other" />
		</restriction>
	</simpleType>

	<simpleType name="SecondaryPurpose">
		<annotation>
			<documentation>List of trial secondary purposes.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Ancillary-Correlative" />
			<enumeration value="Other" />
		</restriction>
	</simpleType>

	<simpleType name="AccrualDiseaseTerminology">
		<annotation>
			<documentation>List of accrual disease terminologies.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="SDC" />
			<enumeration value="ICD10" />
			<enumeration value="ICD9" />
			<enumeration value="ICD-O-3" />
		</restriction>
	</simpleType>

	<simpleType name="NonInterventionalTrialType">
		<annotation>
			<documentation>Types of Non-Interventional Trials.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Observational" />
			<enumeration value="Ancillary-Correlative" />
		</restriction>
	</simpleType>

	<simpleType name="StudyModelCode">
		<annotation>
			<documentation>Study model codes.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Cohort" />
			<enumeration value="Case-control" />
			<enumeration value="Case-only" />
			<enumeration value="Case-crossover" />
			<enumeration value="Ecologic or community studies" />
			<enumeration value="Family-based" />
			<enumeration value="Other" />
		</restriction>
	</simpleType>

	<simpleType name="TimePerspectiveCode">
		<annotation>
			<documentation>Time perspective codes.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Prospective" />
			<enumeration value="Retrospective" />
			<enumeration value="Cross-sectional" />
			<enumeration value="Other" />
		</restriction>
	</simpleType>

	<simpleType name="ResponsiblePartyType">
		<annotation>
			<documentation>Responsible party type.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Sponsor" />
			<enumeration value="Principal Investigator" />
			<enumeration value="Sponsor-Investigator" />
		</restriction>
	</simpleType>

	<simpleType name="TrialStatusCode">
		<annotation>
			<documentation>Trial status codes.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="In Review" />
			<enumeration value="Approved" />
			<enumeration value="Active" />
			<enumeration value="Enrolling by Invitation" />
			<enumeration value="Closed to Accrual" />
			<enumeration value="Closed to Accrual and Intervention" />
			<enumeration value="Temporarily Closed to Accrual" />
			<enumeration value="Temporarily Closed to Accrual and Intervention" />
			<enumeration value="Withdrawn" />
			<enumeration value="Administratively Complete" />
			<enumeration value="Complete" />
		</restriction>
	</simpleType>

	<simpleType name="RecruitmentStatus">
		<annotation>
			<documentation>Participating site recruitment status codes.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="In Review" />
			<enumeration value="Approved" />
			<enumeration value="Active" />
			<enumeration value="Enrolling by Invitation" />
			<enumeration value="Closed to Accrual" />
			<enumeration value="Closed to Accrual and Intervention" />
			<enumeration value="Temporarily Closed to Accrual" />
			<enumeration value="Temporarily Closed to Accrual and Intervention" />
			<enumeration value="Withdrawn" />
			<enumeration value="Administratively Complete" />
			<enumeration value="Completed" />
		</restriction>
	</simpleType>

	<complexType name="ResponsibleParty">
		<annotation>
			<documentation>Provides a trial's responsible party details. Only
				applicable to trials that
				require uploads to ClinicalTrials.gov.
			</documentation>
		</annotation>
		<sequence>
			<element name="type" type="tns:ResponsiblePartyType">
				<annotation>
					<documentation>
						Type of Responsible Party of the trial. Please note
						that this value governs the use of the next three elements.
					</documentation>
				</annotation>
			</element>
			<element name="investigator" minOccurs="0" type="tns:Person">
				<annotation>
					<documentation>
						This element can be used when responsible party
						type
						is
						Sponsor-Investigator; use it to specify a
						Responsible Party
						Investigator, which can be different from the Trial
						Principal
						Investigator. If omitted, Responsible Party
						Investigator will
						default to the Trial
						Principal
						Investigator.

						For other responsible
						party types this
						element will be ignored and
						Responsible Party
						Investigator will ALWAYS
						default to the Trial
						Principal
						Investigator.
					</documentation>
				</annotation>
			</element>
			<element name="investigatorTitle" type="string" minOccurs="0">
				<annotation>
					<documentation>
						Title of the Responsible Party Investigator. This
						element is not applicable and thus should be omitted
						when
						responsible party
						type is Sponsor. Use it only when responsible
						party is either Principal Investigator or
						Sponsor-Investigator. If
						omitted, title will default to "Principal Investigator".
					</documentation>
				</annotation>
			</element>
			<element name="investigatorAffiliation" minOccurs="0"
				type="tns:Organization">
				<annotation>
					<documentation>
						An Organization that Responsible Party Investigator
						is affiliated
						with. Use this element
						only when responsible party
						type is Principal Investigator. If omitted, affiliation will
						default to Trial Sponsor organization.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>

	<complexType name="OrganizationOrPersonID">
		<annotation>
			<documentation>
				Every Organization or Person in CTRP normally can be
				uniquely identified
				by either a numeric PO ID (preferred)
				or a CTEP
				ID. In most cases when you need to refer to an existing Organization
				or Person, you can use either type of identifier.
			</documentation>
		</annotation>
		<choice>
			<element name="poID" type="long" />
			<element name="ctepID">
				<simpleType>
					<restriction base="string">
						<minLength value="1" />
					</restriction>
				</simpleType>
			</element>
		</choice>
	</complexType>

	<complexType name="Organization">
		<annotation>
			<documentation>Represents information about an Organization that
				plays a role (Lead Organization, Sponsor, etc) on a
				trial. Every
				organization ultimately must exist in NCI PO (Curation) Tool before using this service. If it
				does not,
				it has to be created in PO before a trial can be
				registered. If you know PO ID or CTEP ID of an organization that
				already exists, please use that. It is required that you exercise NCI PO Web
				Services separately to search for the organization you need
				and
				obtain a PO ID prior to invoking CTRP Trial Registration or
				Participating Site services. 
			</documentation>
		</annotation>
		<sequence>
			<choice>
				<element name="existingOrganization" type="tns:OrganizationOrPersonID" />				
				<element name="newOrganization" type="po:Organization">
				    <annotation>
				        <documentation>
				        DO NOT use this element. Organization must exist prior to invoking the service. See above for explanation.
				        </documentation>
				    </annotation>
				</element>
			</choice>
		</sequence>
	</complexType>

	<complexType name="Person">
		<annotation>
			<documentation>Represents information about a Person that
				plays a role
				(Principal Investigator, etc) on a
				trial. Every
				Person ultimately must
				exist in NCI PO (Curation) Tool. If it
				does not,
				it has to be created
				in PO before a trial can be
				registered. If you know PO ID or CTEP ID
				of a Person that
				already exists, please use that in order
				to avoid
				creation of
				duplicates. It is required that you exercise
				NCI PO Web
				Services separately to search for the Person you need
				and
				obtain a PO ID prior to invoking CTRP Trial Registration or
				Participating Site services. 
			</documentation>
		</annotation>
		<sequence>
			<choice>
				<element name="existingPerson" type="tns:OrganizationOrPersonID" />
				<element name="newPerson" type="po:Person">
				    <annotation>
                        <documentation>
                        DO NOT use this element. Person must exist prior to invoking the service. See above for explanation.
                        </documentation>
                    </annotation>
				</element>
			</choice>
		</sequence>
	</complexType>

	<simpleType name="OtherDescription">
		<annotation>
			<documentation>Whenever a trial attribute, such as Primary Purpose,
				is set to 'Other', often an additional description is required. This
				XML type defines such a description.
			</documentation>
		</annotation>
		<restriction base="string">
			<maxLength value="200" />
			<minLength value="1" />
		</restriction>
	</simpleType>

	<complexType name="TrialDateType">
		<annotation>
			<documentation>Defines a type of a trial date that is either actual
				or anticipated. 'N/A' is only applicable to Primary Completion Date
				and only on DCP trials.
			</documentation>
		</annotation>
		<simpleContent>
			<extension base="date">
				<attribute name="type" use="required">
					<simpleType>
						<restriction base="string">
							<enumeration value="Actual" />
							<enumeration value="Anticipated" />
							<enumeration value="N/A" />
						</restriction>
					</simpleType>
				</attribute>
			</extension>
		</simpleContent>
	</complexType>

	<complexType name="TrialDocument">
		<annotation>
			<documentation>A Trial Document. CTRP accepts most standard document
				types. For additional information about what document types are
				accepted, please refer to the Help section.
			</documentation>
		</annotation>
		<simpleContent>
			<extension base="base64Binary">
				<attribute name="filename" use="required" type="string" />
			</extension>
		</simpleContent>
	</complexType>


	<complexType name="InterventionalTrialDesign">
		<annotation>
			<documentation>Design details of an Interventional trial.
			</documentation>
		</annotation>
		<sequence>
			<element name="secondaryPurpose" type="tns:SecondaryPurpose"
				minOccurs="0" />
			<element name="secondaryPurposeOtherDescription" type="tns:OtherDescription"
				minOccurs="0">
				<annotation>
					<documentation>If Trial Secondary Purpose is 'Other', please
						provide
						an additional description of the trial's purpose using this
						element.
					</documentation>
				</annotation>
			</element>

		</sequence>
	</complexType>

	<simpleType name="HolderType">
		<annotation>
			<documentation>Type of IND/IDE holder.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Investigator" />
			<enumeration value="Organization" />
			<enumeration value="Industry" />
			<enumeration value="NIH" />
			<enumeration value="NCI" />
		</restriction>
	</simpleType>

	<simpleType name="GrantorCode">
		<annotation>
			<documentation>Organization that holds the IND/IDE
				approval.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="CDER" />
			<enumeration value="CBER" />
			<enumeration value="CDRH" />
		</restriction>
	</simpleType>

	<simpleType name="NihInstitutionCode">
		<annotation>
			<documentation>NIH Institutions Codes
			</documentation>
		</annotation>
		<restriction base="string">
			<!-- * National Eye Institute. -->
			<enumeration value="NEI" />
			<!-- National Heart, Lung, and Blood Institute. -->
			<enumeration value="NHLBI" />
			<!-- National Human Genome Research Institute. -->
			<enumeration value="NHGRI" />
			<!-- National Institute on Aging. -->
			<enumeration value="NIA" />
			<!-- National Institute on Alcohol Abuse and Alcoholism. -->
			<enumeration value="NIAAA" />
			<!-- National Institute of Allergy and Infectious Diseases. -->
			<enumeration value="NIAID" />
			<!-- National Institute of Arthritis and Musculoskeletal and Skin Diseases. -->
			<enumeration value="NIAMS" />
			<!-- National Institute of Biomedical Imaging and Bioengineering. -->
			<enumeration value="NIBIB" />
			<!-- Eunice Kennedy Shriver National Institute of Child Health and Human 
				Development. -->
			<enumeration value="NICHD" />
			<!-- <enumeration value="National Institute on Deafness and Other Communication 
				Disorders. -->
			<enumeration value="NIDCD" />
			<!-- National Institute of Dental and Craniofacial Research. -->
			<enumeration value="NIDCR" />
			<!-- National Institute of Diabetes and Digestive and Kidney Diseases. -->
			<enumeration value="NIDDK" />
			<!-- National Institute on Drug Abuse. -->
			<enumeration value="NIDA" />
			<!-- National Institute of Environmental Health Sciences. -->
			<enumeration value="NIEHS" />
			<!-- National Institute of General Medical Sciences. -->
			<enumeration value="NIGMS" />
			<!-- National Institute of Mental Health. -->
			<enumeration value="NIMH" />
			<!-- National Institute of Neurological Disorders and Stroke. -->
			<enumeration value="NINDS" />
			<!-- National Institute of Nursing Research. -->
			<enumeration value="NINR" />
			<!-- National Library of Medicine. -->
			<enumeration value="NLM" />
			<!-- Center for Information Technology. -->
			<enumeration value="CIT" />
			<!-- Center for Scientific Review. -->
			<enumeration value="CSR" />
			<!-- John E. Fogarty International Center for Advanced Study in the Health 
				Sciences. -->
			<enumeration value="FIC" />
			<!-- National Center for Complementary and Alternative Medicine. -->
			<enumeration value="NCCAM" />
			<!-- National Center on Minority Health and Health Disparities. -->
			<enumeration value="NCMHD" />
			<!-- National Center for Research Resources (NCRR). -->
			<enumeration value="NCRR" />
			<!-- NIH Clinical Center. -->
			<enumeration value="CC" />
			<!-- Office of the Director. -->
			<enumeration value="OD" />

		</restriction>
	</simpleType>

	<simpleType name="NciDivisionProgramCode">
		<annotation>
			<documentation>NCI Division Program Codes.
			</documentation>
		</annotation>
		<restriction base="string">
			<!-- CCR-Center for Cancer Research. -->
			<enumeration value="CCR" />
			<!-- Center for Cancer Training / Cancer Training Branch. -->
			<enumeration value="CCT/CTB" />
			<!-- CIP-Cancer Imaging Program. -->
			<enumeration value="CIP" />
			<!-- CDP-Cancer Diagnosis Program. -->
			<enumeration value="CDP" />
			<!-- CTEP-Cancer Therapy Evaluation Program. -->
			<enumeration value="CTEP" />
			<!-- DCB-Division of Cancer Biology. -->
			<enumeration value="DCB" />
			<!-- DCCPS-Division of Cancer Control and Population Sciences. -->
			<enumeration value="DCCPS" />
			<!-- DCEG-Division of Cancer Epidemiology and Genetics. -->
			<enumeration value="DCEG" />
			<!-- DCP-Division of Cancer Prevention. -->
			<enumeration value="DCP" />
			<!-- DEA-Division of Extramural Activities. -->
			<enumeration value="DEA" />
			<!-- DTP-Developmental Therapeutics Program. -->
			<enumeration value="DTP" />
			<!-- OD-Office of the Director, NCI, NIH. -->
			<enumeration value="OD" />
			<!-- OSB/SPOREs -Organ Systems Branch (OSB) /Specialized Programs of Research 
				Excellence (SPOREs). -->
			<enumeration value="OSB/SPOREs" />
			<!-- TRP-Translational Research Program. -->
			<enumeration value="TRP" />
			<!-- RRP-Radiation Research Program. -->
			<enumeration value="RRP" />
			<!--* . -->
			<enumeration value="N/A" />
		</restriction>
	</simpleType>

	<simpleType name="ExpandedAccessType">
		<annotation>
			<documentation>If the study includes expanded access, select the
				access type indicating availability of an experimental drug or
				device outside any clinical trial protocol.
			</documentation>
		</annotation>
		<restriction base="string">
			<enumeration value="Available" />
			<enumeration value="No longer available" />
			<enumeration value="Temporarily not available" />
			<enumeration value="Approved for marketing" />
		</restriction>
	</simpleType>

	<complexType name="IND_IDE">
		<annotation>
			<documentation>Captures information about an Investigational New Drug
				(IND)
				application or an Investigational
				Device Exemption (IDE) used on
				the trial.
			</documentation>
		</annotation>
		<sequence>
			<element name="number" type="string">
				<annotation>
					<documentation>Enter the number assigned to an Investigational New
						Drug Application (IND) or Investigational Device Exemption (IDE).
						You can enter the IND number in many formats. For example, for a
						biologics (BB) IND that contains the number 1234, you can type
						BB1234, 1234, or BB_1234.
					</documentation>
				</annotation>
			</element>
			<element name="grantor" type="tns:GrantorCode">
				<annotation>
					<documentation>Select the organization that holds the IND/IDE
						approval. Typically, CDER or CBER.
					</documentation>
				</annotation>
			</element>
			<element name="holderType" type="tns:HolderType">
				<annotation>
					<documentation>Select the type of IND/IDE holder.
					</documentation>
				</annotation>
			</element>
			<element name="nihInstitution" type="tns:NihInstitutionCode"
				minOccurs="0">
				<annotation>
					<documentation>If the holder type is NIH, select the NIH
						Institution.
					</documentation>
				</annotation>
			</element>
			<element name="nciDivisionProgramCode" type="tns:NciDivisionProgramCode"
				minOccurs="0">
				<annotation>
					<documentation>If the holder type is NCI, select the NCI
						Division
						Program Code.
					</documentation>
				</annotation>
			</element>
			<element name="expandedAccess" type="boolean">
				<annotation>
					<documentation>Indicates whether or not an experimental drug or
						device is available outside any clinical trial protocol.
					</documentation>
				</annotation>
			</element>
			<element name="expandedAccessType" type="tns:ExpandedAccessType"
				minOccurs="0">
				<annotation>
					<documentation>If the study includes expanded access, select the
						access type indicating availability of an experimental drug or
						device outside any clinical trial protocol.
					</documentation>
				</annotation>
			</element>
			<element name="exempt" type="boolean">
				<annotation>
					<documentation>Indicates whether or not the trial is associated
						with the U.S.
						FDA and does not require IRB approval.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>

	<complexType name="Grant">
		<annotation>
			<documentation>Captures information about a grant that a trial is
				funded with.
			</documentation>
		</annotation>
		<sequence>
			<element name="fundingMechanism">
				<annotation>
					<documentation>Select the NIH funding mechanism unique identifier,
						a 3-character code used to identify areas of extramural research
						activity applied to funding mechanisms.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<pattern value="[A-Z0-9]{3}" />
					</restriction>
				</simpleType>
			</element>
			<element name="nihInstitutionCode">
				<annotation>
					<documentation>Select the two-letter code identifying the first
						major-level subdivision, the organization that supports an NIH
						grant, contract, or inter-agency agreement. The support may be
						financial or administrative.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<pattern value="[A-Z]{2}" />
					</restriction>
				</simpleType>
			</element>
			<element name="serialNumber">
				<annotation>
					<documentation>Enter the number generally assigned sequentially to
						a series within an Institute, Center, or Division.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<pattern value="[0-9]{1,200}" />
					</restriction>
				</simpleType>
			</element>
			<element name="nciDivisionProgramCode" type="tns:NciDivisionProgramCode">
				<annotation>
					<documentation>Select the NCI organizational unit that provides
						funding for the study.
					</documentation>
				</annotation>
			</element>
			<element name="fundingPercentage" minOccurs="0" type="float" />
		</sequence>
	</complexType>

	<complexType name="NonInterventionalTrialDesign">
		<annotation>
			<documentation>Design details of a Non-Interventional trial.
			</documentation>
		</annotation>
		<sequence>
			<element name="trialType" type="tns:NonInterventionalTrialType" />
			<element name="studyModelCode" type="tns:StudyModelCode" />
			<element name="studyModelCodeOtherDescription" type="tns:OtherDescription" minOccurs="0">
				<annotation>
					<documentation>If Trial Study Model Code is 'Other', please provide
						an additional description using this
						element.
					</documentation>
				</annotation>
			</element>
			<element name="timePerspectiveCode" type="tns:TimePerspectiveCode" />
			<element name="timePerspectiveCodeOtherDescription" type="tns:OtherDescription" minOccurs="0">
				<annotation>
					<documentation>If Time Perspective Code is 'Other', please provide
						an additional description using this
						element.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>

	<complexType name="RegulatoryInformation">
		<annotation>
			<documentation>Trial Regulatory Information. Required only for trials
				that require uploads into ClinicalTrials.gov.
			</documentation>
		</annotation>
		<sequence>
			<element name="country" type="po:CountryISO-3166-1-alpha-3-Code">
				<annotation>
					<documentation>Specify the country in which the Trial Oversight
						Authority is located. Use country's 3-digit ISO code.
					</documentation>
				</annotation>
			</element>
			<element name="authorityName" type="string">
				<annotation>
					<documentation>Select the name of each national or international
						health organization with authority over the protocol. Authority
						name must be known to CTRP. The list of authorities known by CTRP
						is quite large and volatile;
						please contact CTRP Analysts or CTRO
						Office for details. Failure to find a match in CTRP by name will
						cause the entire trial registration to fail.
					</documentation>
				</annotation>
			</element>
			<element name="fdaRegulated" type="boolean">
				<annotation>
					<documentation>Indicate whether this trial includes an intervention
						subject to US Food and Drug Administration regulation under
						section 351 of the Public Health Service Act or any of the
						following sections of the Federal Food, Drug and Cosmetic Act:
						505, 510(k), 515, 52.
					</documentation>
				</annotation>
			</element>
			<element name="section801" type="boolean">
				<annotation>
					<documentation>Indicate whether this is an 'applicable clinical
						trial' as defined in US Public Law 110-85, Title VIII, Section
						801.
					</documentation>
				</annotation>
			</element>
			<element name="delayedPosting" type="boolean">
				<annotation>
					<documentation>Indicate whether this trial includes a device NOT
						previously approved or cleared by the US FDA for any use, as
						specified in US Public Law 110-85, Title VIII, Section 801.
					</documentation>
				</annotation>
			</element>
			<element name="dataMonitoringCommitteeAppointed" type="boolean">
				<annotation>
					<documentation>Indicate whether a data monitoring committee has
						been appointed for this study.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>

	<element name="CompleteTrialRegistration" type="tns:CompleteTrialRegistration">
		<annotation>
			<documentation>A request to register a Complete trial in CTRP.
			</documentation>
		</annotation>
	</element>

	<element name="CompleteTrialAmendment" type="tns:CompleteTrialAmendment">
		<annotation>
			<documentation>A request to amend a Complete trial in CTRP.
			</documentation>
		</annotation>
	</element>

	<element name="CompleteTrialUpdate" type="tns:CompleteTrialUpdate">
		<annotation>
			<documentation>A request to update a Complete trial in CTRP. An
				update permits trial owners to change a limited set
				of data element
				of the trial. Most of the elements are optional; if you omit an
				element, corresponding trial data will remain unchanged.
			</documentation>
		</annotation>
	</element>

	<element name="AbbreviatedTrialUpdate" type="tns:AbbreviatedTrialUpdate">
		<annotation>
			<documentation>A request to update an Abbreviated trial in CTRP. An
				update permits trial owners to change a very limited set
				of data
				element
				of an Abbreviated trial. Most of the elements are optional;
				if you
				omit an
				element, corresponding trial data will remain
				unchanged.
			</documentation>
		</annotation>
	</element>

	<element name="ParticipatingSiteUpdate" type="tns:ParticipatingSiteUpdate">
		<annotation>
			<documentation>Represents an update to a participating site. Since an
				update to a site cannot change the organization, this type excludes
				the organization element.
			</documentation>
		</annotation>
	</element>

	<element name="ParticipatingSite" type="tns:ParticipatingSite">
		<annotation>
			<documentation>Represents a new or existing participating site on a
				trial: this
				includes organization information.
			</documentation>
		</annotation>
	</element>

	<element name="sites">
		<annotation>
			<documentation>List of participating sites.
			</documentation>
		</annotation>
		<complexType>
			<sequence>
				<element name="site" type="tns:ParticipatingSite" minOccurs="0"
					maxOccurs="unbounded" />
			</sequence>
		</complexType>
	</element>

	<complexType name="AbbreviatedTrialUpdate" final="#all"
		block="#all">
		<annotation>
			<documentation>A request to update an Abbreviated trial in CTRP. An
				update permits trial owners to change a very limited set
				of data
				element
				of an Abbreviated trial. Most of the elements are optional;
				if you
				omit an
				element, corresponding trial data will remain
				unchanged.
			</documentation>
		</annotation>
		<sequence>
			<element ref="tns:clinicalTrialsDotGovTrialID" minOccurs="0">
				<annotation>
					<documentation>
						If the trial does not currently specify a
						ClinicalTrials.Gov ID
						(a.k.a NCT ID), you can provide one during
						the update.
						If the trial does have a ClinicalTrials.Gov ID already,
						your update
						will not be allowed to change it; an attempt to do so
						will be ignored by CTRP.
					</documentation>
				</annotation>
			</element>
			<element name="irbApprovalDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>To ensure successful registration, upload a IRB
						Approval document
						document.
					</documentation>
				</annotation>
			</element>
			<element name="informedConsentDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>If the Protocol document does not include the
						Informed Consent and/or participating sites, upload the Informed
						Consent document.
					</documentation>
				</annotation>
			</element>
			<element name="otherDocument" type="tns:TrialDocument"
				minOccurs="0" maxOccurs="unbounded">
				<annotation>
					<documentation>Any other trial-related document.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>


	<complexType name="CompleteTrialUpdate" final="#all" block="#all">
		<annotation>
			<documentation>A request to update a Complete trial in CTRP. An
				update permits trial owners to change a limited set
				of data element
				of the trial. Most of the elements are optional; if you omit an
				element, corresponding trial data will remain unchanged.
			</documentation>
		</annotation>
		<sequence>
			<element ref="tns:clinicalTrialsDotGovTrialID" minOccurs="0">
				<annotation>
					<documentation>
						If the trial does not currently specify a
						ClinicalTrials.Gov ID
						(a.k.a NCT ID), you can provide one during
						the update.
						If the trial does have a ClinicalTrials.Gov ID already,
						your update
						will not be allowed to change it; an attempt to do so
						will be ignored by CTRP.
					</documentation>
				</annotation>
			</element>
			<element name="otherTrialID" minOccurs="0" maxOccurs="unbounded">
				<annotation>
					<documentation>Enter an additional trial identifier such as a
						unique identifier from other registries, NIH grant numbers, or
						protocol numbers assigned by the Review Board. Any values you
						provide during a trial update will be
						added to the list of the
						existing trial's other identifiers.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<minLength value="1" />
						<maxLength value="255" />
					</restriction>
				</simpleType>
			</element>
			<element name="accrualDiseaseTerminology" type="tns:AccrualDiseaseTerminology"
				minOccurs="0">
				<annotation>
					<documentation>A change to the trial's disease terminology
						will be
						ignored if the trial has
						accrued study subjects with disease codes
						under the existing terminology.
					</documentation>
				</annotation>
			</element>
			<element name="grant" type="tns:Grant" minOccurs="0"
				maxOccurs="unbounded">
				<annotation>
					<documentation>Grants specified during a trial update will be added
						to the existing trial's grant list.
					</documentation>
				</annotation>
			</element>
			<element name="trialStatus" type="tns:TrialStatusCode"
				minOccurs="0" />
			<element name="whyStopped" minOccurs="0">
				<annotation>
					<documentation>If the trial is Administratively Complete,
						Withdrawn, or Temporarily Closed, enter the reason that the study
						stopped.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<maxLength value="160" />
					</restriction>
				</simpleType>
			</element>
			<element name="trialStatusDate" type="date" minOccurs="0" />
			<element name="trialStartDate" type="tns:TrialDateType"
				minOccurs="0">
				<annotation>
					<documentation>If specified, its type can be either Anticipated or
						Actual.
					</documentation>
				</annotation>
			</element>
			<element name="primaryCompletionDate" type="tns:TrialDateType"
				nillable="true" minOccurs="0">
				<annotation>
					<documentation>Primary completion date is normally required for all
						trial submissions. The only exception is the DCP trials: they can
						have an empty Primary Completion Date of type 'N/A'.
					</documentation>
				</annotation>
			</element>
			<element name="completionDate" type="tns:TrialDateType"
				minOccurs="0">
				<annotation>
					<documentation>If specified, its type can be either Anticipated or
						Actual.
					</documentation>
				</annotation>
			</element>
			<element name="protocolDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>To ensure successful registration, upload a Protocol
						document.
					</documentation>
				</annotation>
			</element>
			<element name="irbApprovalDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>To ensure successful registration, upload a IRB
						Approval document
						document.
					</documentation>
				</annotation>
			</element>
			<element name="participatingSitesDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>This document includes site recruitment status and
						date, target accrual, and site principal investigators.
					</documentation>
				</annotation>
			</element>
			<element name="informedConsentDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>If the Protocol document does not include the
						Informed Consent and/or participating sites, upload the Informed
						Consent document.
					</documentation>
				</annotation>
			</element>
			<element name="otherDocument" type="tns:TrialDocument"
				minOccurs="0" maxOccurs="unbounded">
				<annotation>
					<documentation>Any other trial-related document.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>

	<complexType name="CompleteTrialRegistration" final="#all"
		block="#all">
		<annotation>
			<documentation>A request to register a new Complete trial in CTRP.
			</documentation>
		</annotation>
		<complexContent>
			<extension base="tns:BaseTrialInformation">
				<sequence>
					<element name="category" type="tns:TrialCategory" />
					<element name="trialOwner" minOccurs="0" maxOccurs="unbounded">
						<annotation>
							<documentation>
								Identifies an owner of this trial by an email
								address. Email address must be known to CTRP in order for the
								ownership
								to be established.
							</documentation>
						</annotation>
						<simpleType>
							<restriction base="string">
								<maxLength value="254" />
								<pattern
									value="[_\-a-zA-Z0-9\.\+]+@[a-zA-Z0-9](\.?[\-a-zA-Z0-9]*[a-zA-Z0-9])*" />
							</restriction>
						</simpleType>
					</element>
				</sequence>
			</extension>
		</complexContent>
	</complexType>

	<complexType name="CompleteTrialAmendment" final="#all"
		block="#all">
		<annotation>
			<documentation>A request to amend a Complete trial in CTRP.
			</documentation>
		</annotation>
		<complexContent>
			<extension base="tns:BaseTrialInformation">
				<sequence>
					<element name="amendmentNumber" minOccurs="0">
						<simpleType>
							<restriction base="string">
								<maxLength value="200" />
								<minLength value="1" />
							</restriction>
						</simpleType>
					</element>
					<element name="amendmentDate" type="date" />
					<element name="ctepIdentifier" type="string" minOccurs="0" />
					<element name="changeMemoDocument" type="tns:TrialDocument"
						minOccurs="0">
						<annotation>
							<documentation>Contains a summary of changes to the original, or
								last amended, trial submission.One or the other of the Change
								Memo and Protocol Highlight documents is required. You do not
								have to submit both of these documents.
							</documentation>
						</annotation>
					</element>
					<element name="protocolHighlightDocument" type="tns:TrialDocument"
						minOccurs="0">
						<annotation>
							<documentation>One or the other of the Change Memo and Protocol
								Highlight documents is required. You do not have to submit both
								of these documents.
							</documentation>
						</annotation>
					</element>
				</sequence>
			</extension>
		</complexContent>
	</complexType>


	<complexType name="BaseTrialInformation" abstract="true"
		block="restriction" final="restriction">
		<annotation>
			<documentation>Trial information common to Registration and Amendment
				requests.
			</documentation>
		</annotation>
		<sequence>
			<element name="clinicalTrialsDotGovXmlRequired" type="boolean">
				<annotation>
					<documentation>Indicates whether your trial needs to be submitted
						to/updated in ClinicalTrials.Gov via CTRP Nightly
						ClinicalTrials.Gov XML Upload process.
					</documentation>
				</annotation>
			</element>
			<element name="leadOrgTrialID">
				<simpleType>
					<restriction base="string">
						<maxLength value="30" />
						<minLength value="1" />
					</restriction>
				</simpleType>
			</element>
			<element ref="tns:clinicalTrialsDotGovTrialID" minOccurs="0" />
			<element name="dcpIdentifier" type="string" minOccurs="0" />
			<element name="otherTrialID" minOccurs="0" maxOccurs="unbounded">
				<annotation>
					<documentation>Enter an additional trial identifier such as a
						unique identifier from other registries, NIH grant numbers, or
						protocol numbers assigned by the Review Board. In case of an
						Amendment, the identifiers you specify will be
						appended to the
						existing ones.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<minLength value="1" />
						<maxLength value="255" />
					</restriction>
				</simpleType>
			</element>
			<element name="title">
				<annotation>
					<documentation>Enter the name of the clinical trial as it appears
						in the protocol document.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<maxLength value="4000" />
					</restriction>
				</simpleType>
			</element>
			<element name="phase" type="tns:TrialPhase" />
			<element name="pilot" type="boolean" minOccurs="0">
				<annotation>
					<documentation>If trial phase is not applicable, please indicate
						whether or not this is a pilot trial.
					</documentation>
				</annotation>
			</element>
			<element name="accrualDiseaseTerminology" type="tns:AccrualDiseaseTerminology" />
			<element name="primaryPurpose" type="tns:PrimaryPurpose" />
			<element name="primaryPurposeOtherDescription" type="tns:OtherDescription"
				minOccurs="0">
				<annotation>
					<documentation>If Trial Primary Purpose is 'Other', please provide
						an additional description of the trial's purpose using this
						element.
					</documentation>
				</annotation>
			</element>
			<choice>
				<annotation>
					<documentation>A trial's design can be either Interventional or
						Non-Interventional. Please provide corresponding design details.
						Please note: an Amendment cannot change
						a trial from Interventional
						to Non-Interventional or vice versa.
					</documentation>
				</annotation>
				<element name="interventionalDesign" type="tns:InterventionalTrialDesign" />
				<element name="nonInterventionalDesign" type="tns:NonInterventionalTrialDesign" />
			</choice>
			<element name="leadOrganization" type="tns:Organization" />
			<element name="pi" type="tns:Person" />
			<element name="sponsor" type="tns:Organization" minOccurs="0">
				<annotation>
					<documentation>Sponsor should not be specified if
						clinicalTrialsDotGovXmlRequired is false.
					</documentation>
				</annotation>
			</element>
			<element name="responsibleParty" type="tns:ResponsibleParty"
				minOccurs="0">
				<annotation>
					<documentation>Responsible Party should not be specified if
						clinicalTrialsDotGovXmlRequired is false.
					</documentation>
				</annotation>
			</element>
			<element name="summary4FundingSponsor" type="tns:Organization"
				maxOccurs="unbounded" />
			<element name="programCode" type="string" minOccurs="0" />
			<element name="fundedByNciGrant" type="boolean" />
			<element name="grant" type="tns:Grant" minOccurs="0"
				maxOccurs="unbounded" />
			<element name="trialStatus" type="tns:TrialStatusCode" />
			<element name="whyStopped" minOccurs="0">
				<annotation>
					<documentation>If the trial is Administratively Complete,
						Withdrawn, or Temporarily Closed, enter the reason that the study
						stopped.
					</documentation>
				</annotation>
				<simpleType>
					<restriction base="string">
						<maxLength value="160" />
					</restriction>
				</simpleType>
			</element>
			<element name="trialStatusDate" type="date" />
			<element name="trialStartDate" type="tns:TrialDateType">
				<annotation>
					<documentation>If specified, its type can be either Anticipated or
						Actual.
					</documentation>
				</annotation>
			</element>
			<element name="primaryCompletionDate" type="tns:TrialDateType"
				nillable="true">
				<annotation>
					<appinfo>
						<jaxb:property generateElementProperty="true" />
					</appinfo>
					<documentation>Primary completion date is normally required for all
						trial submissions. The only exception is the DCP trials: they can
						have an empty Primary Completion Date of type 'N/A'.
					</documentation>
				</annotation>
			</element>
			<element name="completionDate" type="tns:TrialDateType"
				minOccurs="0">
				<annotation>
					<documentation>If specified, its type can be either Anticipated or
						Actual.
					</documentation>
				</annotation>
			</element>
			<element name="ind" type="tns:IND_IDE" minOccurs="0"
				maxOccurs="unbounded" />
			<element name="ide" type="tns:IND_IDE" minOccurs="0"
				maxOccurs="unbounded" />
			<element name="regulatoryInformation" type="tns:RegulatoryInformation"
				minOccurs="0">
				<annotation>
					<documentation>Regulatory Information is required if
						clinicalTrialsDotGovXmlRequired is true and should not be
						specified otherwise.
					</documentation>
				</annotation>
			</element>
			<element name="protocolDocument" type="tns:TrialDocument">
				<annotation>
					<documentation>To ensure successful registration, upload a Protocol
						document.
					</documentation>
				</annotation>
			</element>
			<element name="irbApprovalDocument" type="tns:TrialDocument">
				<annotation>
					<documentation>To ensure successful registration, upload a IRB
						Approval document
						document.
					</documentation>
				</annotation>
			</element>
			<element name="participatingSitesDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>This document includes site recruitment status and
						date, target accrual, and site principal investigators.
					</documentation>
				</annotation>
			</element>
			<element name="informedConsentDocument" type="tns:TrialDocument"
				minOccurs="0">
				<annotation>
					<documentation>If the Protocol document does not include the
						Informed Consent and/or participating sites, upload the Informed
						Consent document.
					</documentation>
				</annotation>
			</element>
			<element name="otherDocument" type="tns:TrialDocument"
				minOccurs="0" maxOccurs="unbounded">
				<annotation>
					<documentation>Any other trial-related document.
					</documentation>
				</annotation>
			</element>
		</sequence>
	</complexType>

	<complexType name="ParticipatingSite" final="#all" block="#all">
		<annotation>
			<documentation>Represents a new or existing participating site on a
				trial: this
				includes organization information.
			</documentation>
		</annotation>
		<complexContent>
			<extension base="tns:BaseParticipatingSite">
				<sequence>
					<element name="organization" type="tns:Organization" />
				</sequence>
			</extension>
		</complexContent>
	</complexType>

	<complexType name="ParticipatingSiteUpdate" final="#all"
		block="#all">
		<annotation>
			<documentation>Represents an update to a participating site. Since an
				update to a site cannot change the organization, this type excludes
				the organization element.
			</documentation>
		</annotation>
		<complexContent>
			<extension base="tns:BaseParticipatingSite">
				<sequence />
			</extension>
		</complexContent>
	</complexType>

	<complexType name="BaseParticipatingSite" abstract="true">
		<annotation>
			<documentation>A participating site on a trial.
			</documentation>
		</annotation>
		<sequence>
			<element name="recruitmentStatus" type="tns:RecruitmentStatus" />
			<element name="recruitmentStatusDate" type="date" />
			<element name="localTrialIdentifier" type="string" />
			<element name="programCode" type="string" minOccurs="0" />
			<element name="openedForAccrual" type="date" minOccurs="0">
				<annotation>
					<documentation>
						Date when the site was opened for accrual can become
						mandatory depending
						on the recruitment status.
					</documentation>
				</annotation>
			</element>
			<element name="closedForAccrual" type="date" minOccurs="0">
				<annotation>
					<documentation>
						Date when the site was closed for accrual can become
						mandatory depending
						on the recruitment status.
					</documentation>
				</annotation>
			</element>
			<element name="targetAccrualNumber" type="nonNegativeInteger"
				minOccurs="0" />
			<element name="investigator" maxOccurs="unbounded" minOccurs="0">
				<complexType>
					<sequence>
						<element name="person" type="tns:Person" />
						<element name="role">
							<simpleType>
								<restriction base="string">
									<enumeration value="Principal Investigator" />
									<enumeration value="Sub Investigator" />
								</restriction>
							</simpleType>
						</element>
						<element name="primaryContact" type="boolean">
							<annotation>
								<documentation>Specifies whether or not this investigator should
									be designated as the primary contact for the site.
								</documentation>
							</annotation>
						</element>
					</sequence>
				</complexType>
			</element>
		</sequence>
	</complexType>

</schema>