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This section provides instructions for registering, updating, and amending Complete and Abbreviated trials via the NCI CTRP Trial Registration REST Service.

Introduction

Trial Registration REST Service is a CTRP Web Service that provides the following operations in a REST-like fashion:

  • Register an Abbreviated trial in CTRP from ClinicalTrials.gov using a ClinicalTrials.gov Trial Identifier
  • Update an Abbreviated trial in CTRP
  • Register a Complete interventional or non-interventional trial in CTRP
  • Update a Complete trial in CTRP
  • Amend a Complete trial in CTRP

The service uses XML for data exchange.

Note
titleProgram Codes

The program codes feature (not to be confused with NCI Divisions Division and ProgramsProgram Values) has been enhanced for the 4.4 release. The system ignores program codes unless the trial is one of the following:

  • Complete trial with a lead organization as a member of your cancer center family of organizations.
  • Abbreviated trial where such a member is a participant.

The system validates program code values against those listed on the Manage Program Codes Master List page for your affiliated cancer center. For details, refer to Managing Program Codes.

Service Endpoints

...

Inside the NIH Firewall (VPN required)

...

...

Outside of the NIH Firewall

Access Requirements

...

To use the service, you must have a valid NCI LDAP account and a CTRP account. For instructions, refer to Creating New NCI CTRP User Accounts. All service endpoints require HTTP Basic authentication with your NCI LDAP username and password.

XML Schema

...

The service uses XML for data exchange.All XML elements going in or out of the service are defined and validated against the following XML schemas:

XML schemas are well-annotated with inline documentation that explains the purpose and meaning of various elements, types, and attributes. These schemas specify which elements are required and the required order of those elements. Specific elements required for service operations are explained in the sections below.

Persons and Organizations - Requirements and Recommendations

...

Registering or amending Complete trials in the CTRP involves organizations and persons that have the following roles in clinical trials: lead organization, sponsor, principal investigator, and so on.

...

Note
You must have a user account with appropriate LDAP membership to access the PO User's Guide.

...

Use person identifiers (PO IDs) and organization identifiers (CTEP IDs) when you register a trial whenever possible. If they do not already exist, request that they be created prior to trial registration, by submitting a request to the CTRO at ncictro@mail.nih.gov

...

Tip
titleUse PO Web Services API

We strongly recommended that you exercise PO Web Services API separately in order to find persons and organizations of interest prior to registering a trial. For instructions, refer to Person and Organization Service. Once you find a person or organization, you can use their IDs within a trial registration packet as shown in API examples below. This helps to minimize duplicates in the CTRP system.

API Specification

Register an

API Specification

Register an Abbreviated Trial

Register an Abbreviated trial in CTRP by pulling trial data from ClinicalTrials.gov using a ClinicalTrials.gov Trial Identifier.

HTTP MethodPOST
URL

/trials/abbreviated/{nct}

Parameters

{nct}. ClinicalTrials.gov Trial Identifier

Request BodyEmpty
Response BodyXML document with
TrialRegistrationConfirmation
 

MIME Type: application/xml
HTTP Response Code

200. Success

400. Validation error

401. Invalid username/password or insufficient permissions to access the service.

412. A study with the given identifier already exists in CTRP.

500. Error: Duplicate Trial Submission: A trial exists in the system with the same Lead Organization Trial Identifier for the selected Lead Organization

Examples

URL: https://trials-stage.nci.nih.gov/services/trials/abbreviated/NCT02208700

Response:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<TrialRegistrationConfirmation xmlns="gov.nih.nci.pa.webservices.types"
    xmlns:ns2="gov.nih.nci.po.webservices.types.trimmed">
    <paTrialID>137908558</paTrialID>
    <nciTrialID>NCI-2014-00496</nciTrialID>
</TrialRegistrationConfirmation>

...

HTTP MethodPOST
URL

/trials/abbreviated/{idType}/{trialID}

Parameters

{idType}. Type of identifier you want to use to identify a trial in CTRP. Possible values: pa, nci, ctep.

{trialID}. Trial identifier value itself.


Request BodyXML document with
AbbreviatedTrialUpdate

MIME Type: application/xml

Response BodyXML document with
TrialRegistrationConfirmation

MIME Type: application/xml

HTTP Response Code

200. Success

400. Validation error (including the condition when you are not allowed to update a particular trial)

401. Invalid username/password or insufficient permissions to access the service.

404. One of the Persons/Organizations acting on the trial was not found in PO

500. Internal server error

Examples

URL: https://trials-stage.nci.nih.gov/services/trials/abbreviated/nci/NCI-2014-00496

Request:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?><tns>
<tns:AbbreviatedTrialUpdate 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
	    xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
	    xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">

	<tns:clinicalTrialsDotGovTrialID>NCT234234234<clinicalTrialsDotGovTrialID>NCT87654321</tns:clinicalTrialsDotGovTrialID>
	<tns:irbApprovalDocument filename="irb_u.pdf">dGVzdA==</tns:irbApprovalDocument>
	<tns:informedConsentDocument filename="consent_u.pdf">dGVzdA==</tns:informedConsentDocument>
	<tns:otherDocument filename="other_u1.pdf">dGVzdA==</tns:otherDocument>	
</tns:AbbreviatedTrialUpdate>

Response:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<TrialRegistrationConfirmation 
    xmlns="gov.nih.nci.pa.webservices.types"
    xmlns:ns2="gov.nih.nci.po.webservices.types.trimmed">
    <paTrialID>137908558</paTrialID>
    <nciTrialID>NCI-2014-00496</nciTrialID>
</TrialRegistrationConfirmation>

...

HTTP MethodPOST
URL/trials/complete
Request BodyXML document with
CompleteTrialRegistration

MIME Type: application/xml

Response BodyXML document with
TrialRegistrationConfirmation

MIME Type: application/xml.
HTTP Response Code

200. Success

400. Validation error

401. Invalid username/password or insufficient permissions to access the service.

404. One of the Persons/Organizations acting on the trial was not found in PO

500. Internal server error

Examples

URL: https://trials-stage.nci.nih.gov/services/trials/complete

Request (referring to existing Organizations and Persons by ID):

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialRegistration 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
                               xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
                               xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">

    
    <tns:leadOrgTrialID>REST00001</tns:leadOrgTrialID>
    <tns:clinicalTrialsDotGovTrialID>NCT12345678</tns:clinicalTrialsDotGovTrialID>
    <tns:dcpIdentifier>DCP123</tns:dcpIdentifier>
    <tns:otherTrialID>OTHER00000000001</tns:otherTrialID>
    <tns:title>RESTtitle>A Phase I Study of REST Trial Test<Registration</tns:title>
    <tns:phase>I</tns:phase>
    <tns:pilot>false</tns:pilot>
    <tns:accrualDiseaseTerminology>SDC</tns:accrualDiseaseTerminology>
    <tns:primaryPurpose>Other</tns:primaryPurpose>
    <tns:primaryPurposeOtherDescription>PP Other Description<primaryPurposeOtherDescription>Additional description of the trial's purpose</tns:primaryPurposeOtherDescription>
    <tns:interventionalDesign>
        <tns:secondaryPurpose>Other</tns:secondaryPurpose>
        <tns:secondaryPurposeOtherDescription>Secondary Other Descr<secondaryPurposeOtherDescription>Additional description of the trial's purpose</tns:secondaryPurposeOtherDescription>
    </tns:interventionalDesign>
    <tns:leadOrganization>
        <tns:existingOrganization>
            <tns:poID>1</tns:poID>
        </tns:existingOrganization>
    </tns:leadOrganization>
    <tns:pi>
        <tns:existingPerson>
            <tns:poID>1<poID>10</tns:poID>
        </tns:existingPerson>
    </tns:pi>
    <tns:sponsor>
        <tns:existingOrganization>
            <tns:poID>2</tns:poID>
        </tns:existingOrganization>
    </tns:sponsor>
    <tns:responsibleParty>
        <tns:type>Sponsor</tns:type>
    </tns:responsibleParty>
    <tns:summary4FundingSponsor>
        <tns:existingOrganization>
            <tns:poID>3</tns:poID>
        </tns:existingOrganization>
    </tns:summary4FundingSponsor>
    <tns:programCode>REST_PG01<programCode>PG00001</tns:programCode>
    <tns:fundedByNciGrant>false</tns:fundedByNciGrant>
    <tns:grant>
        <tns:fundingMechanism>B01</tns:fundingMechanism>
        <tns:nihInstitutionCode>AA</tns:nihInstitutionCode>
        <tns:serialNumber>111111</tns:serialNumber>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:fundingPercentage>100.0</tns:fundingPercentage>
    </tns:grant>
    <tns:trialStatus>In Review</tns:trialStatus>
    <tns:whyStopped>If study stopped, enter the reason why.</tns:whyStopped>
    <tns:trialStatusDate>2014-07-15</tns:trialStatusDate>
    <tns:trialStartDate type="Actual">2014-07-15</tns:trialStartDate>
    <tns:primaryCompletionDate type="Anticipated">2018-07-15</tns:primaryCompletionDate>
    <tns:completionDate type="Anticipated">2018-07-15</tns:completionDate>
    <tns:ind>
        <tns:number>111111</tns:number>
        <tns:grantor>CDER</tns:grantor>
        <tns:holderType>NIH</tns:holderType>
        <tns:nihInstitution>NEI</tns:nihInstitution>
        <tns:expandedAccess>true</tns:expandedAccess>
        <tns:expandedAccessRecord>NCT12345688</tns:expandedAccessRecord>
        <tns:expandedAccessType>Available</tns:expandedAccessType>
        <tns:exempt>true</tns:exempt>
    </tns:ind>
    <tns:ide>
        <tns:number>222222</tns:number>
        <tns:grantor>CDRH</tns:grantor>
        <tns:holderType>NCI</tns:holderType>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:expandedAccess>true<expandedAccess>unknown</tns:expandedAccess>
        <tns:expandedAccessRecord>NCT12345688<</tns:expandedAccessRecord>ide>
        <tns:expandedAccessType>Available</tns:expandedAccessType>regulatoryInformation>
        <tns:exempt>true<fdaRegulatedDrug>true</tns:exempt>fdaRegulatedDrug>
    </tns:ide>
    <tns:regulatoryInformation>
        <tns:country>USA<fdaRegulatedDevice>true</tns:country>fdaRegulatedDevice>
        <tns:authorityName>Federal Government</tns:authorityName>
        <tns:fdaRegulatedDrug>true</tns:fdaRegulatedDrug>
        <tns:fdaRegulatedDevice>true</tns:fdaRegulatedDevice>
        <tns:approvalClearance>false</tns:approvalClearance>
        <tns:marketSurveillance>true</tns:marketSurveillance>
        <tns:usaExport>true</tns:usaExport>
        <tns:fdaRegulated>true</tns:fdaRegulated>
        <tns:section801>true</tns:section801>
        <tns:delayedPosting>false</tns:delayedPosting>
        <tns:dataMonitoringCommitteeAppointed>true</tns:dataMonitoringCommitteeAppointed>
    </tns:regulatoryInformation>
    <tns:protocolDocument filename="protocol.pdf">dGVzdA==</tns:protocolDocument>
    <tns:irbApprovalDocument filename="irb.pdf">dGVzdA==</tns:irbApprovalDocument>
    <tns:participatingSitesDocument
            filename="sites.pdf">dGVzdA==</tns:participatingSitesDocument>
    <tns:informedConsentDocument filename="consent.pdf">dGVzdA==</tns:informedConsentDocument>
    <tns:otherDocument filename="other.pdf">dGVzdA==</tns:otherDocument>
    <tns:category>Externally Peer-Reviewed</tns:category>
    <tns:trialOwner>denis.krylov@semanticbits.com</tns:trialOwner>
</tns:CompleteTrialRegistration>

Request (non-interventional trial):

Code Block
languagehtml/xml
collapsetrue
<tns:CompleteTrialRegistration xmlns:tns="gov.nih.nci.pa.webservices.types"
	xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
	xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">
	
	<tns:leadOrgTrialID>UPCC 34890534</tns:leadOrgTrialID>
	<tns:clinicalTrialsDotGovTrialID>NCT01994850</tns:clinicalTrialsDotGovTrialID>
	<tns:otherTrialID>818280234</tns:otherTrialID>
	<tns:title>A Phase I/II Study Of Brentuximab Vedotin In Combination With Multi-Agent Chemotherapy</tns:title>
	<tns:phase>I</tns:phase>
	<tns:pilot>false</tns:pilot>
	<tns:accrualDiseaseTerminology>ICD10</tns:accrualDiseaseTerminology>
	<tns:primaryPurpose>Other</tns:primaryPurpose>
	<tns:primaryPurposeOtherDescription>Determine maximum tolerated dose (MTD) of brentuximab vedotin</tns:primaryPurposeOtherDescription>
	<tns:nonInterventionalDesign>
		<tns:trialType>Observational</tns:trialType>
		<tns:studyModelCode>Other</tns:studyModelCode>
		<tns:studyModelCodeOtherDescription>studyModelCode other</tns:studyModelCodeOtherDescription>
		<tns:timePerspectiveCode>Other</tns:timePerspectiveCode>
		<tns:timePerspectiveCodeOtherDescription>timePerspectiveCode other</tns:timePerspectiveCodeOtherDescription>
	</tns:nonInterventionalDesign>
	<tns:leadOrganization>
		<tns:existingOrganization>
			<tns:poID>1</tns:poID>
		</tns:existingOrganization>
	</tns:leadOrganization>
	<tns:pi>
		<tns:existingPerson>
			<tns:poID>1</tns:poID>
		</tns:existingPerson>
	</tns:pi>
	<tns:sponsor>
		<tns:existingOrganization>
			<tns:poID>2</tns:poID>
		</tns:existingOrganization>
	</tns:sponsor>
	<tns:responsibleParty>
		<tns:type>Sponsor</tns:type>
	</tns:responsibleParty>
	<tns:summary4FundingSponsor>
		<tns:existingOrganization>
			<tns:poID>3</tns:poID>
		</tns:existingOrganization>
	</tns:summary4FundingSponsor>
	<tns:programCode>PG00001</tns:programCode>
	<tns:fundedByNciGrant>false</tns:fundedByNciGrant>
	<tns:grant>
		<tns:fundingMechanism>B09</tns:fundingMechanism>
		<tns:nihInstitutionCode>AA</tns:nihInstitutionCode>
		<tns:serialNumber>111111</tns:serialNumber>
		<tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
		<tns:fundingPercentage>100.0</tns:fundingPercentage>
	</tns:grant>
	<tns:trialStatus>In Review</tns:trialStatus>
	<tns:whyStopped></tns:whyStopped>
	<tns:trialStatusDate>2014-07-15</tns:trialStatusDate>
	<tns:trialStartDate type="Actual">2014-07-15</tns:trialStartDate>
	<tns:primaryCompletionDate type="Anticipated">2016-07-15</tns:primaryCompletionDate>
	<tns:completionDate type="Anticipated">2016-07-15</tns:completionDate>
	<tns:ind>
		<tns:number>111111</tns:number>
		<tns:grantor>CDER</tns:grantor>
		<tns:holderType>NIH</tns:holderType>
		<tns:nihInstitution>NEI</tns:nihInstitution>
		<tns:expandedAccess>true</tns:expandedAccess>
		<tns:expandedAccessType>Available</tns:expandedAccessType>
		<tns:exempt>true</tns:exempt>
	</tns:ind>
	<tns:ide>
		<tns:number>222222</tns:number>
		<tns:grantor>CDRH</tns:grantor>
		<tns:holderType>NCI</tns:holderType>
		<tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
		<tns:expandedAccess>true</tns:expandedAccess>
		<tns:expandedAccessType>Available</tns:expandedAccessType>
		<tns:exempt>true</tns:exempt>
	</tns:ide>
	<tns:regulatoryInformation>
		<tns:country>USA</tns:country>
		<tns:authorityName>Federal Government</tns:authorityName>
		:approvalClearance>false</tns:approvalClearance>
        <tns:marketSurveillance>true</tns:marketSurveillance>
        <tns:usaExport>true</tns:usaExport>
        <tns:fdaRegulated>true</tns:fdaRegulated>
		        <tns:section801>true</tns:section801>
		        <tns:delayedPosting>true<delayedPosting>false</tns:delayedPosting>
		        <tns:dataMonitoringCommitteeAppointed>true</tns:dataMonitoringCommitteeAppointed>
	    </tns:regulatoryInformation>
	
    <tns:protocolDocument filename="protocol.pdf">dGVzdA==</tns:protocolDocument>
	    <tns:irbApprovalDocument filename="irb.pdf">dGVzdA==</tns:irbApprovalDocument>
	    <tns:participatingSitesDocument
		            filename="sites.pdf">dGVzdA==</tns:participatingSitesDocument>
	    <tns:informedConsentDocument filename="consent.pdf">dGVzdA==</tns:informedConsentDocument>
	    <tns:otherDocument filename="other.pdf">dGVzdA==</tns:otherDocument>
	    <tns:category>Externally Peer-Reviewed</tns:category>
	    <tns:trialOwner>submitter-ci@example.com</tns:trialOwner>
</tns:CompleteTrialRegistration>

Request (trial where submission to ClinicalTrials.gov is not requirednon-interventional trial):

Code Block
languagehtml/xml
collapsetrue
<tns:CompleteTrialRegistration<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialRegistration 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
	xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
	xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">
	
    
	<tns:leadOrgTrialID>UPCC 34890534<leadOrgTrialID>REST00001</tns:leadOrgTrialID>
	<tns:clinicalTrialsDotGovTrialID>NCT01994850<clinicalTrialsDotGovTrialID>NCT01234567</tns:clinicalTrialsDotGovTrialID>
	<tns:otherTrialID>818280234<otherTrialID>OTHER00000000002</tns:otherTrialID>
	<tns:title>A Phase I/II Study Ofof BrentuximabREST Vedotin In Combination With Multi-Agent Chemotherapy<Trial Registration</tns:title>
	<tns:phase>I</tns:phase>
	<tns:pilot>false</tns:pilot>
	<tns:accrualDiseaseTerminology>ICD10</tns:accrualDiseaseTerminology>
	<tns:primaryPurpose>Other</tns:primaryPurpose>
	<tns:primaryPurposeOtherDescription>DetermineprimaryPurposeOtherDescription>Additional maximumdescription toleratedof dose (MTD) of brentuximab vedotin<the trial's purpose</tns:primaryPurposeOtherDescription>
	<tns:interventionalDesign>
	<tns:nonInterventionalDesign>
		<tns:trialType>Observational</tns:trialType>
		<tns:studyModelCode>Other</tns:studyModelCode>
		<tns:studyModelCodeOtherDescription>studyModelCode other</tns:studyModelCodeOtherDescription>
		<tns:secondaryPurpose>Other<timePerspectiveCode>Other</tns:secondaryPurpose>timePerspectiveCode>
		<tns:secondaryPurposeOtherDescription>SecondarytimePerspectiveCodeOtherDescription>timePerspectiveCode Other Description<other</tns:secondaryPurposeOtherDescription>timePerspectiveCodeOtherDescription>
	</tns:interventionalDesign>nonInterventionalDesign>
	<tns:leadOrganization>
		<tns:existingOrganization>
			<tns:poID>1</tns:poID>
		</tns:existingOrganization>
	</tns:leadOrganization>
	<tns:pi>
		<tns:existingPerson>
			<tns:poID>1<poID>10</tns:poID>
		</tns:existingPerson>
	</tns:pi>
	<tns:sponsor>
		<tns:existingOrganization>
			<tns:poID>2</tns:poID>
		</tns:existingOrganization>
	</tns:sponsor>
	<tns:responsibleParty>
		<tns:type>Sponsor</tns:type>
	</tns:responsibleParty>
	<tns:summary4FundingSponsor>
		<tns:existingOrganization>
			<tns:poID>3</tns:poID>
		</tns:existingOrganization>
	</tns:summary4FundingSponsor>
	<tns:programCode>PG00001</tns:programCode>
	<tns:fundedByNciGrant>false</tns:fundedByNciGrant>
	<tns:grant>
		<tns:fundingMechanism>B09</tns:fundingMechanism>
		<tns:nihInstitutionCode>AA</tns:nihInstitutionCode>
		<tns:serialNumber>111111</tns:serialNumber>
		<tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
		<tns:fundingPercentage>100.0</tns:fundingPercentage>
	</tns:grant>
	<tns:trialStatus>In Review</tns:trialStatus>
	<tns:whyStopped><trialStatus>
	<tns:whyStopped>If study stopped, enter the reason why.</tns:whyStopped>
	<tns:trialStatusDate>2014-07-15</tns:trialStatusDate>
	<tns:trialStartDate type="Actual">2014-07-15</tns:trialStartDate>
	<tns:primaryCompletionDate type="Anticipated">2016>2018-07-15</tns:primaryCompletionDate>
	<tns:completionDate type="Anticipated">2016>2018-07-15</tns:completionDate>
	<tns:ind>
		<tns:number>111111</tns:number>
		<tns:grantor>CDER</tns:grantor>
		<tns:holderType>NIH</tns:holderType>
		<tns:nihInstitution>NEI</tns:nihInstitution>
		<tns:expandedAccess>true</tns:expandedAccess>
        <tns:expandedAccessRecord>NCT12345688</tns:expandedAccessRecord>
	</tns:completionDate>ind>
	<tns:ind>ide>
		<tns:number>111111<number>222222</tns:number>
		<tns:grantor>CDER<grantor>CDRH</tns:grantor>
		<tns:holderType>NIH<holderType>NCI</tns:holderType>
		<tns:nihInstitution>NEI<nciDivisionProgramCode>CCR</tns:nihInstitution>nciDivisionProgramCode>
		<tns:expandedAccess>true<expandedAccess>unknown</tns:expandedAccess>
		<tns:expandedAccessType>Available<</tns:expandedAccessType>ide>
		<tns:regulatoryInformation>
        <tns:exempt>true<fdaRegulatedDrug>true</tns:exempt>
	<fdaRegulatedDrug>
        <tns:fdaRegulatedDevice>true</tns:ind>
	<tns:ide>
		<tns:number>222222<fdaRegulatedDevice>
        <tns:approvalClearance>false</tns:number>
		approvalClearance>
        <tns:grantor>CDRH<marketSurveillance>true</tns:grantor>
		marketSurveillance>
        <tns:holderType>NCI<usaExport>true</tns:holderType>usaExport>
		<tns:nciDivisionProgramCode>CCR<fdaRegulated>true</tns:nciDivisionProgramCode>fdaRegulated>
		<tns:expandedAccess>true<section801>true</tns:expandedAccess>section801>
		<tns:expandedAccessType>Available<delayedPosting>false</tns:expandedAccessType>delayedPosting>
		<tns:exempt>true<dataMonitoringCommitteeAppointed>true</tns:exempt>dataMonitoringCommitteeAppointed>
	</tns:ide>	regulatoryInformation>
	<tns:protocolDocument filename="protocol.pdf">dGVzdA==</tns:protocolDocument>
	<tns:irbApprovalDocument filename="irb.pdf">dGVzdA==</tns:irbApprovalDocument>
	<tns:participatingSitesDocument
		filename="sites.pdf">dGVzdA==</tns:participatingSitesDocument>
	<tns:informedConsentDocument filename="consent.pdf">dGVzdA==</tns:informedConsentDocument>
	<tns:otherDocument filename="other.pdf">dGVzdA==</tns:otherDocument>
	<tns:category>Externally Peer-Reviewed</tns:category>
	<tns:trialOwner>submitter-ci@example.com</tns:trialOwner>
</tns:CompleteTrialRegistration>

Request (trial with minimum data):

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialRegistration 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
	xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
	xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">	

    
	<tns:leadOrgTrialID>UPCC 34890534<leadOrgTrialID>REST00001</tns:leadOrgTrialID>
	<tns:title>A Phase I/II Study Ofof Brentuximab Vedotin In Combination With Multi-Agent Chemotherapy<REST Trial Registration</tns:title>
	<tns:phase>I</tns:phase>
	<tns:accrualDiseaseTerminology>ICD10</tns:accrualDiseaseTerminology>
	<tns:primaryPurpose>Treatment</tns:primaryPurpose>
	<tns:interventionalDesign />
	<tns:leadOrganization>
		<tns:existingOrganization>
			<tns:poID>1</tns:poID>
		</tns:existingOrganization>
	</tns:leadOrganization>
	<tns:pi>
		<tns:existingPerson>
			<tns:poID>1<poID>10</tns:poID>
		</tns:existingPerson>
	</tns:pi>
	<tns:summary4FundingSponsor>
		<tns:existingOrganization>
			<tns:poID>2</tns:poID>
		</tns:existingOrganization>
	</tns:summary4FundingSponsor>
	<tns:fundedByNciGrant>false</tns:fundedByNciGrant>
	<tns:trialStatus>In Review</tns:trialStatus>
	<tns:trialStatusDate>2001-01-01</tns:trialStatusDate>
	<tns:trialStartDate type="Actual">2001-01-01
	</tns:trialStartDate>
	<tns:primaryCompletionDate type="Actual">2001-01-01
	</tns:primaryCompletionDate>
	<tns:protocolDocument filename="protocol.pdf">MA==
	</tns:protocolDocument>
	<tns:irbApprovalDocument filename="irb.pdf">MA==
	</tns:irbApprovalDocument>
	<tns:category>National</tns:category>
	<tns:trialOwner>submitter-ci@example.com</tns:trialOwner>
</tns:CompleteTrialRegistration>

Request (trial where responsible party is Sponsor-Investigator):

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialRegistration 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
	xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
	xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">

    
	<tns:leadOrgTrialID>UPCC 34890534<leadOrgTrialID>REST00001</tns:leadOrgTrialID>
	<tns:clinicalTrialsDotGovTrialID>NCT01994850<clinicalTrialsDotGovTrialID>NCT12345678</tns:clinicalTrialsDotGovTrialID>
	<tns:otherTrialID>818280234<otherTrialID>OTHER00000000001</tns:otherTrialID>
	<tns:title>A Phase I/II Study Ofof BrentuximabREST Vedotin In Combination With Multi-Agent Chemotherapy<Trial Registration</tns:title>
	<tns:phase>I</tns:phase>
	<tns:pilot>false</tns:pilot>
	<tns:accrualDiseaseTerminology>ICD10</tns:accrualDiseaseTerminology>
	<tns:primaryPurpose>Other</tns:primaryPurpose>
	<tns:primaryPurposeOtherDescription>DetermineprimaryPurposeOtherDescription>Additional maximumdescription toleratedof dose (MTD) of brentuximab vedotin<the trial's purpose</tns:primaryPurposeOtherDescription>
	<tns:interventionalDesign>
		<tns:secondaryPurpose>Other</tns:secondaryPurpose>
		<tns:secondaryPurposeOtherDescription>Secondary Other Description<secondaryPurposeOtherDescription>Additional description of the trial's purpose</tns:secondaryPurposeOtherDescription>
	</tns:interventionalDesign>
	<tns:leadOrganization>
		<tns:existingOrganization>
			<tns:poID>1</tns:poID>
		</tns:existingOrganization>
	</tns:leadOrganization>
	<tns:pi>
		<tns:existingPerson>
			<tns:poID>1<poID>10</tns:poID>
		</tns:existingPerson>
	</tns:pi>
	<tns:sponsor>
		<tns:existingOrganization>
			<tns:poID>2</tns:poID>
		</tns:existingOrganization>
	</tns:sponsor>
	<tns:responsibleParty>
		<tns:type>Sponsor-Investigator</tns:type>
		<tns:investigator>
		<tns:existingPerson>
			<tns:poID>1</tns:poID>
		</tns:existingPerson>
		</tns:investigator>
		<tns:investigatorTitle>CEO &amp; Chairman</tns:investigatorTitle>
	</tns:responsibleParty>
	<tns:summary4FundingSponsor>
		<tns:existingOrganization>
			<tns:poID>3</tns:poID>
		</tns:existingOrganization>
	</tns:summary4FundingSponsor>
	<tns:programCode>PG00001</tns:programCode>
	<tns:fundedByNciGrant>false</tns:fundedByNciGrant>
	<tns:grant>
		<tns:fundingMechanism>B09</tns:fundingMechanism>
		<tns:nihInstitutionCode>AA</tns:nihInstitutionCode>
		<tns:serialNumber>111111</tns:serialNumber>
		<tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
		<tns:fundingPercentage>100.0</tns:fundingPercentage>
	</tns:grant>
	<tns:trialStatus>In Review</tns:trialStatus>
	<tns:whyStopped><whyStopped>If study stopped, enter the reason why.</tns:whyStopped>
	<tns:trialStatusDate>2014-07-15</tns:trialStatusDate>
	<tns:trialStartDate type="Actual">2014-07-15</tns:trialStartDate>
	<tns:primaryCompletionDate type="Anticipated">2016>2018-07-15</tns:primaryCompletionDate>
	<tns:completionDate type="Anticipated">2016>2018-07-15</tns:completionDate>
	<tns:ind>
		<tns:number>111111</tns:number>
		<tns:grantor>CDER</tns:grantor>
		<tns:holderType>NIH</tns:holderType>
		<tns:nihInstitution>NEI</tns:nihInstitution>
		<tns:expandedAccess>true</tns:expandedAccess>
		        <tns:expandedAccessType>Available<expandedAccessRecord>NCT12345688</tns:expandedAccessType>
		<tns:exempt>true</tns:exempt>expandedAccessRecord>
	</tns:ind>
	<tns:ide>
		<tns:number>222222</tns:number>
		<tns:grantor>CDRH</tns:grantor>
		<tns:holderType>NCI</tns:holderType>
		<tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
		<tns:expandedAccess>true<expandedAccess>unknown</tns:expandedAccess>
	</tns:ide>
	<tns:expandedAccessType>Available<regulatoryInformation>
        <tns:fdaRegulatedDrug>true</tns:expandedAccessType>
		fdaRegulatedDrug>
        <tns:exempt>true<fdaRegulatedDevice>true</tns:exempt>
	<fdaRegulatedDevice>
        <tns:approvalClearance>false</tns:ide>
	<tns:regulatoryInformation>
		<tns:country>USA<approvalClearance>
        <tns:marketSurveillance>true</tns:country>
		<tns:authorityName>Federal Government<marketSurveillance>
        <tns:usaExport>true</tns:authorityName>usaExport>
		<tns:fdaRegulated>true</tns:fdaRegulated>
		<tns:section801>true</tns:section801>
		<tns:delayedPosting>true<delayedPosting>false</tns:delayedPosting>
		<tns:dataMonitoringCommitteeAppointed>true</tns:dataMonitoringCommitteeAppointed>
	</tns:regulatoryInformation>
	<tns:protocolDocument filename="protocol.pdf">dGVzdA==</tns:protocolDocument>
	<tns:irbApprovalDocument filename="irb.pdf">dGVzdA==</tns:irbApprovalDocument>
	<tns:participatingSitesDocument
		filename="sites.pdf">dGVzdA==</tns:participatingSitesDocument>
	<tns:informedConsentDocument filename="consent.pdf">dGVzdA==</tns:informedConsentDocument>
	<tns:otherDocument filename="other.pdf">dGVzdA==</tns:otherDocument>
	<tns:category>Externally Peer-Reviewed</tns:category>
	<tns:trialOwner>submitter-ci@example.com</tns:trialOwner>
</tns:CompleteTrialRegistration>

Response:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<TrialRegistrationConfirmation xmlns="gov.nih.nci.pa.webservices.types"
    xmlns:ns2="gov.nih.nci.po.webservices.types.trimmed">
    <paTrialID>137908558</paTrialID>
    <nciTrialID>NCI-2014-00496</nciTrialID>
</TrialRegistrationConfirmation>

...

HTTP MethodPOST
URL

/trials/complete/{idType}/{trialID}

Parameters

{idType}. Type of identifier you want to use to identify a trial in CTRP. Possible values: pa, nci, ctep, dcp.

{trialID}. Trial identifier value itself.

Request BodyXML document with
CompleteTrialUpdate

MIME Type: application/xml

Response BodyXML document with
TrialRegistrationConfirmation
MIME Type: application/xml
HTTP Response Code

200. Success

400. Validation error (including the condition when you are not allowed to update a particular trial)

401. Invalid username/password or insufficient permissions to access the service.

500. Internal server error

Examples

URL: https://trials-stage.nci.nih.gov/services/trials/complete/nci/NCI-2014-00496

Request:

Code Block
languagehtml/xml
collapsetrue
<tns:CompleteTrialUpdate<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialUpdate 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
    xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
    xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">    

    <tns:clinicalTrialsDotGovTrialID>NCT11111111111<clinicalTrialsDotGovTrialID>NCT12345678</tns:clinicalTrialsDotGovTrialID>
    <tns:otherTrialID>ADDED01<otherTrialID>OTHER00000000001</tns:otherTrialID>    
    <tns:accrualDiseaseTerminology>ICD-O-3</tns:accrualDiseaseTerminology>
    <tns:grant>
        <tns:fundingMechanism>C06</tns:fundingMechanism>
        <tns:nihInstitutionCode>AA</tns:nihInstitutionCode>
        <tns:serialNumber>111111</tns:serialNumber>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:fundingPercentage>100.0</tns:fundingPercentage>
    </tns:grant>
    <tns:trialStatus>Approved</tns:trialStatus>
    <tns:whyStopped><whyStopped>If study stopped, enter the reason why.</tns:whyStopped>
    <tns:trialStatusDate>2014-07-07</tns:trialStatusDate>
    <tns:trialStartDate type="Actual">2010-01-11</tns:trialStartDate>
    <tns:primaryCompletionDate type="Anticipated">2025-01-01</tns:primaryCompletionDate>
    <tns:completionDate type="Anticipated">2050-01-01</tns:completionDate>
    <tns:protocolDocument filename="protocol_updated.pdf">dGVzdA==</tns:protocolDocument>
    <tns:irbApprovalDocument filename="irb_updated.pdf">dGVzdA==</tns:irbApprovalDocument>
    <tns:participatingSitesDocument
        filename="sites_updated.pdf">dGVzdA==</tns:participatingSitesDocument>
    <tns:informedConsentDocument filename="consent_updated.pdf">dGVzdA==</tns:informedConsentDocument>
    <tns:otherDocument filename="other_updated.pdf">dGVzdA==</tns:otherDocument>
	<tns:trialOwner>submitter-ci@example.com</tns:trialOwner>
</tns:CompleteTrialUpdate>

Response:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<TrialRegistrationConfirmation xmlns="gov.nih.nci.pa.webservices.types"
    xmlns:ns2="gov.nih.nci.po.webservices.types.trimmed">
    <paTrialID>137908558</paTrialID>
    <nciTrialID>NCI-2014-00496</nciTrialID>
</TrialRegistrationConfirmation>

...

HTTP MethodPUT
URL

/trials/complete/{idType}/{trialID}

Parameters

{idType}. Type of identifier you want to use to identify a trial in CTRP. Possible values: pa, nci, ctep, dcp.

{trialID}. Trial identifier value itself.

Request BodyXML document with
CompleteTrialAmendment
MIME Type: application/xml
Response BodyXML document with
TrialRegistrationConfirmation

MIME Type: application/xml

HTTP Response Code

200. Success

400. Validation error (including the condition when you are not allowed to amend a particular trial)

401. Invalid username/password or insufficient permissions to access the service.

404. One of the Persons/Organizations acting on the trial was not found in PO

500. Internal server error

Examples

URL: https://trials-stage.nci.nih.gov/services/trials/complete/nci/NCI-2014-00496

Request:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<tns:CompleteTrialAmendment 
    xmlns:tns="gov.nih.nci.pa.webservices.types"
    xmlns:tns1="gov.nih.nci.po.webservices.types.trimmed" 
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
    xsi:schemaLocation="gov.nih.nci.pa.webservices.types ../../src/resources/ws.xsd ">

    
    <tns:leadOrgTrialID>UPCC 34890534<leadOrgTrialID>REST00001</tns:leadOrgTrialID>
    <tns:clinicalTrialsDotGovTrialID>NCT34905834785<clinicalTrialsDotGovTrialID>NCT12345678</tns:clinicalTrialsDotGovTrialID>
    <tns:otherTrialID>934875<dcpIdentifier>DCP999999999999</tns:otherTrialID>dcpIdentifier>
    <tns:otherTrialID>CCR492384<otherTrialID>OTHER00000000001</tns:otherTrialID>
    <tns:title>A Phase I/II Study Ofof BrentuximabREST Vedotin In Combination With Multi-Agent Chemotherapy Amended<Trial Amendment</tns:title>
    <tns:phase>I</tns:title>phase>
    <tns:phase>NA<pilot>false</tns:phase>pilot>
    <tns:pilot>true<accrualDiseaseTerminology>SDC</tns:pilot>accrualDiseaseTerminology>
    <tns:accrualDiseaseTerminology>ICD-O-3<primaryPurpose>Other</tns:accrualDiseaseTerminology>primaryPurpose>
    <tns:primaryPurpose>Basic Science<primaryPurposeOtherDescription>Additional description of the trial's purpose</tns:primaryPurpose>primaryPurposeOtherDescription>
    <tns:interventionalDesign>
        <tns:secondaryPurpose>Ancillary-Correlative<:secondaryPurpose>Other</tns:secondaryPurpose>
        <tns:secondaryPurposeOtherDescription>Additional description of the trial's purpose</tns:secondaryPurpose>secondaryPurposeOtherDescription>
    </tns:interventionalDesign>
    <tns:leadOrganization>
		        <tns:existingOrganization>
			            <tns:poID>1</tns:poID>
		        </tns:existingOrganization>
    </tns:leadOrganization>
    <tns:pi>
		        <tns:existingPerson>
			            <tns:poID>1<poID>10</tns:poID>
		        </tns:existingPerson>
    </tns:pi>
    <tns:sponsor>
		        <tns:existingOrganization>
			            <tns:poID>2</tns:poID>
		        </tns:existingOrganization>
    </tns:sponsor>
    <tns:responsibleParty>
        <tns:type>Sponsor</tns:type>
    </tns:responsibleParty>
    <tns:summary4FundingSponsor>
		        <tns:existingOrganization>
			            <tns:poID>3</tns:poID>
		        </tns:existingOrganization>
    </tns:summary4FundingSponsor>
    <tns:programCode>PG00002</tns:programCode>
    <tns:fundedByNciGrant>false</tns:fundedByNciGrant>
    <tns:grant>
        <tns:fundingMechanism>C06<fundingMechanism>B01</tns:fundingMechanism>
        <tns:nihInstitutionCode>AG<nihInstitutionCode>AA</tns:nihInstitutionCode>
        <tns:serialNumber>343435<serialNumber>111111</tns:serialNumber>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:fundingPercentage>100.0</tns:fundingPercentage>
    </tns:grant>
    <tns:trialStatus>In Review</tns:trialStatus>
    <tns:whyStopped><whyStopped>If study stopped, enter the reason why.</tns:whyStopped>
    <tns:trialStatusDate>2014-07-15</tns:trialStatusDate>
    <tns:trialStartDate type="Actual">2014-07-15</tns:trialStartDate>
    <tns:primaryCompletionDate type="Anticipated">2016>2018-07-15</tns:primaryCompletionDate>
    <tns:completionDate type="Anticipated">2016>2018-07-15</tns:completionDate>
    <tns:ind>
        <tns:number>54554<number>111111</tns:number>
        <tns:grantor>CDER</tns:grantor>
        <tns:holderType>NIH</tns:holderType>
        <tns:nihInstitution>NEI</tns:nihInstitution>
        <tns:expandedAccess>true</tns:expandedAccess>nihInstitution>
        <tns:expandedAccessType>Available<expandedAccess>true</tns:expandedAccessType>expandedAccess>
        <tns:exempt>true<expandedAccessRecord>NCT12345688</tns:exempt>expandedAccessRecord>
    </tns:ind>
    <tns:ide>
        <tns:number>646456<number>222222</tns:number>
        <tns:grantor>CDRH</tns:grantor>
        <tns:holderType>NCI</tns:holderType>
        <tns:nciDivisionProgramCode>CCR</tns:nciDivisionProgramCode>
        <tns:expandedAccess>true<expandedAccess>unknown</tns:expandedAccess>
    </tns:ide>
    <tns:expandedAccessType>Available</tns:expandedAccessType>regulatoryInformation>
        <tns:exempt>true<fdaRegulatedDrug>true</tns:exempt>fdaRegulatedDrug>
       < <tns:fdaRegulatedDevice>true</tns:ide>fdaRegulatedDevice>
        <tns:approvalClearance>true</tns:regulatoryInformation>approvalClearance>
        <tns:country>USA<marketSurveillance>true</tns:country>marketSurveillance>
        <tns:authorityName>Food and Drug Administration<usaExport>true</tns:authorityName>usaExport>
        <tns:fdaRegulated>true</tns:fdaRegulated>
        <tns:section801>true</tns:section801>
        <tns:delayedPosting>true<delayedPosting>false</tns:delayedPosting>
        <tns:dataMonitoringCommitteeAppointed>false<dataMonitoringCommitteeAppointed>true</tns:dataMonitoringCommitteeAppointed>
    </tns:regulatoryInformation>
    <tns:protocolDocument filename="protocol_amend.pdf">dGVzdA==</tns:protocolDocument>
    <tns:irbApprovalDocument filename="irb_amend.pdf">dGVzdA==</tns:irbApprovalDocument>
    <tns:participatingSitesDocument
        filename="sites_amend.pdf">dGVzdA==</tns:participatingSitesDocument>
    <tns:informedConsentDocument filename="consent_amend.pdf">dGVzdA==</tns:informedConsentDocument>
    <tns:otherDocument filename="other_amend.pdf">dGVzdA==</tns:otherDocument>
    <tns:amendmentNumber>99</tns:amendmentNumber>
    <tns:amendmentDate>2014-08-01</tns:amendmentDate>
    <tns:ctepIdentifier>CTEP99999999999999<ctepIdentifier>CTEP99999999</tns:ctepIdentifier>
    <tns:dcpIdentifier>DCP9999999999999999</tns:dcpIdentifier>
    <tns:changeMemoDocument filename="memo.pdf">dGVzdA==</tns:changeMemoDocument>
    <tns:protocolHighlightDocument filename="high.pdf">dGVzdA==</tns:protocolHighlightDocument>
</tns:CompleteTrialAmendment>

Response:

Code Block
languagehtml/xml
collapsetrue
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<TrialRegistrationConfirmation xmlns="gov.nih.nci.pa.webservices.types"
    xmlns:ns2="gov.nih.nci.po.webservices.types.trimmed">
    <paTrialID>137908558</paTrialID>
    <nciTrialID>NCI-2014-00496</nciTrialID>
</TrialRegistrationConfirmation>