NCI CTRP Trial Registration REST Service Guide

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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.

Program Codes

The program codes feature (not to be confused with NCI Division and Program Codes) 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

STAGE: https://trials-stage.nci.nih.gov/services
PROD: https://trials.nci.nih.gov/services

Access Requirements

To use the service, you must have a valid NCI LDAP account and a 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. 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. CTRP does not manage information about persons and organizations; instead, this is delegated to the Person and Organization Curation Portal, also known as PO. See the Person and Organization Curation Portal User's Guide for more information.

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

Before registering a trial, ensure that organizations and persons acting on the trial exist already in PO. 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.

Use 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. 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 Abbreviated Trial

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

HTTP Method	POST
URL	/trials/abbreviated/{nct} Parameters {nct}. ClinicalTrials.gov Trial Identifier
Request Body	Empty
Response Body	XML 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 trial with the given identifier already exists 500. Internal server error
Examples	URL: https://trials.nci.nih.gov/services/trials/abbreviated/NCT02208700 Response: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException'

Update an Abbreviated Trial

Request to update an Abbreviated trial in CTRP.

HTTP Method	POST
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 Body	XML document with AbbreviatedTrialUpdate MIME Type: `application/xml`
Response Body	XML 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.nci.nih.gov/services/trials/abbreviated/nci/NCI-2014-00496 Request: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Response: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException'

Register a Complete Trial

Request to register a Complete trial in CTRP.

HTTP Method	POST
URL	/trials/complete
Request Body	XML document with CompleteTrialRegistration MIME Type: `application/xml`
Response Body	XML 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.nci.nih.gov/services/trials/complete Request (referring to existing Organizations and Persons by ID): Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Request (non-interventional trial): Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Request (trial where submission to ClinicalTrials.gov is not required): Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Request (trial with minimum data): Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Request (trial where responsible party is Sponsor-Investigator): Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Response: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException'

Update a Complete Trial

Request to update a Complete trial in CTRP.

HTTP Method	POST
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 Body	XML document with CompleteTrialUpdate MIME Type: `application/xml`
Response Body	XML 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.nci.nih.gov/services/trials/complete/nci/NCI-2014-00496 Request: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Response: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException'

Amend a Complete Trial

Request to amend a Complete trial in CTRP.

HTTP Method	PUT
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 Body	XML document with CompleteTrialAmendment MIME Type: `application/xml`
Response Body	XML 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.nci.nih.gov/services/trials/complete/nci/NCI-2014-00496 Request: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException' Response: Error rendering macro 'code': Invalid value specified for parameter 'com.atlassian.confluence.ext.code.render.InvalidValueException'

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