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CTRPdoc:NCI CTRP Trial Registration REST Service Guide - Include 20210125
CTRPdoc:NCI CTRP Trial Registration REST Service Guide - Include 20210125

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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
title 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

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Inside the NIH Firewall (VPN required)

Outside of the NIH Firewall

Access Requirements

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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

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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

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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.

Note
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.

Tip
title 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.

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/trials/abbreviated/{nct}

Parameters

{nct}. ClinicalTrials.gov Trial Identifier

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TrialRegistrationConfirmation

 

MIME Type: application/xml

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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

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

Response:

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Update an Abbreviated Trial

Request to update an Abbreviated trial in CTRP.

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/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.

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AbbreviatedTrialUpdate

MIME Type: application/xml

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TrialRegistrationConfirmation

MIME Type: application/xml

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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

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

Request:

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Response:

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Register a Complete Trial

Request to register a Complete trial in CTRP.

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CompleteTrialRegistration

MIME Type: application/xml

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TrialRegistrationConfirmation

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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

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

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

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Request (non-interventional trial):

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Request (trial where submission to ClinicalTrials.gov is not required):

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Request (trial with minimum data):

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

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Response:

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Update a Complete Trial

Request to update a Complete trial in CTRP.

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/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.

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CompleteTrialUpdate

MIME Type: application/xml

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TrialRegistrationConfirmation

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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

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

Request:

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Response:

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Amend a Complete Trial

Request to amend a Complete trial in CTRP.

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/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.

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CompleteTrialAmendment

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TrialRegistrationConfirmation

MIME Type: application/xml

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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

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

Request:

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Response:

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