Registration Procedures and CTSU Website Access

Access to the CTSU members’ website allows staff at clinical institutions participating on NCI-supported trials to access several resources:

  • Protocol and protocol-related documents
  • Funding information for studies under the National Cancer Institute (NCI) National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP)
  • NCI Central Institutional Review Board (CIRB) documents for sites
  • Links to Medidata Rave® and the Oncology Patient Enrollment Network (OPEN)
  • Access to the Data Quality Portal, Delegation of Tasks Log, and accrual information
  • The Regulatory Submission Portal and associated information
  • Educational materials
  • E-mail notifications on protocol updates and CTSU-supported activities

Cancer Therapy Evaluation Program - Identity and Access Management (CTEP-IAM) and ID.me accounts are required to participate in NCI clinical trials. Investigators and clinical site staff contributing to research must register in the Registration and Credential Repository (RCR). The RCR is a self-service online person registration application with electronic signature and document submission capability. The RCR recognizes six types of registered users:

  • Investigators (IVR) – licensed MD, DO, or equivalent.
  • Non-Physician Investigators (NPIVR) - advanced practice clinical staff who may act as study principal investigators (PI), site-protocol PIs, or enrolling PIs in OPEN for select studies.
  • Non-Investigational New Drug/Non-Treatment (NINT) – Advance practice clinical staff who may act as study principal investigators (PI), site-protocol PIs, or enrolling PIs in OPEN for National Cancer Institute (NCI) funded NCORP cancer control (i.e., screening, prevention, symptom management) or cancer care delivery research that are non-treatment or if specifically directed by NCI or the trial’s Lead Organization to use this registration type. DO NOT select this registration type if any of the NCI funded trials you currently participate in or plan to participate in involves treating participants with drugs.
  • Associate Plus (AP) – clinical site staff integral to the conduct of NCI-supported studies (e.g., those registering patients in OPEN, managing data in Rave, maintaining Delegation of Tasks Logs, or serving as primary contacts on site rosters).
  • Associate (A) – other clinical or administrative staff that require access to NCI-supported applications but act in a supporting role (ordering designees, regulatory submissions, etc.).
  • Associate Basic (AB) – individuals that require limited access to select NCI-supported applications or are tracked for administrative purposes (e.g., industry contacts). ABs will not have access to the CTSU website.

NCI requires annual re-registration for all registration types. IVRs, NPIVRs, NINTs, and APs will re-register in RCR. Associates and ABs will re-register in IAM. You will receive an email from RCRRegistration@nih.gov at 60 and 30 days prior to re-registration. Failure to re-register will immediately suspend your CTEP status and remove your access to applications. IVRs, NPIVRs, and NINTs who fail to re-register within one year of their due date will be automatically withdrawn from all rosters. Associates and APs will be automatically withdrawn after six months. Please ensure that your Good Clinical Practice (GCP) training and licensure (if applicable) is up to date to streamline the re-registration process.

Resources and Links to Webpages

For information on the process linking CTEP-IAM with ID.me: https://ctep.cancer.gov/investigatorResources/NCI_CTEP_IAM_User_Access_Update.htm

To obtain or update IAM credentials, or to start the process of setting up your ID.me account, visit the IAM registration page: https://ctepcore.nci.nih.gov/iam

To register in the RCR, visit: https://ctepcore.nci.nih.gov/rcr

RCR Quick Reference Guide – Provides an overview of the CTEP-IAM and RCR registration process

Registration Checklists by Registration Type – Profile Checklists for IVRs, NPIRVRs, and APs of required RCR information

For help with RCR, contact the RCR Helpdesk: RCRHelpDesk@nih.gov

Additional information regarding registration is located on the CTEP registration page: https://ctep.cancer.gov/branches/pmb/associate_registration.htm




Post Date: 08-Oct-2024