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 including:

  • Protocol and protocol-related documents
  • Funding information for studies under the National Cancer Institute (NCI) National Clinical Trials Network (NCTN)
  • 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, Site Audit 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

Access is managed through the Cancer Therapy Evaluation Program - Identity and Access Management (CTEP-IAM) registration system and ID.me (which incorporates Identity Proofing (IP) and Multi-Factor Authentication (MFA) into the registration process). As of July 8, 2022, all new users must have an active CTEP-IAM account linked with an ID.me account to access the CTSU website. All existing users who had CTEP-IAM accounts prior to July 8, 2022, have a target date of January 2024 incorporate an ID.me account. An absolute deadline for onboarding to ID.me (after which it will be required for access to applications) will be shared once established by NCI.

Registration in the Registration and Credentialing Repository (RCR) is also necessary for most staff. 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) – Investigators (e.g., MD, DO, PhD) who wish to participate exclusively in non-IND/non-treatment studies.
  • 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

[New] For information on the implementation (starting July 8, 2022) of a new user access 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 and MFA (required to access the CTSU website and all other CTEP applications), 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: 09-Jan-2024