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 until January 2024 to incorporate an ID.me account.
Registration in the Registration and Credentialing Repository (RCR), a self-service online person registration application with electronic signature and document submission capability, is also necessary for most staff. The RCR recognizes five 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.
- Associate Plus (AP) – clinical site staff integral to the conduct of NCI-supported studies.
- 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.
Food and Drug Administration (FDA) regulations and NCI policy require all investigators (IVRs and NPIVRs) participating in any NCI-sponsored clinical trial to register and to renew their registration annually.
Investigator registration will be completed in the RCR and requires electronic submission of:
- FDA Form 1572 or International Investigator Statement
- Financial Disclosure Form
- NCI Biosketch
- Agent Shipment Form (if applicable)
- Human Subjects Protection
- Good Clinical Practices
- Optional Curriculum Vitae (CV)
APs must complete an annual registration in RCR and electronically submit a Financial Disclosure Form, NCI Biosketch, Human Subjects Protection, Good Clinical Practice, and Optional CV.
Associates and ABs will perform annual registration using IAM. Associates may access the CTSU website and systems including view access to OPEN and Rave. As noted previously, ABs may not access the CTSU website or systems.
Resources and Links to Webpages
For information on the implementation of the 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
Introduction to CTEP’s Registration and Credential Repository (RCR) Slide Set (August 28, 2017)
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: 19-Apr-2023