NCI Registration

All individuals involved in the conduct of NCI-supported trials are required to register annually in the NCI's Registration and Credential Repository (RCR).

All PIs and sub-investigators conducting research under HCC must maintain an active NCI registration. ODQ provides NCI registration support to all HCC physician investigators.

Important change to the log-in process for all NCI systems:

To ensure the security and safety of National Cancer Institute (NCI) systems, subjects, research staff, and all associated sensitive information, NCI has now incorporated Identity Verification/Proofing (IP) and Multi-Factor Authentication (MFA) into systems access through a platform called ID.me. This next generation of technology and techniques is required to protect user credentials accessing systems with confidential information in accordance with the Federal Information Security Management Act (FISMA).

New CTEP-IAM users should review: New CTEP-IAM user creating a new ID.me account- training video and transcript.

Existing CTEP users should review: Existing CTEP-IAM user creating a new ID.me account- training video and transcript OR Existing CTEP-IAM user linking existing ID.me account- training video and transcript for detailed instructions.

HCC NCI Registration Guide Contact the HCC Registration Coordinators (Physician-Investigators Only)

Resources

NCI - RCR Online Help ManualLink
Create a CTEP IAM AccountLink
Log in to RCRLink

NCI policy requires all persons participating in any NCI-sponsored clinical trial to register and renew their registration annually under the appropriate Registration Type. Individuals requiring write access to CTSU systems (including OPEN, RAVE, RUMS and TRIAD) must hold a Registration Type of IVR, NPIVR, or AP. Individuals holding a primary site role (e.g., Site Administrator, Data Administrator, LAPS Administrator, NCORP administrator) will require a minimum AP Registration Type.
Read more here.
If you are not a Physician-Investigator, we recommend carefully reviewing the RCR Online Help Manual for detailed information on how to register under your specific Registration Type. If you are a Physician-Investigator or a staff member assisting a Physician-Investigator with registration, please review our HCC NCI Registration Guide, and contact us at ODQEducation@dfci.harvard.edu for more direct support. Note that this guide may be helpful to other registration types as well.
A CTEP-IAM account is required to access CTEP applications, including the RCR platform. To request a new CTEP IAM account, follow the steps outlined in the NCI's guide: New CTEP-IAM user creating a new ID.me account- training video and transcript.
If you are a physician-investigator and you are unsure if you have an existing CTEP-IAM account or need to request a new one, please contact us at ODQEducation@dfci.harvard.edu.

All individuals will need to have a CTEP IAM account in order to register in RCR. Additional registration requirements depend on an individual's role.

Registration Type	Registration Requirements	Comments
Investigator (IVR)	Electronic annual registration using RCR FDA Form 1572 Financial Disclosure Form NCI Biosketch Agent Shipment Form (if applicable) Good Clinical Practice Training Certificate Optional CV	Individuals requiring write access to CTSU systems must hold a Registration Type of IVR, NPIVR, or AP. Individuals holding a primary site role (e.g., Site Administrator, Data Administrator, LAPS Administrator, NCORP administrator) will require a minimum AP Registration Type.
Non-Physician Investigator (NPIVR)	Electronic annual registration using RCR FDA Form 1572 Financial Disclosure Form NCI Biosketch Good Clinical Practice Training Certificate Optional CV
Associate Plus (AP)	Electronic annual registration using RCR Financial Disclosure Form NCI Biosketch Good Clinical Practice Training Certificate Optional CV
Associate (A)	Electronic annual registration using IAM	May access CTSU website and systems including view access to OPEN and RAVE
Associate Basic (AB)	Electronic annual registration using IAM	For individuals who are required to register but cannot be granted systems access

Per the NCI: "The NCI maintains the complete RCR profile (i.e., 1572, NCI Biosketch, FDF, ASF) for registered users in our central database and sites are not expected to have a duplicate file on site as it may not reflect the complete or current information in RCR. This process has been discussed and developed in collaboration with the FDA and found to be acceptable. In the event of a FDA audit, NCI can provide a study-specific report upon direct request from the auditor. If this is requested during an audit, please provide the FDA request via email (GeneralQuestionsforCTMB@nih.gov) with the contact information for the auditor so we can provide directly to the auditor."

What is a Registration Coordinator (RC)?

A Registration Coordinator (RC) can assist someone who needs to register in RCR by updating registration entries on behalf of the profile owner.

The RC can view and update all registration documents for the profile owner (except the Financial Disclosure Form [FDF]) but cannot sign or submit the documents as this must be completed by each individual person registering with the NCI. The RC can send notifications through the RCR system alerting the profile owner that their documents are ready for signature and submission.

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Who is my Registration Coordinator (RC)?

Physicians: The Office of Data Quality provides centralized registration support to all HCC physician investigators (IVR role). If you are a HCC physician, please contact ODQEducation@dfci.harvard.edu for assistance in completing or updating your annual registration.

Non-physicians (NP-IVR and AP roles) should reach out to their research manager and/or clinical trials office to determine whether they have a registration coordinator. All roles may also follow the HCC Step-by-Step Guide: How to Register in RCR for additional role-based guidance on completing the registration process.

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How does one become a Registration Coordinator?

Requests to become a registration coordinator must be sent via email to the CTEP REGHELP mailbox.

Email: CTEP REGHELP (ctepreghelp@mail.nih.gov).

Email Subject: Make Me a Registration Coordinator

Please include the following in your request:

Institution Name and ID number: For example [MGH=MA034, DFCI=MA036, BIDMC (MA038)]
Name of Person who will be the RC (ID number if known)
Name of Back-up RC (if applicable)
List of Profiles to be linked to

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Resources for RCs

NCI - RCR Online Help ManualLink