October 14 2025
Written by Pamela J. Mason, RN, BSN, CCRP, Clinical Trials Coordinator, FirstHealth of the Carolinas; Mary Gulzow, CCRP, Clinical Research Specialist, CORA NCORP; NRG Quality Control and Communications Sub-Committee
The Regulatory and Credential Repository (RCR) is an online repository for some regulatory required documents for investigators and site staff participating in research supported by the National Cancer Institute (NCI). Individuals participating in NCI funded research who fill one of the defined registration types per RCR (Overview: NCI Registration Types) are required to submit the required documents for initial registration. Once the initial RCR registration has been completed, there is an annual renewal allowing participants to update information. A CTEP-IAM ID is required before the initial registration.
This process ensures that key components such as education, license, site affiliation, and roles remain current.
Aurora is the investigational agent inventory management system utilized by the NCI. Access to Aurora applications is defined by the user’s registration type and include the following functionalities on the dashboard and tool bar within the system. Online training for the Aurora application is available on the CTSU website in the CLASS tab.
- Agent Ordering and shipment tracking
- Document Access
- Stock Notifications
- Investigator Brochures
- Material Safety Data Sheets for CTEP-IND agents
- Primary Shipping Designee Worksheet
- Site addresses
- Primary Ordering & Shipping Designees
- Site Maintenance
- Designate Satellite Sites
- Agent Accountability for CTEP-IND agents
- Upload Supporting Documents
- Correspondence with PMB
- Site Auditing
Aurora and RCR integrate with multiple NCI Applications. Therefore, maintaining regulatory documents in the RCR repository, promotes a streamlined workflow for sites. An example is the process of linking the investigator’s FDA 1572 with the practice site in RCR, which enables the user to choose the enrolling investigator in the Oncology Patient Enrollment Network (OPEN). In contrast, if a user has not been validated in the RCR repository annually, that user will not be available in the dropdown menu at the time of enrollment in OPEN.