Pharmaceutical Management Branch (PMB) AURORA Updates

September 14 2023

Writtenby Kayla Dye, PharmD, Senior Clinical ResearchPharmacist, CTEP/PMB/DCTD/NCI

AURORA is the NCI’s innovative and centralized agent inventory management system. Most of the modules within AURORA launched in January 2023 and have successfully been used by thousands of clinical trial sites since the launch. Gaining access to AURORA requires users to obtain credentials required for access to secure NCI Clinical Oncology Research Enterprise (CORE) systems. Access to certain modules within AURORA is based on your user role determined by your clinical trial site.

Current modules available to clinical trial sites include:

  • Agent ordering and review of order status
  • Access to PMB provided documents
  • Creation and Editing of PSD (Primary Shipping Designee) packets
  • Enhanced communication with PMB
  • Creation and maintenance of electronic NCI Investigational Agent (Drug) Accountability Records (eDARF)
  • Integration with other electronic accountability systems

Placing orders for PMB supplied agents is straightforward. Users can review the status of submitted orders in real time.

PMB provided documents including investigator brochures, stock recovery letters and MSDS documents are now available for download in one location. All AURORA users can access IB documents on behalf of their authorized site clinical investigators. Investigators, shipping designees and ordering designees have access to all these documents.

New and improved with AURORA, sites can quickly and easily update their PSD packet with new shipping addresses and add or remove ordering designees. Investigators may also be associated with more than one shipping address location in RCR based on their practice sites identified on the FDA Form 1572. Sites have the capability of selecting from multiple shipping addresses for an investigator when submitting order requests in AURORA.

AURORA offers a new way to easily communicate with PMB using the dialog function. The dialog function can be used to send a message directly to PMB. Responses are easily viewed in the notifications dashboard card. After sending a message, don’t forget to log back into AURORA to check for a response from PMB.

Future modules and enhancements in progress include:

The accountability module will include all the standard accountability functions clinical trial sites would expect but will also include several enhancements such as: ability to perform local destruction of NCI supplied agents versus returning agents to the NCI Clinical Repository, automatic population of agent expiration dates on the eDARF once PMB issues a stock recovery notice, flexibility to record patient agent returns on the eDARF and document patient return agent destruction, and enhanced record keeping with the elimination of paper accountability records.

The launch date for the accountability module has not yet been determined. PMB will communicate the launch date to sites as soon as possible. Sites currently using other electronic accountability systems will not be required to transition to the AURORA eDARF initially. The expectation is sites that are using paper DARFs will begin to transition as soon as the eDARF module is available.

AURORA integration with other electronic accountability systems is currently being explored. PMB will provide updates regarding future integration once updates are available.

PMB has created several resources to help clinical trial sites while using AURORA including: several self-paced AURORA training videos available in CLASS which will become mandatory for system access and some date in the future, comprehensive AURORA overview video and slides and AURORA FAQs on the PMB website. Make sure to check the PMB website and subscribe to the PMB listserv at for the most up to date AURORA information.

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