Pharmaceutical Management Branch, CTEP Inventory Management System: AURORA

AURORA is the NCI's innovative and centralized agent inventory management system. AURORA will replace OAOP for the electronic submission of agent order requests for NCI sponsored trials, review of agent order request status, and access to PMB provided documents (e.g., agent stock recovery notices, Investigator Brochures, and Material Safety Data Sheets). In addition, AURORA will allow sites to create and maintain Primary Shipping Designee shipping addresses and Primary Ordering Designees, and electronic NCI Investigational Agent (Drug) Accountability Records (eDARF) and associated inventory management practices. The system, in combination with other NCI Clinical Oncology Research Enterprise (CORE) applications, will provide consistent record-keeping processes and oversight across all clinical trial sites, improve sponsor and site compliance with regulatory requirements and streamline sponsor and site communications for NCI sponsored trials.

Please refer to the AURORA implementation plan FAQ for information on compliance timelines for NCI sponsored trials. Access to AURORA requires the establishment of a CTEP Identity and Access Management (IAM) account and the maintenance of an "active" account status, a "current" password and active person registration status. AURORA enables you to perform one or more of the following operations based on your account access role:

• Agent Ordering
  • Create orders, view order status, modify orders, respond to PMB queries, and view shipment tracking information.
• Document Access
  • Access stock notification letters, Investigator Brochures, and Material Safety Data Sheets of CTEP-IND agents.
• Primary Shipping Designee Worksheet
  • Maintain the shipping addresses and ordering designees of all linked investigators.
• Agent Accountability
  • Set up control and satellite dispensing areas and add satellite designees in the Site Maintenance module.
  • Complete transactions such as agent receipt, adjustment, dispensing, inventory verification, local destructions, and transfers in the eDARF module.

*Only investigators serving as a primary shipping designee have the ability to create new PSD records and submit updates to current PSD records.

AURORA Function	Primary Shipping Designees	Primary Ordering Designees	Control site-assigned Satellite Designees	Investigators	All Other Users
Agent Ordering	✔	✔		✔
Document Access - IB	✔	✔	✔	✔	✔
Document Access - MSDS, stock recovery	✔	✔		✔
View PSD worksheet	✔	✔		✔
Create and Edit PSD worksheet	✔			✔*
Agent Accountability	✔ Control Dispensing Area and Satellite Dispensing Area records	✔ Control Dispensing Area and Satellite Dispensing Area records	✔ Satellite Dispensing Area records only	✔

• Training and Resources
  • AURORA Overview Presentation and Slides
    1. Webex meeting recording: AURORA Overview Training-20220706
    2. Powerpoint slides [pdf]
  • AURORA Training Videos
    
    NCI/CTEP AURORA Training course in the CLASS Learning Management System demonstrates functions within AURORA. Access to CLASS requires the establishment of a CTEP Identity and Access Management (IAM) account and the maintenance of an "active" account status, a "current" password and active person registration status.
    
    Enroll in the "NCI/CTEP AURORA Training" course within CLASS by:
    1. Using this link (www.ctsu.org/Public/class.aspx?courseid=778fd651-c326-4591-b8ab-7c02c2c57054) to access and enroll in the course directly, or
    2. Log in to CLASS Learning Management System and locate the NCI/CTEP Aurora Training course in the catalog and self-enroll from there.
  • AURORA FAQs
  • Help button on AURORA dashboard provides step-by-step help
  • For issues related to AURORA, please contact PMBAfterHours@mail.nih.gov