Agent Management
For questions about AURORA or inventory management for CTEP IND agents, email CTEP's Pharmaceutical Management Branch at PMBAfterHours@mail.nih.gov.
Access to the AURORA application and CLASS training requires creation of a CTEP-IAM user account.
To receive important updates about PMB closures, updated Investigational Brochure postings, and more, subscribe to the PMB Listserv.
AURORA – CTEP's online inventory management system
Policy and Guidelines Documents
- Investigational Agent Distribution (PDF)
- Investigational Agent Ordering (PDF)
- Accountability and Storage of Investigational Agents (PDF)
- Investigational Agent Transfers (PDF)
- Investigational Agent Returns (PDF)
- Investigational Agent Local Destruction (PDF)
- Shipping Oral IND Agents to Clinical Trials Subjects (PDF)
- Advance Practice Providers Writing Study Agent Orders (PDF)
Investigator Brochures (IBs)
For CTEP-IND agents distributed by PMB, current versions of the Investigator Brochures (IBs) and related IB documents (Summary Of Changes documents, Appendices, Addenda, Errata) are provided through the AURORA application.
When new IB documents are posted in AURORA, email notifications are sent to all study PIs, site PIs, study grant PIs, investigators who received agent shipments or transfers, designated CTEP site coordinators, and designated PMB contacts at CIRB and at network operations offices.
Questions regarding investigator brochures can be directed to the Pharmaceutical Management Branch (PMB), CTEP, NCI by calling (240) 276-6575 Monday through Friday from 8:30am to 4:30pm Eastern Time or by emailing ibcoordinator@mail.nih.gov at any time.
Agent Accountability Forms
2016 DARF Training Videos and Slide Handouts