Resources for Research Site Pharmacists

NCI CTEP Pharmaceutical Management Branch (PMB):

• CTEP Pharmaceutical Management Branch (PMB)
  • Subscribe to the PMB Listserv to receive email alerts regarding updates to investigator brochures, PMB office closures, or other important news. 
• CTEP Agent Management 
  • Policies and Guideline Documents (Agent Ordering, Transfers, and Accountability)
    • NCI Agent Accountability, Transfer and Return Forms​
    • Shipping Oral IND Agents to Clinical Trial Participants
  • CTEP PMB Agent Inventory Management System: AURORA
    • AURORA Training in CLASS
    • AURORA FAQs
  • Investigator Brochures (IB) for protocols with CTEP-held IND 
    • AURORA Document Access (including IBs) Training Video in CLASS
  • Drug Accountability Record Forms (DARF) Educational Materials
• PMB Contact Information

SWOG Protocol and Safety Resources

• SWOG Investigational Agent Audit Checklist
• SWOG Biosimilars Guidelines
• Handout for Trial Participants Receiving Investigational Oral Chemotherapy
• NCI Cancer Therapy Evaluation Program (CTEP) Trial Development Resources
  • CTCAE Versions
  • Agent (NSC) Codes
  • Patient Drug Interactions Handout and Wallet Card
  • Tables of Possible Side Effects in Commonly Used Drugs (for CTEP Informed Consent Documents)
  • CTEP Agent Agreements
• NCI Clinical Trials Monitoring Branch Audit Guidelines 

Relevant SWOG Policies

The following SWOG Policies pertain to protocol guidelines, serious adverse events, drug ordering, HIPAA regulations, and allowances for research dose calculations and modifications. 

• Policy 13
• Policy 23
• Policy 25
• Policy 31
• Policy 38

SWOG Investigational Agent Handling Training Course

• Investigational Agent Handling (login with ID.me credentials used to access NCI systems)