Pharmaceutical Management Branch (PMB)

The Pharmaceutical Management Branch (PMB) is charged with providing pharmaceutical support for clinical trials sponsored by the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP). This support includes:

• provision of pharmaceutical information about CTEP IND agents
  • Agent Management
  • Investigator Brochure (IB)
  • Material Safety Data Sheet (MSDS)
  • Patient/Caregiver Ad Hoc Education Template
• registration of all investigators and associates participating in CTEP clinical trials and the maintenance of all registration records
  • Person Registration (IAM)
  • NCI Registration and Credential Repository (RCR)
  • Registration Expiration Date
• a Treatment Referral Center (TRC) for handling special CTEP clinical agent initiatives, referrals to high priority clinical trials and the coordination, authorization, and processing of all requests for Special Exception and Treatment Referral Center protocol agent use
  • Treatment Referral Center and Non-Research Use of Investigational Agents
  • Non-Protocol Access to Experimental Agents
• authorization and distribution of all CTEP-sponsored Investigational New Drug (IND) agents to eligible investigators
• provision of agent forecasting, agent acquisition, and inventory management of all IND agents distributed by CTEP for clinical trials
• provision and management of high priority double blind, randomized clinical trials
• distribution of agents to investigators for non-human (preclinical) use
• CTEP Forms, Templates and Documents
• Drug Shortage Article