Services

ONC IDS pharmacy plays a crucial role in supporting oncology clinical research by ensuring the safe and compliant handling of investigational products.

ONC IDS provides investigational drug services for many of the oncology clinical research units including Brain Tumor Center, Breast Cancer, Gastrointestinal, Genitourinary, Gynecology Oncology, Head and Neck, Melanoma, Sarcoma, Thoracic Cancer, Bone Marrow Transplant, Cell Therapy, Hematology, Multiple Myeloma, Myeloproliferative Neoplasm, Immunotherapy, Pediatrics, Phase 1, as well as other groups at Duke including Radiation Oncology, Surgical Oncology, and Urology. 

Investigational products are procured, stored, inventoried, dispensed and used through ONC IDS in compliance with applicable federal, state, local and institutional laws, regulations, policies and guidelines. 

Services provided for all research protocols:

  • Maintain investigational drugs for oncology clinical trials
  • Protocol review and monitoring committee review
  • Provide drug information for research protocols (e.g., drug preparation information, drug-drug interactions) 
  • Build, validate, and update ERx builds for new protocols and amendments including research protocols, Expanded Access Programs, and single patient Investigational New Drug (INDs) 
  • Create clinical assessment and monitoring parameters for all research beacon plans
  • Validate research beacon plans for new protocols and amendments  
  • Compose pharmacy summaries for parenteral agents 
  • Attend DOCR start-up meetings and review pharmacy related calendar items 
  • Site Initiation Visits (SIVs) to ensure all pharmacy information on protocols is obtained 
  • Manage investigational drug accountability through Vestigo  
  • Prepare > 70% of all oncology investigational drug preparations
  • Host virtual monitoring visits for sponsors
  • Receive investigational drug shipments
  • Train on all ONC IDS-involved protocols
  • Perform drug return accountability on oral medication

Services provided based on study-related activities:

  • Review labs for patients on clinical trials prior to dispensing
  • Review concomitant medications for potential patients on clinical trials
  • Order investigational drugs 
  • Send out investigational drugs to satellite pharmacies
  • Educate inpatient pharmacy staff on research studies requiring observed dose escalation/safety monitoring

Additional services provided:

  • Train pharmacy staff at satellite sites on Vestigo use
  • Pharmacy Manual creation consultation for investigator-initiated studies
  • Assisting research team members with nursing in-service education
  • Drug pricing for investigator-initiated studies only