Research pharmacists and technicians play a fundamental role in clinical trials involving investigational drugs. Contacting the IDS in the beginning stage of a study can help streamline the process effectively.

Initiating an investigational drug study

Email the study protocol to the clinical research budget analysts.

IRB submission assistance

Email the IDS before IRB submission. The most efficient way the IDS can provide this assistance is for you to email your protocol to the clinical research budget analysts.

Help with study budgets

The IDS will provide a budget to perform required tasks. To obtain a budget, email your protocol to the clinical research budget analysts.

Fee Structure

Fees are based on the type of services provided. For site pharmacy tasks, IDS core fees are broken out into the following:

Administrative fee

Covers:

  • Protocol review and IRB protocol/application information
  • Initial site training as required by sponsor (SIV)
  • Meetings in which IDS staff and Seattle Children's research staff decide on internal procedures
  • Time to set up written procedures necessary for safe and efficient drug ordering, receiving, storage, compounding and distribution
  • Creation and maintenance of a blind, if necessary
  • Time to set up a study binder with procedure and accountability sections and the protocol
  • Creating study information sheets and research medication orders
  • Time to meet with clinical research associates (study monitors) and funding agency research personnel prior to and at study initiation
  • Setting up a pharmacy staff in-service for each new study and presenting part of the in-service
  • Staff attendance at any offsite/out-of-town meetings as required (funding for travel and time is required)
  • Inventory control and temperature-monitoring systems
  • Study close-out activities
  • Destruction of investigational product as needed
  • Archival of research pharmacy documents

Dispensing fees

Cover:

  • Time for the IDS staff to order, receive and stock the investigational product
  • Time for a pharmacist to review the order, check the investigational product and provide medication teaching to the subject and/or family
  • Handling and preparing investigational product by a technician
  • Use of disposable and non-disposable pharmacy equipment/supplies not provided by the study sponsor

Maintenance fee

Covers: 

  • Storing and maintaining investigational study product inventory (ordering, receiving, IWRS, quarterly inventory)
  • Completing accountability records and other regulatory paperwork
  • Ordering supplies 
  • Monitoring visits and audits
  • Protocol amendments and associated training