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 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.
Fees are based on the type of services provided. For site pharmacy tasks, IDS core fees are broken out into the following:
IDS administrative fee
- Protocol review and IRB protocol/application information
- 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-drug notebook with a procedure section, accountability section and the protocol
- Assistance in creating drug information sheets and medication order forms
- Time to meet with clinical research associates (study monitors) and funding agency research personnel prior to study initiation, at study initiation, during the study and to close out the study
- Setting up a pharmacy staff inservice for each new study and presenting part of the inservice
- Staff attendance at any off-site/out-of-town meetings as required (funding for travel and time is required)
- Inventory control and temperature-monitoring systems
- Time for the IDS staff to order, receive and stock the study drug
- Time for a pharmacist to review the order, check the study medication and educate the subject and/or family
- Technician time for preparing medication
- Delivery time
- Use of disposable and nondisposable pharmacy equipment not provided by the study
- Cost of any medications not provided by the study that the study is funding
- Periodic monitoring of study medication stock and accountability records
Fee structure is based on protocol requirements.