Investigational Drug Service
The Investigational Drug Service (IDS), supported by the Center for Clinical and Translational Research, is a licensed pharmacy that provides support and guidance for the safe and efficient conduct of clinical drug trials. Staffed by research pharmacists and technicians who are specially trained in the research process, we ensure the delivery of high-quality pharmaceutical care by adhering to federal and state regulations, accreditation standards and institutional policies for investigational drug control.
In addition to providing investigational site pharmacy services, the IDS is experienced with providing coordinating pharmacy services for multicenter trials. The following services are offered upon request:
- Study design and protocol development assistance
- Dispensing and destroying study drugs or returning study drugs to sponsors
- Randomization and development of blinding systems and placebos
- Labeling and packaging of investigational products
- Multisite drug distribution and monitoring
- Freezer and refrigerator space that is monitored and alarmed to ensure proper storage conditions
- FDA IND application development assistance
- IRB submission and study budget assistance
- Concomitant medication coding (using WHO Drug Dictionary)
Help prior to IRB submission
If you are an investigator or study coordinator preparing to submit your study to the Institutional Review Board (IRB), please contact the IDS before IRB submission. IDS staff can help ensure the services you need can be provided.
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
If you are an investigator or study coordinator, the DS will provide you with a budget to perform required tasks. To obtain a budget, email your protocol to the clinical research budget analysts.
Location and Hours
The IDS core is located in the Mountain Pharmacy at Seattle Children’s hospital campus. Core staff are available from 8 a.m. to 4:30 p.m., Monday through Friday, and research pharmacists are available after hours by pager for urgent issues.