The Investigational Drug Service tracks and stores study drugs, assists investigators with drug-related aspects of study design and protocol development and provides technical consultation on drugs used in single-site and multicenter clinical trials.
The Investigational Drug Service (IDS), supported by the Center for Clinical and Translational Research, is a licensed pharmacy that dispenses medications used in inpatient and ambulatory clinical trials performed by investigators at Seattle Children’s.
The IDS sets up study-drug-related procedures and systems for each study to ensure patient safety, protocol adherence and compliance with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs) and other regulations and laws.
Services
The services provided by IDS research pharmacists and research pharmacy associates include tracking and storing study drugs, assisting investigators with drug-related aspects of study design and protocol development and providing technical consultation on drugs used in single-site and multicenter clinical trials.
The following IDS services are offered to investigators upon request:
- Overseeing special procedures for investigational drugs
- Overseeing protocol-driven procedures
- Receiving, storing, labeling and tracking inventory
- Dispensing study drugs
- Destroying study drugs or returning study drugs to sponsors
- Aiding investigators in study design and protocol development
- Compounding blinded study drugs for selected investigator-initiated clinical trials
- Relabeling and repackaging study drugs to meet study protocol requirements with investigator-initiated trials
- Distributing study drugs to other study sites in some cases
- Providing consulting services on GMP and regulatory issues
IDS Can Provide 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 IDS can provide this assistance is for you to e-mail your protocol to the clinical research budget analysts.
IDS Can Provide Help with Study Budgets
If you are an investigator or study coordinator, the IDS will provide you with a budget to perform required tasks. To obtain a budget, e-mail your protocol to the clinical research budget analysts.
Location and Hours
The IDS core is located in the Rocket (Inpatient) Pharmacy of Seattle Children's Hospital's main 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.