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Cook Children's investigational drug services (IDS) pharmacy coordinates all pharmacy processes and coordinates the use of drugs in research clinical trials. There are several steps to make sure that protocols are met and regulations are followed.
All protocols with a pharmacotherapy component are reviewed by the IDS pharmacist to see if there are any IDS- related issues, as well as feasibility and budget requirements. This review includes looking at implementation requirements, how the drug will be prepared and given to research participants and the potential costs associated with the study.
Once Cook Children's approves the protocol, the IDS pharmacist prepares for the research trial in the pharmacy.
The process includes:
The IDS pharmacist will provide patient counseling on all initial prescriptions for investigational agents, when possible.
The IDS pharmacy and research staff is responsible for ordering, receiving, expiration tracking and documentation of all investigational drug shipments.
The IDS is responsible for the integrity of drug management for all clinical trials within the Cook Children's system. The following measures have been developed to ensure proper conduct is followed.
Compliance with protocol and regulatory agencies is a strict requirement. The IDS pharmacist makes sure Cook Children's follows state and federal regulations including CFR title 21, Health Insurance Portability and Accountability Act (HIPPA), Joint Commission on Accreditation of Health Care Organizations (JCAHCO) and the state board of pharmacy.
Are you a parent who has questions about how the IDS pharmacy works and how research trial medicine is handled and given to the children taking part in the research? You'll find answers on our Investigational Drug Services FAQs page.
Find answers here