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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.
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