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Looking for a pediatric specialty clinic? Cook Children's has more than 60 locations across North Texas, because even when your child's diagnosis is complicated, finding the right care should be simple.
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Cook Children's Investigational Drug Services (IDS) coordinates all pharmacy processes and procedures for clinical research trials.
IDS keeps track of drugs used in clinical research trials. This includes managing drug inventory, storing the drugs, distributing the drugs and keeping records for all clinical trials. Each protocol is reviewed by the IDS pharmacist to make sure the trial is feasible, that budget needs will be met and to identify any IDS-related issues.
The IDS pharmacy includes a knowledgeable staff that is available 24 hours a day for medical center patients and emergencies. The IDS provides patients, investigators and sponsors the ability to conduct an organized and valid clinical trial that follows good clinical practice standards (GCP) and state and federal regulations.
The responsibilities for IDS include:
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.