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Investigational Drug Services Pharmacy

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.

Protocol reviews

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.

Protocol implementation

Once Cook Children's approves the protocol, the IDS pharmacist prepares for the research trial in the pharmacy.

The process includes:

  • Creating a research study binder to hold study-related documents.
  • Making drug data sheets for investigational agents used as educational material for Cook Children's staff.
  • Developing physician order sets for the trial.
  • Developing protocol-specific pharmacy procedures for drug storage, handling and preparation.
  • Developing pharmacy staff protocol education and training materials.

Drug storage, dispensing and record keeping.

  • Limited access storage of investigational agents are kept separate from bulk pharmacy stock.
  • Refrigerator, freezer and locked controlled substance storage of investigational agents.
  • Controlled temperature monitoring on all areas storing investigational agents.
  • Inpatient and outpatient dispensing that complies with all state and federal regulations.
  • Documentation of subject-specific and overall site accountability of all dispensed investigational agents.
  • Preparation and accommodations for site selection visits, site initiation visits, routine monitoring visits, internal and external audits and study close-out visits.

Drug information/patient counseling

The IDS pharmacist will provide patient counseling on all initial prescriptions for investigational agents, when possible.

Inventory control

The IDS pharmacy and research staff is responsible for ordering, receiving, expiration tracking and documentation of all investigational drug shipments.

IDS quality assurance

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.

  • Routine monitoring of drug accountability records and reconciliation prior to ordering of new drug supply.
  • IDS numbering system to ensure the correct drug is used for each study. Every protocol is assigned a study number which is then affixed to the study binder and to the storage bin containing the study drug. This process was developed to simplify and streamline the process of dispensing the appropriate investigational medication for the study.

Compliance

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.

For parents

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.

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