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Investigational Drug Services

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:

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.