COMPOSITION / STRUCTURE

Coordinators:

Javier Bécares Martínez (Head of service / Specialist in hospital pharmacy)

Macarena Bonilla Porras (Coordinator / Specialist in hospital pharmacy)

ROLE

  • Involvement in clinical research ethics committees
    • Javier Bécares: Member of the Madrid region ethics committee and the IIS-FJD ethics committee.
    • Macarena Bonilla: Vice president of the IIS-FJD ethics committee.
  • Management of samples used in clinical research.

Medicines used in clinical research must be distributed through the hospital pharmacology services. The service is charged with safekeeping and dispensing of medicines.

The pharmacology service has the means necessary to guarantee compliance with SOPs as concerns storage, handling and logging of outgoing samples for clinical research and their return (samples are kept separate from all other pharmaceutical products). Access to the Clinical Trials Area is restricted. It contains the following equipment:

  • Closet (with restricted access) for storage of pharmaceuticals used for clinical research (kept at room temperature)
  • 2 refrigerators (restricted access)
  • 1 freezer

Spaces kept at room temperature are monitored on a daily basis using a digital thermometer to log minimum and maximum temperatures. An automatic temperature-control system continuously logs refrigerator temperatures. Alarm systems warn of deviations.

Standardized procedures are in place to insure safety in the clinical-trials process (e.g., patient identification, sample identification).

The following trial-related activities are also carried out:

  • Handling of samples and databases (IVRS, IWRS, Clinphone, ALMAC, ICON, PPD, and Perceptives)
  • Oversight visits
  • Sample handling and preparation
  • Accounting forms and outgoing-sample logs
  • Re-labeling
  • Management of expiration dates
  • Destruction of samples

A pharmacist is available from 8:00 am to 10:00 pm from Monday to Friday and from 9:00 am to 3:00 pm on Saturdays.