Pharmacy Service – Clinical Trials Unit

Developed by: Instituto de Investigación Sanitaria Fundación Jiménez Díaz

Description

Medicines used in clinical research must be distributed through the hospital pharmacology services. 

The service is charged with safekeeping and dispensing of medicines used for clinical research. 

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. 

The unit not only stores and dispenses drugs, but also does the following: 

  • 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; 
  • 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; 
  • re-labeling; 
  • management of expiration dates; and
  • destruction of samples. 

The Pharmacy is equipped with the following facilities for conservation of research samples: 

  • 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 alert to deviations in temperature. 

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