title: Assessment of the quality of sample labelling for clinical research.
abstract: OBJECTIVE
  To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample.
  
  
  METHODS
  A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed.
  
  
  RESULTS
  The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis.
  
  
  CONCLUSIONS
  The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors.
authors.affiliation: Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.. pablopehu@gmail.com.
authors.forename: Pablo
authors.initials: P
authors.lastname: Pérez-Huertas
authors.affiliation: Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.. tordera_mar@gva.es.
authors.forename: María
authors.initials: M
authors.lastname: Tordera-Baviera
authors.affiliation: Pharmacy Service, Hospital Universitario de la Princesa, Madrid.. cmartinezn.hlpr@salud.madrid.org.
authors.forename: Concepción
authors.initials: C
authors.lastname: Martínez-Nieto
authors.affiliation: Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.. benito_nat@gva.es.
authors.forename: Natalia
authors.initials: N
authors.lastname: Benito-Zazo
authors.affiliation: Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.. garcia_anarob@gva.es.
authors.forename: Ana
authors.initials: A
authors.lastname: García-Robles
authors.affiliation: Pharmacy Service, Hospital Universitario y Politécnico La Fe, Valencia.. poveda_josand@gva.es.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Poveda-Andrés
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control / Q000706:statistics & numerical data