Assessment of the quality of sample labelling for clinical research

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. Method: 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. Outcome: 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.

Reliability assessment of a peer evaluation instrument in a team-based learning course

Objective: To evaluate the reliability of a peer evaluation instrument in a longitudinal team-based learning setting. Methods: Student pharmacists were instructed to evaluate the contributions of their peers. Evaluations were analyzed for the variance of the scores by identifying low, medium, and high scores. Agreement between performance ratings within each group of students was assessed via intra-class correlation coefficient (ICC). Results: We found little variation in the standard deviation (SD) based on the score means among the high, medium, and low scores within each group. The lack of variation in SD of results between groups suggests that the peer evaluation instrument produces precise results. The ICC showed strong concordance among raters. Conclusions: Findings suggest that our student peer evaluation instrument provides a reliable method for peer assessment in team-based learning settings.