The study of awareness of ukrainian clinical research professionals in gcp

Abstract

Aim. To assess whether Ukrainian clinical research professionals’ self-assessment of their GCP knowledge matches their actual (tested) GCP knowledge; to assess actual GCP knowledge in populations with different experience level, role in clinical trials, and number of attended GCP trainings; to assess whether short-term GCP trainings suffice for adequate professional level in GCP domain.
 Materials and methods. We developed a questionnaire which consisted of the following parts: demographic data, self-assessment of core competencies, tests on the basic issues of ICH GCP and assessment of the necessity for additional training. Data were analysed by using of description statistical methods and Kruskal-Wallis, Chi-square, Fisher exact test, and Mann-Whitney tests. Statistical analyses were performed using Statistica StatSoft software, Version 8.0 (StatSoft Power Solution Inc.).
 Results. We received 216 questionnaires with answers; some questionnaires were not fully completed and did not have answers to key questions of the study. Therefore, in the analysis, we included only 186 properly done questionnaires.
 Conclusions. Respondents' self-assessment of their competence level in GCP properly matches the test results. 
 Experience level did not substantially influence GCP knowledge. Regardless of experience level, the respondents demonstrated a low level of knowledge for the questions "randomization purpose according to ICH GCP" and "monitoring purposes according to ICH GCP". Both the group with high self-perceived competence and the group with low self-perceived competence demonstrated the level of knowledge above 70% for all other questions. 
 Respondents of the group, which brought together representatives of the regulatory authority, research ethics committees and contract research organizations had slightly better results than other clinical research professionals.
 The number of trainings attended did not affect the quality of knowledge demonstrated by respondents. Thus, an in-depth long-term academic training for clinical research professionals is warranted and is a possible topic for future research.
 Key words: clinical research competence domains; good clinical practice; clinical research professionals; professional development; self-assessment; clinical trials