The validation of a questionnaire to delineate clinical research coordinator roles in China

The purpose of this study was to evaluate the roles of the clinical research coordinator (CRC) in clinical oncology trials.

An E-questionnaire that includes 10 sections with 155 items total and is based on the Clinical Trials Nursing Questionnaire (CTNQ) was designed to determine the conditions of demographics, competences, activities, and psychology for Chinese CRCs. Eighty-two CRCs from three different provinces in China were invited to join this study anonymously. Cronbach's α and split-half reliability were calculated to assess the reliability and validity of the questionnaire. Additionally, the Wilcoxon rank-sum test was used to find the similarity and difference between the importance of the roles of CRCs and their frequency. The STROBE checklist for observational research has been following for presenting the research (see File S1).

Cronbach's α values of the Chinese version of the questionnaire for the frequency scale and the importance scale were .965 and .961, respectively. The split-half reliability coefficients were 0.866 and 0.805, respectively. Pearson correlation coefficients of the subscales indicated that the correlation between each item and its dimension was greater than its correlation with the other components (P < .05). Exploratory factor analysis results show that three common factors were extracted by principal component analysis and had eigenvalues greater than 1 and that the cumulative contribution rate was 69.415%.

The Chinese version of the questionnaire has good reliability and validity for CRCs in China, which could be promoted in evaluating clinical research coordinator roles in China.