ObjectiveThrough researching the "Automated Production Quality Management Specification 5th Edition" (GAMP5) promulgated by the International Society for Pharmaceutical Engineering, combined with domestic and foreign guidelines and regulatory requirements, to explore the practical methods for the verification of the central randomization system of clinical trials.MethodsThe GAMP5 verification process and specifications of the clinical trial central randomization system was established according to the GAMP5 guideline and domestic and foreign computerized system verification guidelines and regulations in combination with the characteristics of the clinical trial central randomization system, and the existing clinical trials central randomization system was used as an example to show the verification results.ResultsThe verification framework and process of the central randomization system met the requirements of the relevant regulations of clinical trials that had been constructed. For the existing system, a verification team was established, a verification plan was developed, and a computerized system verification was conducted in accordance with the V model to form a set of standardized verification documents.ConclusionsThe verification process of the central randomization system proposed by this research follows the GAMP5 specification and has high operability and reference value.
ObjectivesTo systematically review the necessary factors of questionnaires design on patients' values and preferences in order to provide information on the most appropriate questionnaires when developing clinical practice guidelines.MethodsA systematic literature search of PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data databases was performed to identify studies on questionnaires evaluating patient values and preferences. The authors included the articles that used fully structured questionnaires or scales with standardized questions and answer options. We assessed the questionnaires' construction with psychometric methodology and summarized the necessary factors on patients' preferences and values into the domains and items.ResultsTwenty articles were eventually included. Five out of 20 studies (25%, 5/20) described the process of item generation while merely one questionnaire (5%, 1/20) mentioned pilot testing. Regarding validity, there were 6 questionnaires (30%, 6/20) that assessed validity. For acceptability, the time taken to complete the questionnaires range from 10 to 30 minutes and only 6 studies reported response rates. The results showed that the factors affecting the design of questionnaires on patients' values and preference were related to the effectiveness, safety, prognostic factors and others. The main factors were the effects, side effects and risk of complications, risk of relapse and the cost of treatments.ConclusionsOnly a few studies have developed questionnaires with rigorous psychometric methods to measure patients' preference and values. There is still no valid or reliable questionnaires for patients' preference and values when developing clinical practice guidelines. Further study should be conducted to develop standardized instruments to measure patients' preference and values. It is suggested that the factors this study provides can be used in formulating questionnaires on patients' preference and values.