医疗器械临床试验中人数如何确定（How is the number of medical device clinical trials determined）.doc

医疗器械临床试验中人数如何确定（How is the number of medical device clinical trials determined） The clinical trials in statistical problems clinical trials of medical devices regulations fourteenth requirements, the clinical trials protocol should be based on the specific characteristics of the product to be tested in clinical trials to determine the number of cases, the duration and clinical evaluation standard, the result was statistically significant. Therefore, the statistical problems of medical devices in clinical trials is essential, mainly reflected in the following aspects: (a) the test data management in order to ensure the quality of clinical trials, the applicant shall appoint the arbitrator to monitor experience the whole process of clinical trials. The arbitrator plays the role of a bridge between researchers and data administrators. In order to ensure the traceability of data, should do the following work: 1, for each clinical trial of all subjects, should establish the original observation records (such as records) and case report in triplicate, carbonless copy table (CRF). 2. After each follow-up visit, the investigator should fill in the case report in a timely, accurate, complete and unmistakable manner. After the end of the trial, the case report form shall be sent to the original monitor data administrator, the remaining two copies respectively by the researchers and the sponsor to hold one respectively, in order to find the error of CRF time and effectively corrected and modified in the test monitoring and data management. 3, the data administrator should establish the database according to the case report form, and ensure the correctness of the database operation. Clinical trials for a long time, follow-up research many times, in order to find the implementation of clinical trials and CRF fill problems in data management and statistical analysis, shorten the time, can take every follow-up to send a CRF to the data management and statistical analysis of agency