CRF tables on the clinical trials databasestatistical batch holographic marriage Preliminary Model.docVIP

 PAGE \* MERGEFORMAT 20 CRF tables on the clinical trials databasestatistical batch holographic marriage Preliminary Model Of: Wang Shiliang Xujian Jian Yang, Cheng-Ye Hong top [Abstract] Objective: To investigate the clinical trials database statistics batch CRF table holographic “marriage” model. Methods: According to the table to create an electronic CRF CRF hard copy form, and load the library operating procedures, and nearly 10 commonly used statistical module, and thus constitutes a holographic database . Results: In Shanghai, a large clinical trial data as a test run of the material in this database, data elements handled about 11 million, to make statistical judgments about 1,000 copies, call statistics tool 8, the conversion of data types in more than 10, running time is only half an hour, comprehensive report issued by large-scale test 2 copies of the report, more than 20 copies of statistical induction. Conclusion: This electronic data acquisition system can be used as the application of the transition EDC, EDC is also comprehensively promote the early stage of practice. [Keywords: clinical trial; CRF tables; database Clinical trials of new drugs, frequent use of tens to hundreds of clinical case reports, case report form (CRF), currently more than the paper version of form to record details of study patients before and after clinical trials in a variety of physical, signs of parameters , clinical management process and test results. This has a few hundred copies, each with a dozen clinical observation of the table on page constitutes a large data bank of information, processing and statistics which is a very comprehensive system engineering . and these statistics and the formation process of data results, and the regulatory requirements have a strong, direct relationship with the goal of clinical trials, such as the success of a new drug approval. according to the provisions of GCP: “The purpose of the Data Management The data obtained f