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薬理と治療
Abstract
Background Some problems may occur while collecting data during clinical trials. For example, case report forms(CRF)may not be submitted or data errors are present in the submitted CRF. These problems adversely affect the reliability of the results, cost of the trial, and the time required for publication. However, these problems should decrease by sufficient local data management. A few detailed studies have analyzed the process from data collection to solving problems. However, the situations in which problems tend to occur are unclear, and the local data management is insufficient. Methods We investigated problems that occurred in a past investigator-initiated clinical trial. Percentage of CRF deficiency, incidence rate of data errors, and the number of days required for participating physicians to answer queries during the trial were calculated. We focused on the involvement of a clinical research coordinator(CRC)and the number of patients registered per physician as factors influencing these problems;we explored the association between frequency of problems and these factors. Results Although the trend was not monotonic, physicians who did not submit CRFs, who had many data errors, and who took a long time to answer queries tended to be those who had not received the CRC support or those who had a small number of patients registered. Conclusion CRC support and the number of registered cases were associated with the response time required and the percentage loss of CRFs near the maximum value. Data errors tended to decrease if CRC support was provided or the number of registered cases was large.
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