Basics of case report form designing in clinical research.
Basics of case report form designing in clinical research.
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DOI：
10.4103/2229-3485.140555
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发表时间：
2014-10-01
影响因子：
--
通讯作者：
Latha, M S
中科院分区：
文献类型：
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作者：
Bellary, Shantala;Krishnankutty, Binny;Latha, M S
病例报告表（CRF）是临床研究中的专门文件。它应该是研究方案驱动的，内容稳健，并有材料收集研究特定数据。虽然纸质CRF仍被大量使用，但电子CRF（eCRF）的使用越来越受欢迎，因为它们具有提高数据质量、在线差异管理和更快的数据库锁定等优点。CRF开发的主要目标是保持和维护数据的质量和完整性。CRF设计应标准化，以满足所有用户的需求，如研究者、研究中心协调员、研究监查员、数据录入人员、医学编码员和统计员。数据的组织格式应便于和简化数据分析。大量数据的收集将导致在收集和处理数据时浪费资源，并且在许多情况下，将不会用于分析。除此之外，在设计通用报告格式时应遵循标准准则。应向研究中心工作人员提供CRF填写手册，以促进他们准确输入数据。这些措施将减少查询次数，提高数据完整性。建议建立和维持一个标准通用报告格式模块模板库，因为这样既节省时间又具有成本效益。本文介绍了临床研究中病例报告表的设计方法，并讨论了设计过程中遇到的问题。
Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.