数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:
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研究者根据受试者的原始观察记录,将数据及时、完整、正确、清晰地载入病例报告表。
监查员监查试验的进行是否遵循试验方案。确认所有病例报告表填写正确完整,并与原始资料一致。如有错误和遗漏,及时要求研究者改正。修改时需保持原有记录清晰可见,改正处需经研究者签名并注明日期。
经过监查员检查后的病例报告表,由监查员核查签字后,及时送交临床试验数据管理员。对于完成的病例报告表在研究者、监查员、数据管理员之间的传送应有专门的记录,收到时应有相应的签名,记录需妥善保存。
数据管理员在数据录入前再次核查,发现问题及时通知监查员,要求研究者作出回答。他们之间的各种疑问及解答的交换应当采用疑问表形式,疑问表应保存备查。
数据管理员在进行数据录入前,要了解观察表格各项目的内容及编码情况,将编码工作过程记录于编码本保存。数据库命名应规范、易读、易查找。并保证其正确、安全和保密。
数据录入员录入数据采用二次录入。录入过程发现问题或意外情况,应做好登记并及时报告,以便迅速处理问题,数据录入结束后应抽查部分观察表格,了解录入质量,分析并处理存在的问题。
数据管理员应与主要研究者一起,按病例报告表中各指标数值的范围和相互关系拟定数据范围检查和逻辑检查内容。并编写相应的计算机程序,在输入前控制错误数据输入,找出错误原因加以改正,所有错误内容及修改结果应有记录并妥善保存。
原始病例报告表在按要求完成数据录入和核查后,按编号的顺序归档保存,并填有检索目录等,以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,应分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏。所有原始档案应按我国《药品临床试验管理规范》的规定期限保存。
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:
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According to the original observation records of the subjects, the researchers loaded the data into the case report form in a timely, complete, correct and clear manner.
The supervisor inspects whether the test follows the test plan. Confirm that all case report forms are filled in correctly and completely, and are consistent with the original data. If there are errors and omissions, ask the researchers to correct them in time. The original records shall be kept clearly visible during modification, and the corrections shall be signed and dated by the researchers.
The case report form checked and signed by the supervisor shall be sent to the clinical trial data administrator in time. There should be special records for the transmission of the completed case report form between researchers, supervisors and data administrators, and the corresponding signatures should be provided when receiving it, and the records should be properly kept.
The data administrator checks again before data entry, and notifies the supervisor in time if any problem is found, asking the researcher to answer. The exchange of various questions and answers between them should be in the form of a question list, which should be kept for future reference.
Before data entry, the data administrator should understand the contents and coding of each item in the observation form, and record the coding process in the coding book for storage. The database naming should be standardized, easy to read and easy to find. And ensure its correctness, security and confidentiality.
The data entry clerk adopts secondary entry to enter data. If problems or accidents are found during the entry process, they should be registered and reported in time, so as to deal with the problems quickly. After the data entry, some observation forms should be spot checked to understand the entry quality, analyze and deal with the existing problems.
The data administrator should work with the main researchers to formulate the data range check and logic check content according to the range and correlation of each index value in the case report form. And prepare corresponding computer programs, control the input of wrong data before input, find out the cause of the error and correct it. All error contents and modification results should be recorded and properly saved.
After completing data entry and verification as required, the original case report form shall be filed and saved in numbered order, and filled with a search directory for future reference. Electronic data files, including databases, inspection procedures, analysis procedures, analysis results, codebooks and description documents, should be stored by classification, and multiple backups should be stored on different disks or recording media, which should be properly stored to prevent damage. All original files shall be kept for the period specified in China's code for the administration of clinical trials of drugs.
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