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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1、填写CRF
研究者根据受试者的住院病历、原始观察记录,及时、完整、正确、清晰地填写病例报告表。
2、核对CRF
监查员监督试验是否遵循试验方案。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,及时要求研究者更正。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。
3、收回CRF
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。
4、发疑问表
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。
5、建立数据库
在北京中医药大学东直门医院药物临床试验机构,采用EpiData3.1数据管理软件,建立数据库。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。
6、数据录入
数据录入员录入数据采用独立双次录入。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。
7、数据库核查
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。
8、数据备份
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。所有原始档案按我国《药物临床试验质量管理规范》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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1. Fill in the CRF
The investigator filled in the case report form in a timely, complete, correct and clear manner according to the subjects' hospitalization records and original observation records.
2. Check CRF
Monitors monitor whether the trial follows the trial protocol. 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, the researchers should be promptly requested to correct them. The original records should be kept clear and visible during revisions, and the corrections should be signed and dated by the researcher.
3. Recover CRF
The case report form after inspection by the inspector shall be checked and signed by the inspector, and then sent to the clinical trial data administrator in a timely manner. There should be special records for the transmission of completed case report forms between investigators, supervisors, and data administrators, and corresponding signatures should be given upon receipt, and the records should be properly kept.
4. Question form
The data administrator checks again before data entry, and if any problem is found, the inspector is notified in time, and the researcher is required to answer. The exchange of various questions and answers between them shall be in the form of a question form, which shall be kept for future reference.
5. Create a database
In the drug clinical trial institution of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine, EpiData3.1 data management software was used to establish a database. Before data entry, the data administrator should understand the content and coding of each item in the observation form, and record the coding process in the codebook for preservation. Database naming should be standardized, easy to read, and easy to find. and keep it correct, secure and confidential.
6. Data entry
Data entry by the data entry staff adopts independent double entry. If problems or unexpected situations are found in the input process, they should be registered and reported in a timely manner, so that the problems can be handled quickly. After the data input is completed, some observation forms should be checked to understand the input quality, and analyze and deal with the existing problems.
7. Database verification
The data administrator should work with the principal investigator to formulate the content of data range checks and logical checks according to the ranges and interrelationships of each indicator value in the case report form. And write the corresponding computer program, control the input of wrong data before input, find out the cause of the error and correct it, all the wrong content and modification results should be recorded and properly stored.
8. Data backup
After completing the data entry and verification as required, the original case report form shall be archived and stored in the order of numbers, and filled with retrieval catalogues for future reference. Electronic data files, including databases, inspection programs, analysis programs, analysis results, codebooks, and description files, etc., should be stored in categories, and multiple backups should be stored on different disks or recording media to be properly stored to prevent damage. All original files are kept for the period specified in my country's "Good Clinical Practice for Drug Clinical Trials".
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