The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):
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In accordance with medical research ethics, except for personal privacy information, trial data will be available for public inquiry and sharing, which will be limited to web-based electronic database
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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)数据采集:在有知情同意的情况下,由经统一培训的研究人员按照事先制定的研究者手册及SOP进行采集。在此期间,独立第三方监查员对数据的实时监查,以保证数据采集的准确性和完整性。为便于后期数据查对,所有数据修改应留痕。如为纸版CRF,更正记录或填写错误时不应改变原始数据,而应采用附加叙述,在原始错误之处划一条线并在旁边写上正确数据,同时写上修改理由,记录修改人员及修改时间。如在电子数据库录入数据时,则数据库系统应具有留痕功能,记录修改前的数据、修改理由、修改人员及日期等信息。
(2)数据录入:为避免数据录入过程中发生数据错误,要求由双人独立录入双份数据,如果两人录入不一致,应核对原始数据后再录入正确的数据。参与录入的人员,需进行必要录入培训,包括熟悉项目背景、CRF的结构与编码、数据库录入操作及录入的SOP。
(3)数据管理:在进行临床试验的过程中,把所有收集到的原始数据(如CRF和电子数据)存储在安全的地方,诸如受控的房间,保证相应的温度、湿度,具有完善的消防措施。
(4)数据核对:在数据录入完成后,需要进行数据核查与清理。对于存在缺失、逻辑矛盾、错误或不能确定的数据,以疑问表的形式由研究监查员传递给研究者,让研究者对疑问作出回答,经核实后再对数据库数据进行修订。数据核查与清理发现的任何问题,均应及时通知监查员,要求研究者作出回答。各种疑问及解答应应用疑问表,包括要求对数据的补充和复核等。所有疑问表和错误数据内容及修改结果应有详细记录并妥善保存。
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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) Data collection: With informed consent, uniformly trained researchers will collect data in accordance with the researchers' manual and SOP formulated in advance.During this period, independent third-party monitors monitor the data in real time to ensure the accuracy and completeness of data collection.In order to facilitate the later data check, all data modification should leave traces.In the case of paper CRF, the original data should not be changed when the record is corrected or the errors are filled in. Instead, additional statements should be used. A line should be drawn on the original error and the correct data should be written next to it.If inputting the date on the electronic database, the database system should have the function of leaving traces to record the data before modification, modification reason, modification personnel and date and other information.
(2) Data entry: In order to avoid data error in the process of data entry, two people are required to input two copies of data independently. If two people input inconsistent data, they should check the original data first, then enter the correct data.The staff involved in the input should receive necessary input training, including being familiar with the project background, CRF structure and coding, database input operation and SOP input.
(3) Data management: In the process of clinical trials, all the collected original data (such as CRF and electronic data) should be stored in a safe place, such as a controlled room, with corresponding temperature and humidity, and complete fire protection measures.
(4) Data verification: After the completion of data entry, data verification and cleaning are required.For the data with missing, logical contradiction, error or uncertainty, the researcher will be delivered to the researcher in the form of question list by the research supervisor, and the researcher will answer the question. After verification, the database data will be revised.Any problems found in data verification and cleaning should be notified to the supervisor in time and researchers should be required to answer them.All kinds of questions and answers should use the question sheet, including the request for data supplement and review, etc.All query tables and error data contents and modification results shall be recorded in detail and properly preserved.
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Publication information of the protocol/research results report (name of the journal, volume, issue, pages, time; or website):
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