The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):
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Share through academic 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 建立数据库
由承担本研究的数据助理及管理人员,负责建立数据库及全部数据的录入工作,采用excel表格进行数据管理工作。
2 数据录入与双份核查
数据录入与管理由数据管理员负责。为保证数据的准确性,应由两个数据管理员独立进行双份录入并校对。再随机抽取若干份病例报告表和数据库中的数据进行人工比较,以确保数据库中的数据与原始CRF表中的结果一致。
数据录入同时发出疑问,如日期、入组标准、排除标准、脱落、缺失值等,特别对统计分析的重要指标利用计算机程序进行详细检查,由研究者对疑问表中的问题进行书面解答并签名后,再统一由研究助理录入系统。对于系统疑问,研究者应尽快予以解答,答疑后数据必要时可再次发出疑问。
3 数据审核与数据库锁定
系统中所有数据疑问解决后,“清洁”数据导出,交统计人员,由主要研究者、统计分析人员对数据进行数据审核,同时定稿统计计划书。数据盲态核查报告和统计计划书定稿后,锁定数据,并按统计分析计划进行统计分析。
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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 Create a database
The data assistant and management personnel responsible for this study are responsible for the establishment of the database and the entry of all data, and the data management work is carried out by using excel tables.
2 Data entry and double verification
Data entry and management is the responsibility of the data manager. In order to ensure the accuracy of the data, two data managers should independently make two copies of the input and proofread. A number of case report forms were randomly selected and manually compared with the data in the database to ensure that the data in the database was consistent with the results in the original CRF table.
At the same time, questions are issued for data entry, such as date, inclusion criteria, exclusion criteria, drop off, missing value, etc. In particular, important indicators of statistical analysis are examined in detail by computer programs. After written answers and signatures of questions in the question table are given by researchers, they are uniformly entered into the system by research assistants. For questions about the system, the researcher should answer them as soon as possible, and after answering the questions, the data can be asked again if necessary.
3 Data audit and database locking
After solving all the data questions in the system, the "clean" data is exported and handed over to the statisticians, and the data is reviewed by the main researchers and statistical analysts, and the statistical plan is finalized. After the data blind verification report and statistical plan are finalized, the data is locked and analyzed according to the statistical analysis plan.
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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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