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、临床试验筛选时,应保留相关筛选记录,包括受试者的人口学资料、一般体格检查、病史、病程及治疗、伴随疾病及伴随治疗、实验室检查化验单、重要的疾病诊断依据等,核实受试者筛选的入选/排除标准,并记录在eCRF中在临床试验实施过程中,受试者接受的所有治疗均应如实详细记录在eCRF中,并客观评估其对有效性和安全性的影响。
eCRF填写
对于每一位进入本研究的受试者,数据录入由临床研究者或由研究者授权的研究助理完成。
eCRF中的数据应与原始记录一致,试验中的任何观察、检查结果均应及时、准确、完整、规范、真实地填写于eCRF中,不得随意更改。eCRF中所有项目均需填写,不得空项或遗漏。如有需要,eCRF进行数据更正时,需按照系统提示,填写数据修改的原因。 eCRF审核
研究者在每位受试者当前访视结束后,在规定时间内完成eCRF的填写,审核并提交。研究者应及时回复来自监查员、数据管理员、医学审核人员的质疑。在数据清理完成后,研究者对填写完毕的eCRF签名确认。
数据核查
研究者填写并提交eCRF后,监查员、数据管理员以及医学审核人员应对数据进行审核,审核发现的问题,以质疑的形式要求研究者回答。数据清理完毕后,eCRF需研究者电子签名确认
2、本研究采用电子数据采集(EDC)系统,通过EDC系统的电子数据录入、数据的验证、数据的核查等功能,完成在线数据管理。EDC系统管理员根据研究者、监查员、稽查员、数据管理员等不同角色,分别创建不同账号,依据用户使用人的不同角色设定相应的权限。
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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. During clinical trial screening, relevant screening records should be kept, including demographic data, general physical examination, medical history, course and treatment of the subject, concomitant diseases and concomitant treatment, laboratory test reports, important disease diagnosis basis, etc. , To verify the selection/exclusion criteria of the subject screening and record it in the eCRF. During the implementation of the clinical trial, all the treatments received by the subject should be truthfully recorded in the eCRF and objectively evaluated for effectiveness and safety Impact.
eCRF fill
For each subject who enters this study, data entry is completed by the clinical investigator or a research assistant authorized by the investigator.
The data in the eCRF should be consistent with the original record, and any observations and inspection results in the test should be filled in the eCRF in a timely, accurate, complete, standardized and true manner, and should not be changed at will. All items in the eCRF must be filled in, and no blanks or omissions are allowed. If necessary, when eCRF performs data correction, you need to follow the system prompts and fill in the reason for the data modification. eCRF review
After the current visit of each subject is over, the researcher will complete the eCRF fill-in, review and submit within the specified time. Researchers should promptly respond to queries from monitors, data administrators, and medical reviewers. After the data cleaning is completed, the researcher confirms the completed eCRF signature.
Data check
After the researcher fills in and submits the eCRF, the monitors, data administrators, and medical reviewers should review the data, and ask the researcher to answer the questions found in the review in the form of queries. After the data is cleaned, eCRF requires the researcher’s electronic signature to confirm
2. This research uses an electronic data collection (EDC) system to complete online data management through the electronic data entry, data verification, and data verification functions of the EDC system. The EDC system administrator creates different accounts according to the different roles of researchers, inspectors, auditors, data administrators, etc., and sets corresponding permissions according to the different roles of users.
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