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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
（1）基本要求
1）及时 数据能及时地被记录于医疗档案是首要要求。及时记录的数据能反映受试者即时的病情，可避免补记时由于回忆不准确所造成的误差。
2）完整 完整收集研究数据，就是要求收集所有研究对象的全部资料。一方面，是要按临床观察表格的要求填写全部数据，另一方面是收集全部研究对象的资料）准确 设计的观察表格应有较好的可操作性，应尽量采用计量化的指标，对软指标也尽可能地做适当的量化。通过实验室的质量控制等措施，保持实验室条件（诸如仪器、检测环境、检测方法和操作人员）的相对恒定。临床医师或资料收集者在收集资料或填写观察表时需经过一定的培训，或者至少需要在填写前熟悉填写要求和注意事项，并通过检查来确认所有的资料收集者都能较为一致地掌握资料的收集方法。
（2）保障措施
1）责任与态度 各类人员应分工明确，以科学求实的态度记录客观情况和反映主观感觉。资料收集者认真填写观察表格，字迹应清楚易辨认。
2）加强培训 培训的目的是提高资料收集者的内部观察一致性和观察者间一致性，以保证临床研究结论的可靠性，并以此为指标来评价培训的效果。
3）防止错漏 资料收集者在收集资料前接受培训，在记录前认真了解填表说明，完成记录或填写之后，进行自我复查，可以很大程度上减少错漏的机会。
4）改错方式 更正记录或填写的错误时，为便于查对应将错误之处划线而不是涂黑，然后在旁边写上正确的内容、理由、改正日期，并有修改人签字。
5）监督与检查 对资料收集者的工作应进行监督和检查，核对资料收集数量和质量，定期或不定期地抽查已完成的观察表及正在填写的观察表，发现问题应及时反馈给收集者避免同类错漏情况的再次出现。
（3）原始资料记录要求
1）基本要求：真实、及时、准确、完整，防止漏记和随意涂改。不得伪造、编造数据。
2）按照试验方案，逐项详细记录，不能留空项。所有文字数据资料一律用钢笔或签字笔书写，不得用铅笔、圆珠笔，字迹应清楚端正。如需修改，只能划线并保持原记录可辨认，不能涂盖，旁注改后的数据，签名并注明日期，如有必要，应注明修改理由。
3）对于自觉症状的描述应当客观，切勿诱导或暗示，对于所规定的客观指标，应当按方案规定的时点、间隔和方法进行观察或检测，并按检测日期先后粘贴检验原始报告单。
4）对临床可接受范围以外的数据须加以核实。
5）剔除的病例也应保留原始记录。
2.数据管理职责
（1）研究者、主要研究者对原始资料数据的真实、完整、准确负责，监查员负责对此进行审核。
（2）各试验中心机构办公室和档案室负责对本机构完成的试验病例的资料归档。
（3）数据录入员与数据分析员对CRF和数据库录入的正确性负责。
（4）研究者应确保任何观察与发现均正确而完整地记录于病例报告表上，记录者应在表上签名。
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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
(1) Basic requirements
1) Timeliness It is a primary requirement that data be recorded in the medical record in a timely manner. Timely recording of data reflects the subject's immediate condition and avoids errors caused by inaccurate recall during retrospective recording.
2) Completeness The complete collection of study data means that all information on all subjects is required. (On the one hand, it is necessary to fill in all the data as required by the clinical observation form, and on the other hand, it is necessary to collect information on all study subjects.) Accurate The observation form designed should be well operable and should use as many measurable indicators as possible, and soft indicators should be appropriately quantified as far as possible. The relative constancy of laboratory conditions (e.g. instruments, test environment, test methods and operators) is maintained through measures such as quality control in the laboratory. Clinicians or data collectors need to have some training in collecting data or completing observation forms, or at least need to be familiar with the requirements and precautions before completing them, and to check that all data collectors have a more consistent grasp of the data collection methods.
(2) Safeguards
1) Responsibilities and attitudes All categories of personnel should have a clear division of labour to record objective situations and reflect subjective feelings in a scientifically realistic manner. Data collectors should fill in the observation forms carefully, and the handwriting should be clear and legible.
The aim of training is to improve the internal consistency of observations and inter-observer consistency among data collectors in order to ensure the reliability of clinical research findings, and to use this as an indicator to evaluate the effectiveness of training.
3) Prevention of errors and omissions Data collectors can largely reduce the chances of errors and omissions by receiving training before collecting data, carefully understanding the instructions for completing the form before recording, and conducting a self-check after completing the record or filling it out.
4) Correction of errors When correcting errors in records or completions, the error is underlined rather than blacked out for ease of reference, and then the correct content, reason, date of correction and the signature of the person making the correction are written next to it.
(5) Supervision and inspection The work of the data collector should be supervised and inspected, the quantity and quality of data collected should be checked, and completed observation forms and those being completed should be randomly checked on a regular or irregular basis, and any problems found should be fed back to the collector in time to avoid the recurrence of similar errors and omissions.
(3) Requirements for recording original information
(1) Basic requirements: truthful, timely, accurate and complete, prevent omissions and random alterations. No falsification or fabrication of data.
(2) In accordance with the test programme, record in detail item by item and do not leave blank items. All written data should be written in pen or signature pen, not in pencil or ballpoint pen, and the handwriting should be clear and correct. If corrections are required, only underline and keep the original record legible, do not cover it, annotate the corrected data, sign and date it and, if necessary, state the reason for the change.
(3) Descriptions of self-conscious symptoms should be objective and never induced or implied. For the objective indicators specified, observations or tests should be made at the points, intervals and methods specified in the protocol, and the original test reports should be affixed in order of the date of testing.
4) Data outside the clinically acceptable range shall be verified.
(5) The original records should also be kept for rejected cases.
2. Data management responsibilities
(1) The investigator and principal investigator are responsible for the authenticity, completeness and accuracy of the original data, and the supervisor is responsible for auditing this.
(2) The institutional office and archives of each trial centre are responsible for archiving the data of the trial cases completed at their institution.
(3) Data entry clerks and data analysts are responsible for the correctness of CRF and database entries.
(4) The investigator should ensure that any observations and findings are correctly and completely recorded on the case report form, which should be signed by the recorder.
*** Translated with www.DeepL.com/Translator (free version) ***
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