关键词: font-size:medium, ">Ⅰ期临床试验；病历记录；书写规范；实践共识

Abstract: In order to standardize the writing of medical records of PhaseⅠ clinical trials， effectively ensure the traceability of data collected in clinical trials， strengthen the controlled management of source data， improve the research efficiency and quality of PhaseⅠ clinical trials， and protect the rights and safety of subjects/participants， China Forums of Clinical Research Capacity Building and Human Research Participants Protection（CCHRPP） set up a team of experts， according to the “Good Clinical Practice”， “Drug Registration Verification Points and Judgment Principles (Trial)” and other relevant provisions， referring to the “Basic Standards for Medical Record Writing”， “Medical Record Management Regulations for Medical Institutions (2013 edition)”， “Standards for Electronic Medical Record Application Management (Trial)” and other norms， jointly draft， review and formulate the “Practice Consensus on Requirement and Writing Standard for Medical Records of PhaseⅠ Clinical Trials” in accordance with practice. This consensus is applicable to PhaseⅠ clinical trials and clarifies： ①When electronic data acquisition system is available， the relevant examine data of the subjects/participants should be collected from the hospital information system (HIS)， laboratory information management system (LIS)， picture archiving and communication system (PACS) and other information systems of clinical trial institutions as the source data， covering the whole process data of trial screening period， enrollment， drug administration， sample collection and processing， safety observation and follow-up； ②When no electronic data acquisition system is available， the controlled paper medical record combined with the electronic medical record system should be used to record the test process. Paper records include informed consent， bound paper medical records， original record forms (drug management form， blood sample collection form， sample processing form， etc.)， which need to be controlled and managed， and the form is subject to version control. This consensus aims to provide practical reference for the writing of medical records of PhaseⅠ clinical trials. Studies of human bioavailability or bioequivalence can refer to this practice consensus.

Key words: font-size:medium, ">PhaseⅠ clinical trial； Medical record； Writing standards； Practice consensus