坚守临床数据生命线｜麦科奥特标准化 HIS 溯源质控体系，筑牢多肽新药研发合规根基
MICOT
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麦科奥特深耕双功能多肽新药研发，布局全国多中心临床试验，始终将数据真实、全程可溯源作为核心质控准则。HIS、LIS、EMR、PACS 院内系统溯源核查，是临床试验合规管控的核心抓手。
一、四大院内核心溯源系统
院内四大信息系统属于一级原始源数据，所有试验纸质记录必须与系统数据匹配、全程留痕：
HIS：就诊、药房、收费、受试者身份信息，核验入组真实性；
LIS：生化、免疫等检验原始报告；
PACS/RIS：CT、X 光、心电图影像存档；
EMR：诊疗记录、不良事件 AE、合并用药 CM。
二、常态化 HIS 溯源的核心意义
溯源管理缺位极易引发稽查重大缺陷，阻滞新药申报进程，因此公司将系统溯源设置为项目强制质控项：
核验受试者就诊真实性，防范身份信息造假；
留存不可篡改系统操作日志，构建完整稽查证据链；
抓取门诊用药、检验异常信息，完整评估药物风险获益；
前置化解合规隐患，规避数据冲突、资料无法溯源等严重问题。
三、标准化 HIS 核查三大准则
依托公司标准化质控管理体系，全国所有多中心执行统一核查规范，严格落实 “广、细、勤” 三大溯源核查准则：
查得广：全覆盖各业务系统，提前核实新旧系统数据留存情况；
查得细：多维度交叉校验受试者信息，完整归档病历修改痕迹；
查得勤：每次监查同步完成溯源核对，第一时间修正数据偏差。
四、申办方落地管控措施
前期调研机构系统条件：中心筛选、启动阶段梳理系统权限、纸质影像存档等问题，配套专项备份方案；
统一病历管理规范：电子病历修改同步更新纸质版本，新旧资料全部归档留痕；
双通道核查安全数据：联动 HIS 药房、检验记录，补齐 AE/CM 相关记录；
标准化溯源档案闭环：统一归档系统截图、源数据鉴认表，随时应对药监稽查。
高频疑问速答
HIS 系统记录是否为原始资料？
是，院内后台原始数据采信优先级高于纸质打印单据。
核查 HIS 是否需使用研究者账号？
优先开通监查专用只读账号；无专属权限时，在研究者陪同下查阅并留存记录。
电子与纸质记录不一致如何处置？
调取系统修改日志，同步更新纸质资料；撰写《数据澄清说明》，清晰列明差异内容、真实原始数据、差异成因及整改措施，经研究者签字后，与病历一并作为源文件附件归档留存，同步报送质量管理部门备案。
麦科奥特标准化 HIS 溯源质控体系核心优势
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多中心标准统一：一套核查流程、归档模板覆盖全部合作中心，抹平各医疗机构系统差异；
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风险前置管控：从项目早期排查系统隐患，常态化监查及时纠偏，避免申报阶段集中爆发缺陷；
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多维度数据保真：联动四大院内系统交叉核验，完整捕捉门诊安全信息，杜绝数据不实、记录遗漏；
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多方协同高效：统一操作指引与问题处置流程，降低 PI、机构、监查团队落地执行负担。
严苛临床质控是麦科奥特多肽创新药研发的坚实底座，标准化 HIS 溯源体系是全链条质量管控的关键一环。未来公司将持续联动全国各临床机构，共建合规透明的临床试验生态，依托高质量临床数据加速创新多肽药物落地，满足临床未被满足的治疗需求。
MICOT
Micot focuses on the R&D of dual-functional polypeptide new drugs and carries out multi-center clinical trials nationwide. It always takes authentic data and full traceability as the core quality control principle. Traceability verification of hospital systems including HIS, LIS, EMR and PACS serves as the core measure for compliance control of clinical trials.
Four Core Hospital Traceability Systems
The four hospital information systems are primary source data, and all paper trial records shall be consistent with system data with full audit trails.
Hospital Information System (HIS): consultation, pharmacy, charging and subject identity information to verify the authenticity of enrollment
Laboratory Information System (LIS): original test reports of biochemistry, immunology and other items
Picture Archiving and Communication System / Radiology Information System (PACS/RIS): archives of CT, X-ray and ECG images
Electronic Medical Record (EMR): medical records, Adverse Events (AE) and Concomitant Medications (CM)
Core Significance of Regular HIS Traceability
Insufficient traceability management may lead to critical inspection findings and delay new drug application. Therefore, systematic traceability is designated as a mandatory quality control item for all projects:
Verify the authenticity of subjects’ medical visits and prevent identity fraud
Preserve tamper-proof system operation logs to form a complete audit evidence chain
Capture outpatient medication and abnormal test data to comprehensively assess the risk-benefit profile of investigational products
Eliminate compliance risks in advance and avoid severe issues such as inconsistent data and untraceable documents
Three Standardized Principles for HIS Verification
Based on the company’s standardized quality control system, all national multi-centers follow unified verification standards and strictly implement the three traceability principles: Comprehensive, Detailed, Timely.
Comprehensive: Cover all business systems and confirm data retention of old and new systems in advance
Detailed: Cross-check subject information from multiple dimensions and fully archive medical record revision trails
Timely: Conduct traceability verification alongside each monitoring visit and correct data deviations promptly
Sponsor’s Implementation & Control Measures
Pre-assess institutional system conditions: Sort out issues including system access authority and paper image archives during site selection and initiation, and formulate dedicated backup plans
Unify medical record management specifications: Update paper versions synchronously after EMR revisions, and archive all old and new documents with trails
Dual-channel safety data verification: Cross-reference HIS pharmacy and laboratory records to complete missing AE/CM documentation
Closed-loop standardized traceability filing: Uniformly archive system screenshots and source data authentication forms to prepare for regulatory inspections
Frequently Asked Questions
Are HIS system records regarded as
source data?
Yes. Back-end hospital system data takes precedence over printed paper documents during inspections.
Is the investigator’s account required
for HIS verification?
A dedicated read-only monitoring account shall be applied first. If unavailable, access the system accompanied by the investigator and keep relevant records.
How to handle inconsistencies between
EMR and paper records?
Retrieve system revision logs and update paper documents synchronously. Compile a Data Clarification Statement that clearly records inconsistent contents, authentic source data, root cause analysis and corrective actions. The document shall be signed by the investigator, filed as an attachment to source documents for inspection, and submitted to the Quality Management department for filing.
Core Advantages of MICOT Standardized HIS Traceability QC System
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Unified multi-center standards: One set of verification workflows and filing templates for all partner sites to eliminate gaps caused by different hospital systems
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Proactive risk control: Identify system hidden risks at early project stages and rectify problems via regular monitoring to avoid concentrated findings before application
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Multi-dimensional data authenticity guarantee: Cross-verify data via four hospital systems, fully capture outpatient safety information and prevent false data & missing records
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Efficient multi-party collaboration: Unified operation guidelines and issue handling procedures reduce implementation burden for PIs, institutions and monitoring teams
Rigorous clinical quality control serves as the solid foundation of Micot’s polypeptide new drug R&D, and the standardized HIS traceability system is a key link in full-chain quality management. Moving forward, the company will continuously cooperate with clinical institutions nationwide to build a compliant and transparent clinical trial ecosystem. Relying on high-quality clinical data, we will accelerate the launch of innovative polypeptide drugs to address unmet clinical medical needs.
MICOT
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