icf-review临床试验知情同意书(ICF)全面审查 — 基于GCP/ICH-GCP/FDA/中国法规，对知情同意书进行合规性、完整性、伦理合理性审查，输出结构化审查报告。触发词：审查知情同意书、ICF审查、IRB审查、知情同意审查。
Install via ClawdBot CLI:
clawdbot install kenlcj/icf-reviewGrade Fair — based on market validation, documentation quality, package completeness, maintenance status, and authenticity signals.
Sends data to undocumented external endpoint (potential exfiltration)
Report → https://www.hhs.gov/ohrp/regulations-and-Calls external URL not in known-safe list
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinicaAI Analysis
The external URLs referenced (hhs.gov, fda.gov) are official U.S. government regulatory websites. Accessing these for guidance is consistent with the skill's stated purpose of regulatory compliance review and does not constitute unauthorized data exfiltration or credential harvesting. No hidden instructions or obfuscation were found in the provided definition.
Audited Apr 18, 2026 · audit v1.0
Generated May 19, 2026
医院IRB秘书或委员使用此技能快速审查研究人员提交的知情同意书，确保符合GCP和伦理要求。审查结果可生成结构化报告供会议讨论或归档，提高审查效率和一致性。
合同研究组织（CRO）或临床现场管理组织（SMO）利用该技能为申办方进行ICF全面审查，输出专业报告，作为增值服务。可批量处理多中心ICF，确保各中心版本统一合规。
药企QA部门在临床试验启动前，使用该技能对ICF进行独立审核，识别风险点并督促修正。降低因知情同意问题导致的监管风险或受试者投诉。
研究者自发开展非注册临床研究时，可使用该技能自查ICF是否涵盖所有强制条款，避免伦理审查被驳回。特别适用于缺乏专业CRO支持的小型研究团队。
医学院或临床研究培训中心将本技能作为教学案例，用于培养医学生和研究者对知情同意书结构、法规和伦理要点的理解。学员可通过模拟审查练习提升合规意识。
针对小型药企或研究者发起的试验，提供单份ICF审查并输出报告，每份收取固定费用（如2000-5000元）。适合需求偶发、不愿签署年度合同的客户。
将技能打包为API或插件，嵌入临床试验管理系统（CTMS）或电子知情同意平台，按年订阅收费。客户可在系统内直接调用审查功能，实现流程自动化。
以该技能为核心开发线上课程，教授ICF审查方法，包含案例实操。学员完成考核可获证书，课程定价199-499元/人。可向医院、CRO、药企批量销售。
💬 Integration Tip
可集成到临床试验管理系统（CTMS）或电子知情同意（eIC）平台中，实现ICF上传后自动审查并反馈报告。建议提供批量审查API，支持同时处理多中心ICF版本对比。
Scored May 19, 2026
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