{"version":"training-draft-2026-10-30","scope":"仅供培训和界面演示；不含受试者、ePRO、IRT、实验室或治疗分配的真实数据，不提供医疗或剂量建议。最终规则以获批 Protocol、ICF、DMP、中心实验室手册与当地要求为准。","sources":[{"label":"ICH E6(R3) Good Clinical Practice","url":"https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf"},{"label":"FDA Population Pharmacokinetics Guidance","url":"https://www.fda.gov/media/71364/download"},{"label":"FDA Electronic Source Data Guidance","url":"https://www.fda.gov/media/85183/download"},{"label":"季节性过敏性鼻炎患者 eDiary 依从性观察研究","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7105930/"}],"signals":[{"id":"pk-schedule-observe","mode":"PK 访视","code":"PK-SCH-01","title":"预约尚未确认","severity":"观察","trigger":"访视前 72 小时仍未确认","owner":"CRC","action":"标记观察信号并按受控渠道提供中性预约支持。"},{"id":"pk-schedule","mode":"PK 访视","code":"PK-SCH-02","title":"预约仍未确认","severity":"一般","trigger":"访视前 24 小时仍未确认","owner":"CRC","action":"在 1 个工作日内按已同意的中性渠道联系；不变更用药。"},{"id":"pk-window-prepare","mode":"PK 访视","code":"PK-WIN-01","title":"给药—采血准备风险","severity":"一般","trigger":"准备提示点前未确认到达、给药记录或采血资源","owner":"CRC","action":"核对实际资源和时钟；保留事实，不向受试者追加技术性给药指令。"},{"id":"pk-window","mode":"PK 访视","code":"PK-WIN-02","title":"给药—采血可能超窗","severity":"重大","trigger":"实际到达或给药时间意味着可能超出最终方案窗口","owner":"CRC / PI","action":"记录计划与实际时间、偏差分钟数和原因；不得倒填、补服或擅自加采。"},{"id":"pk-dose","mode":"PK 访视","code":"PK-DOS-01","title":"实际给药时间不可核实","severity":"重大","trigger":"eDiary、直接观察、药物责任或受试者报告无法提供可靠时间","owner":"CRC / PI","action":"保留不确定状态并按预设规则处理；不得用计划时间替代实际时间。"},{"id":"pk-limit","mode":"PK 访视","code":"PK-LIMIT-01","title":"额外 PK 采血上限","severity":"重大","trigger":"拟创建第 5 次额外 PK 采血","owner":"CRC / PI","action":"系统硬阻断登记；不以失败或错过的样本为由自行增加替代采血。"},{"id":"pk-coc","mode":"PK 访视","code":"PK-COC-01","title":"样本链路信息异常","severity":"重大","trigger":"标签、采集、处理、冷冻、温度、运输或收样状态缺失/异常","owner":"CRC / 中心实验室","action":"保留样本和原始记录，创建质量标记并依实验室/数据管理规则判定。"},{"id":"ediary-two","mode":"eDiary","code":"EDI-MISS-02","title":"连续 2 日未完整记录","severity":"一般","trigger":"连续 2 个计划日缺少完整早晚日记","owner":"CRC","action":"提供设备、网络、语言或无障碍支持；不追问既往症状。"},{"id":"ediary-four","mode":"eDiary","code":"EDI-MISS-04","title":"连续 4 日未完整记录","severity":"重大","trigger":"连续 4 个计划日缺少完整日记","owner":"CRC / PI","action":"1 个工作日内完成中性联系并保留支持证据。"},{"id":"ediary-week","mode":"eDiary","code":"EDI-END-01","title":"主要终点数据风险","severity":"重大","trigger":"治疗期累计 3 个计划日缺失或任一周少于 4 个完整日","owner":"PI / DRM","action":"纳入 DRM 的数据质量审查；不自动停药或退出。"},{"id":"med-record","mode":"eDiary","code":"MED-REC-01","title":"用药记录需要盲态对账","severity":"一般","trigger":"连续 3 日漏记研究药、预设依从性阈值以下或三类用药记录冲突","owner":"CRC / PI","action":"先核对技术、时区与时间线；不根据症状推断未服药或自行改变背景药。"},{"id":"blind-breach","mode":"盲态与治理","code":"BLD-INC","title":"潜在盲态或同意风险","severity":"紧急","trigger":"潜在盲态泄露、撤回同意后仍有提醒或无同意程序","owner":"PI / QA","action":"当天隔离信息并进入独立安全/盲态事件路径。"}],"constraints":[{"code":"PK-01 → PK-04","title":"每人最多 4 次额外 PK 采血","detail":"首剂后一个早期窗口、第 7 天给药前 / 后窗口及第 14 天或末次访视给药前窗口；实际给药、进食和采血时间记录至分钟。"},{"code":"7D · 3D · 1D · DAY-OF","title":"预约与日记提醒有节制","detail":"PK 访视按受控提前量支持；eDiary 同一条目每日最多 3 次自动消息，不以提醒诱导改药或回忆补填。"},{"code":"SCHEDULED → RESOLVED","title":"状态不改写源数据","detail":"任务仅按预定义状态迁移并保留审计痕迹；“已解决”不等同于缺失数据恢复、样本有效或获得临床获益。"}]}