ICS19.020 CCSC19 TB 广东省食品药品审评认证技术协会团体标准 T/GDFDTAEC10-2025 特应性皮炎药物临床试验疗效评价操作技 术规程 Operationaltechnicalproceduresforevaluatingtheefficacyofatopicdermatitis drugsinclinicaltrials 2025-10-21发布2025-10-21实施 广东省食品药品审评认证技术协会  发布 全国团体标准信息平台 目录 前言............................................................................................................................................................................1 1范围........................................................................................................................................................................3 2规范性引用文件.................................................................................................................................................3 3名词术语...............................................................................................................................................................3 4评价程序...............................................................................................................................................................4 4.1评估指标确认.........................................................................................................................................4 4.2评估主体要求.........................................................................................................................................6 4.3评估客体要求.........................................................................................................................................7 4.4评估前准备.............................................................................................................................................7 4.5评估过程要求.........................................................................................................................................8 5信息记录和档案管理.....................................................................................................................................10 5.1图片资料存档......................................................................................................................................10 5.2档案管理................................................................................................................................................10 6特应性皮炎背景治疗——润肤剂的使用................................................................................................10 6.1润肤剂类型...........................................................................................................................................11 6.2润肤剂的选择......................................................................................................................................11 6.3润肤剂的使用......................................................................................................................................11 7特应性皮炎皮损部位拍摄............................................................................................................................13 8儿童特应性皮炎临床试验管理注意事项................................................................................................13 8.1知情同意................................................................................................................................................13 8.2儿科专业知识......................................................................................................................................13 8.3全面考虑安全问题.............................................................................................................................14 9特应性皮炎受试者日常管理.......................................................................................................................14 9.1皮肤护理................................................................................................................................................14 9.2药物管理................................................................................................................................................14 9.3触发因素管理..................................