T/CACM 1420-2022 Active

Scope: This document specifies the requirements for evaluating the placebo simulation effect in the clinical research of traditional Chinese medicines, including recommended evaluation items and evaluation reports. This document is applicable to professionals engaged in the clinical evaluation of traditional Chinese medicines for assessing the clinical efficacy and safety of drugs. Main technical contents: Foreword II Introduction III 1 Scope 12 Normative reference documents 13 Terms and definitions 14 Evaluation of the placebo simulation effect 34.1 Overview 34.2 Evaluators 34.3 Evaluation content 34.4 Evaluation methods and pass/fail criteria 45 Recommended evaluation items 76 Evaluation reports 77 Others 7 Appendix A (informative) Three-point test correct response value critical value table 9 Appendix B (informative) Questionnaire for evaluating the placebo simulation effect of traditional Chinese medicines (independent evaluation) 10 Appendix C (informative) Questionnaire for evaluating the placebo simulation effect of traditional Chinese medicines (scoring evaluation) 11 Appendix D (informative) Questionnaire for evaluating the placebo simulation effect of traditional Chinese medicines (three-point test) 13 References 14