General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contents1. Methodologies for Research and Evaluation of Herbal Medicines
Open this folder and view contents2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Open this folder and view contents3. Clinical Research
Close this folder4. Other Issues and Considerations
View the document4.1 Pragmatic Research Issues
View the document4.2 Ethics
View the document4.3 Education and Training
View the document4.4 Surveillance Systems
View the documentReferences
Open this folder and view contentsAnnexes
Open this folder and view contentsAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Open this folder and view contentsAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Open this folder and view contentsAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Open this folder and view contentsAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Open this folder and view contentsAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Open this folder and view contentsAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Open this folder and view contentsAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Open this folder and view contentsAnnex VIII. Guideline for Good Clinical Practicea
Open this folder and view contentsAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
View the documentAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

4.4 Surveillance Systems

According to the situation of traditional medicine in a particular country, governments may need to establish national surveillance systems at different levels of the health sector to monitor and evaluate any adverse effects of traditional medicine. Knowledgeable researchers and practitioners of traditional medicine should be consulted during the development of such systems.

The evaluation of adverse effects needs to be based on appropriate methods of determining causality. Such methods include instruments to determine adverse events experienced by target groups (patients and practitioners), prospective and retrospective studies to determine adverse effects in specific settings, and post-market surveillance of new devices (both herbal medicines and equipment used in traditional procedure-based therapy) where comprehensive evaluation of any adverse effect is documented.

 

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