Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)
Table of Contents
View the documentFOREWORD
Open this folder and view contents1. INTRODUCTION
Open this folder and view contents2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
Close this folder3. RESEARCH STUDIES
View the documentLITERATURE BACKGROUND
View the documentPROTOCOL PREPARATION
View the documentQUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATION
Open this folder and view contentsNON-CLINICAL STUDIES
Close this folderCLINICAL TRIALS USING HERBAL MEDICINES
View the documentCLINICAL TRIAL PROTOCOL DEVELOPMENT
View the documentPHASES OF A CLINICAL TRIAL
View the documentETHICS REVIEW BOARD
View the documentRESPONSIBILITIES OF INVESTIGATORS
View the documentRESPONSIBILITIES OF THE SPONSOR
View the documentDATA MANAGEMENT
View the documentSTATISTICAL ANALYSIS
View the documentREPORTING
View the documentEVALUATION OF HERBAL MEDICINE RESEARCH
Open this folder and view contentsTECHNOLOGY TRANSFER AND EDUCATION
Open this folder and view contents4. USING THE GUIDELINES
Open this folder and view contentsANNEXES
View the documentNOTES
View the documentBIBLIOGRAPHY
View the documentSELECTED WHO PUBLICATIONS OF RELATED INTEREST
 

DATA MANAGEMENT

The aim of record keeping and the handling of data is to gather information from the trial without error in a form that can later be analysed and reported. A Case Report Form (CRF) for each patient in the trial must be completed and signed by the investigator and the patient’s files, CRFs and other sources of primary data must be kept for future reference. Patient data must be handled in a way that maintains confidentiality and yet ensures accuracy. All efforts should be made to maintain error-free records.

When subjects are randomized to different groups, the randomization procedure used must be documented. In the case of a blinded trial, a code for the medicine actually administered must be kept under appropriate conditions.

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