Standard operating procedures for clinical investigators

Overview

By Juntra Karbwang and Claire Pattou

Publication details

Publication date: 1999
WHO reference number: TDR/TDP/SOP/99.1
Number of pages: 36
Languages: English

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Summary

All clinical studies supported by TDR must be carried out according to International Conference on Harmonisation (ICH) / WHO Good Clinical Practice standards, regulatory authorities requirements, and TDR Standard Operating Procedures (SOPs).

This document sets out the objectives of Standard Operating Procedures and defines the Investigators' responsibilities when undertaking a clinical study supported by TDR. It provides instructions for planning, performing, documenting and reporting clinical studies, and also provides a useful glossary of terms.

Latest version: Workbook for investigators. Section 2