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Standard Operating Procedures for Clinical Researchers
John Wiley & Sons, 177pp, ISBN 0-471-96936-2.

Published:  April 1998

Editors:   Paul Meng Consultant, PMC, Vienna, Austria.
Josef Kolman, The Medical Pharmaceutical Research Centre, Vienna, Austria.
Graeme Scott Scotia Pharmaceuticals Ltd, Stirling, Scotland, UK.

The ICH guideline for GCP(1) defines the standard to which Investigators must adhere to when conducting clinical trials. It is not a requirement of GCP for Investigators to work according to SOPs. However, many realise that formalising and documenting procedures provides a means to ensure that the rigorous standards of GCP are implemented and maintained. This book was written with the primary aim of providing Investigators with a summary of the information require in order to facilitate the conduct of clinical trials in accordance with the ICH guideline.

The presentation of the book is a selection of SOPs and Checklists, each provided in a clear, concise format that are ready to use but may be amended to provide a customised portfolio of relevant documentation.

The SOPs are presented in a logical order. They follow the flow of a clinical study starting from the organisation and planning required prior to commencing a clinical study, right through to archiving trial data. Areas covered therefore include: reviewing and validated the protocol, obtaining informed consent, managing study drug supplies, reporting adverse events and clinical results, and being prepared for monitoring visits, audits and inspections.

Two sample SOPs are included entitled 'Nursing Procedures' (Application of Nitro-glycerine Ointment) and 'Clinical procedures' (Standardised Measurement of Blood Pressure). These are included to encourage and assist medical and nursing staff to prepare and employ SOPs to cover all practical aspects of the clinical study. In this way the book emphasises the use of SOPs as a training medium for clinical staff.

In addition, the book contains an interesting and brief description of the entire clinical development process including a summary of the basic principles of GCP. The history and development of GCP and the international harmonisation process are all explained clearly and succinctly. A summary of the Investigators responsibilities and the relationships that exist with Pharmaceutical Companies and CROs are also included. In the final chapter, the editors have provided a useful summary of the FDA regulations concerning clinical trials.

The books primary aim is to provide Investigators with a GCP reference source and to supply a database of standard SOPs that may be adapted according to specific requirements. For this function the book excels and should form essential reading for all medical staff conducting clinical trials. In addition, it may be recommended to staff involved in the management or monitoring of human clinical research as an easy-to-use, quick-check summary of the procedures involved throughout the clinical trial process. In particular it provides a useful training tool for CRAs, Study Monitors, Medical and Regulatory Affairs personnel and all involved in preparing and managing SOPs.

  • Reference

1. ICH SECRETARIAT (1996). ICH Harmonised Tripartite Guideline for Good Clinical Practice. IFPMA, Geneva.

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