Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 5 Issue 6 (November/December 1998).

Copies of back issues and individual articles are available direct from the publisher � please contact us for further information.

"The right(s) of the subject in clinical trial-related injury"
by Genevieve Decoster and Martine Wahl

Abstract
The responsibilities of the sponsor with regard to compensation for trial-related injury or death are defined, according to ICH and the Declaration of Helsinki. Legal aspects of clinical trial insurance are discussed. A survey of the information contained within the informed consent (patient information) form is described. Only 17% of forms contain complete, accurate and comprehensive information. Other forms contain misleading, inaccurate, incomplete or inconsistent information. Not enough attention is paid to the rights of research subjects to compensation in trial-related injury or death.

"On trial"
by Lesley Cartwright-Taylor

Abstract
The historical use of prisoners as subjects is discussed. The prevalence of mental disorders is much higher among inmates than among the general population. Drug misuse is a major ongoing problem in the prison system. ICH defines people in detention as a vulnerable subject group, thereby raising ethical issues of consent when using prisoners as trial subjects. Awareness of GCP is almost non-existent among prison healthcare professionals. There are problems with source data verification, tracking subjects and re-recruitment, as well as access to specialist laboratories and equipment.

"Audit Reporting"
by Nigel Crossland

Abstract
The ICH-GCP guidelines on audits and audit reports are defined. A standard format is suggested, along with classifications of audit findings, remedial actions and subject areas. The written response is considered, along with suggested recipients and the importance of confidentiality. The qualities of a good auditor are discussed.

"Can clinical trials in Japan survive within global harmonisation?"
by Hiroshi Sugii

Abstract
The current situation in Japan is discussed, in the light of the recent implementation of ICH-GCP guidelines. Characteristics of the new GCP are highlighted and potential problems are considered from the sponsor's viewpoint. New approaches for solving these problems include better collaboration with CROs, a clinical research co-ordinator system, inclusion of foreign data and effective use of new authorities.

"Over the counter"
Fiona Jones interviews John Simpson, the director of Worldwide Regulatory Compliance at SmithKline Beecham Consumer Healthcare Research & Development

Abstract
John Simpson, Director of Regulatory Compliance at SmithKline Beecham Healthcare, talks about his current position and duties. He outlines the challenges involved in ensuring GCP compliance on both sides of the Atlantic, and the benefits and drawbacks of using external consultants. He also discusses the company's training programmes which help to motivate staff and achieve a universal compliance culture.