Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 7 Issue 4 (July 2000).

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

"Why can't GCP be fun?"
by Wendy Fletcher-Cooke

Abstract
SmithKline Beecham needed to provide training on the International Conference on Harmonisation (ICH) good clinical practice (GCP) guidelines and decided to use computer-based learning (CBL). The challenge facing the team was to turn out a CBL programme that was stimulating and fun to use. This article addresses the exploration of the ICH GCP guidelines and the cartoon-style CBL programme. A discussion of the subsequent variety of uses of the programme and preliminary end-user feedback provides a perspective of its success.

"Innovative writing techniques for regulatory submissions"
by Patsy Higgins and Mark Hovde

Abstract
There is intense pressure on medical writers in pharmaceutical companies to maximise the use of their time to prepare high quality regulatory submission documents, which are key to winning regulatory approval. Parallel authoring systems can help medical writers make the right impression by allowing them to concentrate their valuable intellectual time on original writing activities; rather than the laborious rewriting and checking activities used in the traditional single author, single document model.

"Building a professional investigative site"
by Dr Nancy Stark

Abstract
The number of investigators entering into agreements with the clinical research industry is growing exponentially. Although they may be competent clinicians, these new investigators are experiencing difficulties because they do not understand the purpose of meta-data or the time commitments involved. Hiring a coordinator, preparing standard procedures and training your study staff will go a long way to bringing your investigative site up to professional standards.

" Potential benefits of the CTD efficacy: a regulatory point of view"
by Dr Francoise de Cremiers

Abstract
Dr Fran�oise de Cremiers addresses the current status of the clinical part of the CTD guidelines handled by the efficacy working group and discusses the benefits expected by industry.

"Building a relationship with your IRB/IEC"
Investigator series. Adapted from the article by A van Vliet et al. GCPJ, Vol7, number 1, pp.14-18.

Abstract
The basis of the investigator's relationship with the IRB/IEC is his relationship with each trial subject.