Good Clinical Practice Journal

Below are the titles of articles published in the Good Clinical Practice Journal Volume 6 Issue 2 (March/April 1999).

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"What does the EC Directive currently state about ADR reporting?"
by Anthonia Chalmers

Abstract
The progress of the EU Directive on clinical trials is outlined. The article focuses on ADR reporting, and reproduces the exact wording of the relevant chapters of the Directive. Some important amendments have been made, while other definitions have been left unchanged. Several guidelines have been proposed to complement various aspects of the Directive, and these too are detailed.

"Clinical trial monitoring in Spain: facts and perspectives"
by V Alfaro, M Prats, J Nadal and M Alami

Abstract
The present status and the future perspectives of clinical trial monitoring in Spain were assessed by means of an anonymous questionnaire distributed to the staff of medical, clinical research and R&D departments of the main pharmaceutical companies operating in Spain. The results revealed the following profile of clinical research assistants (CRAs) and monitors in Spain: an individual, preferably with academic degree in Health Sciences (64.4%) or Basic Sciences (35.6%), who mainly monitors Phase III clinical trials (50.2%), visiting 11-20 sites and monitoring 51-100 subjects per year. The mean number of clinical trials monitored by one person in one year was 4 ± 2. These results seem to confirm the relevance of monitors/CRAs in the success of clinical trials in Spain.

"The EU Directive and commercial research"
by Dr Jean-Pierre Tassignon

Abstract
Principles of GCP are now being applied to clinical research world-wide. The initial "soft" interpretation of GCP in the European Union (EU), has led to variable levels of implementation of GCP across the industry. Regulatory authorities are likely to enforce compliance using three methods: regulation, inspection and accreditation. The nature of sponsors and CROs running clinical trials is to adapt and comply with regulations in areas of the world where this is possible, and avoid those regions, where they cannot comply. . Complex regulatory environments are therefore not a deterrent per se preventing the continued expansion of clinical R&D in Europe. But, Europe is, and will remain, a GCP-puzzle, where not a single aspect of GCP functions in the same way everywhere. The Directive will not, and cannot, change this. With their high levels of patient recruitment and clean data, the impact of the CT Directive will be a further progression of trials in Eastern Europe.

"Efficient monitoring using central centre co-ordinators"
by Dr François Geelen

Abstract
Efficient centre performance can conserve the sponsor's resources. Trial centres require management as part of monitoring. The centre initiation establishes a first level of trial organisation within the centres. Inconsistencies between centres arises from differences in organisational structure and trial experience. A clearly identifiable element in this respect is the centre co-ordinator. Another inconsistency arises when a trial is initiated and monitored by more than one monitor. Resources may be saved by investing in proper trial preparations, especially in the organisational aspects. Special tools such as centralised centre management can be developed, especially for monitoring trials in geographically inefficient situations. Central centre co-ordinators responsible for several centres have proven to be effective in managing the consistency of centre quality.

"Interview with Dr Kathryn Huntley - the face of MedDRA"

Abstract
Dr Kathryn Huntley talks about the MedDRA project, the teams involved, the support services and budgetary implications for companies. She describes how language differences and national barriers will affect the terminology, and outlines the involvement of the various regulatory agencies, and the processes by which a new term may be included in the dictionary.