E-DRUG: Draft Manuscript for Good Clinical Research Practice
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A draft manuscript "Handbook for Good Clinical Research Practice (GCP):
Guidance for implementation" is available at
http://www.who.int/medicines/ in the "Latest"
This text is as an adjunct to WHO's "Guidelines for good clinical
practice (GCP) for trials on pharmaceutical products" (1995), and is
intended to assist national regulatory authorities, sponsors,
investigators and Ethics Committees in implementing GCP for
industry-sponsored, government-sponsored, or investigator-initiated
clinical research. It is an educational tool to facilitate the
understanding and implementation of GCP.
As part of the global consultation process in the development of this
document WHO welcomes any comments on this draft. We should value your
input before the end of September in order that we may keep to our
time-frame of publishing this document before the end of the year.
Dr M R Couper
Medical Officer,
Quality Assurance and Safety of Medicines
Medicines Policy and Standards
World Health Organization
Tel: +41 2279 13643/12337
Email: couperm@who.int