Conducting GCP- Compliant Clinical Research
A Practical Guide
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Beschreibung
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk andGraham Ball Good Clinical Research Practices, UK and Canada Theoverall aim of this work is to provide a reference book whichdescribes the general framework for conducting GCP-compliantclinical research, particularly pharmaceutical industry clinicalresearch. Wendy Bohaychuk and Graham Ball run a consultancy, GCRPLtd., which has conducted over 820 GCP audits involving more than200 companies in the last 10 years. More than 5,000 individualshave been involved in their training courses to help people performGCP-compliant clinical research. They have authored several booksand articles including:
* Standard operating procedures for investigators
* Standard operating procedures for sponsors and CROs
* GCP - an indexed reference
Drawing on their wealth of experience, they have produced thisenlightening and practical reference work which fills aneducational gap in the understanding of GCP at all levels. Writtenin concise language simple enough to be accessible to those new inthe field, the dozens of real-life stories and detailed casestudies at the end of each chapter make the book an invaluableresource for the more experienced, highlighting what can go wrongin a clinical study: A study of prostate cancer in the UK - Aninvestigator brochure was not provided. The company argued that abrochure was unnecessary because the drug was already marketed.Indeed it was - for hypertension! A study of cardiovascular surgeryin the UK - The consent dates were changed (by overwriting) toindicate that the patients had provided consent before the studystarted. The original dates post-dated the start of the study. Astudy of hypertension in Germany - The investigator brochurepredated the study by nine years! Checklists are providedthroughout the book to help monitors, auditors and investigatorsensure that nothing important is overlooked. The authors presentthe topic of GCP with remarkable clarity, insight and enthusiasmemphasizing that this code of practice was not designed to makestudies more difficult for investigators or more expensive forsponsors and CROs but, in the final analysis, to ensure the safetyand well-being of study participants and future patients who willbenefit from well-conducted, GCP-compliant studies.
Autor*in
Wendy Bohaychuk
Themen in »Conducting GCP- Compliant Clinical Research«
Arzneimittelprüfung GCP-Regeln Klinische Prüfung Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin