Good Clinical Practice Standard Operating Procedures for ClinicalResearchers Edited by Josef Kolman MPRC - Medical PharmaceuticalResearch Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul MengConsultant, Vienna, Austria and Graeme Scott Professional Servicesin Clinical Research, Edinburgh, Scotland There is a growing trendfor investigators to adopt a more formal approach to the proceduresapplied to various stages of clinical trials. Most environmentsemploy some form of standard operating procedures which aredesigned to be used as 'working tools' within that particularfield, e.g. standard operating procedures in hospitals for doctorsand nurses. With rigorous standards of good clinical practice beingapplied to all areas, optimizing the design and use of standardoperating procedures is more in demand every day. Topics coveredinclude:
* A brief description of the history and development of clinicalresearch and good clinical practice
* An explanation of what standard operating procedures are and howthey work
* A selection of actual standard operating procedures andchecklists
This well-constructed and timely work, set out in a logical,sequential order provides the necessary material needed to developa useful set of investigator standard operating procedures.
Josef Kolman
Klinische Prüfung Medical Science Medizin Medizin, Pharmazie / Allgemeinmedizin, Diagnostik, Therapie Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin