Clinical audit

The Clinical Audit in Pharmaceutical Development, edited by Michael R. Hamrell... 

Prasad AN, Penney S, Buckley DJ. The role of vigabatrin in childhood seizure disorders results from a clinical audit. Epilepsia 2001 42(1) 54-61. 

Newman WD, Tocher K, Acheson JF. Vigabatrin associated visual field loss a clinical audit to study prevalence, drug history and effects of drug withdrawal. Eye 2002 16(5) 567-71. 

Post-marketing surveillance studies, pharmacoeconomic studies, non-interventional trials, clinical audit programmes and the like, which have been commissioned, undertaken or provided by companies, must never be promotional in nature and must be conducted primarily with a scientific or educational purpose. This clause does not preclude the use of the data generated from such studies to support claims in promotion. 

Knowledge on the use of a test or intervention ultimately has to be placed in the context of a clinical and economic accountability framework and ensuring the highest quality and lowest risk to patients. Clinical audit is a key element of meeting this objective. 

The term "audit is associated with a particular connotation in healthcare, namely clinical audit and refers to the review of case histories of patients against the benchmark of current best practice. The clinical audit was proposed as a tool to improve clinical practice and a recent study indicates that it can do so, though the effects are modest. A more general role for audit, however, is that it can be used as part of the wider management exercise of benchmarking of performance with the use of relevant performance indicators against the performance of peers. 

Bohaychuk W, Ball G. 1999. GCP compliance assessed by independent auditing international similarities and differences . In The Clinical Audit in Pharmaceutical Development, Hamrell M (ed.). Marcel Dekker New York. 

Bohaychuk W, and Ball G (2000), GCP Compliance Assessed by Independent Auditing. International Similarities and Differences, In The Clinical Audit in Pharmaceutical Development, edited by M Hamrell. (Marcel Dekker publishers)... 

Taylor, R, Burridge, J.H. et al Clinical audit of 5 years provision of the Odstock dropped foot stimulator, Arfx/i Organs 23 440-442,1999. 

Lessons learnt from clinical audit werenotfedbacktofrontlinehealthcare teams. There was a poor risk assessment culture. Risk assessments were viewed by staff as a tick box exercise. 

Diep, R. R, Lien, L., and Hofman, J., A criteria-based clinical audit on the case-management of children presenting with malaria at Mangochi District Hospital, Malawi, World Hosp Health Serv 43(2) 21-29,2007. 

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