Auditing Safety-Related Processes and Procedures: Lessons Learned for Global Compliance and Quality
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Goldman
fully negotiating this difficult task, lessons learned based on performance of premarketing clinical safety and pharmacovigilance (CSP)-related audits internationally (including in the United States and European Union) are offered here. As deficiencies and other findings have been common among companies and the desired outcomes of CSP-related SOPs across countries and regions are quite similar, the observations offered are globally applicable to all types of regulated medical products.
corporates visits to the site where the clinical trial is being carried out. In contrast, a premarketing clinical safety audit is perhaps best characterized as a systematic and independent examination of safety- related activities (eg, investigator reporting of serious adverse events [SAEs]; SAE causality assessments performed by investigators and company safety personnel) and documents (eg, completed SAEforms; submitted fi-day investigational new drug [IND] safety reports;annual reports) to determine whether the ...trial safety data were recorded, analyzed and accurately reported according to the protocol, sponsor's SOPs . . . and the applicable regulatory requirement(s) (2;italics and parenthetical material added)
G O O D CLINICAL PRACTICE VERSUS P R E M A R K E T l N G C L I N ICA L S A F E T Y It is important to distinguish between good clinical practice (GCP) and assessment of how companies perform premarketing clinical safety. The ICH Topic E6 "Guideline for Good Clinical Practice" was developed in consideration of EU, Japanese, and US applicable practices, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (2). Adopted by all three regulatory parties to ICH (European Agency for the Evaluation of Medicinal Products; Ministry of Health, Labour, and Welfare; and FDA), the guideline provides the following GCP definition: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and re-
porting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (2)
An audit is defined as follows: A systematic and independent examination of trial
related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs). good clinical practice (GCP), and the applicable regulatory requirement(s). (2)
In focus and manner of performance, a GCP audit differs significantly from a premarketing clinical safety audit. The former entails evaluation of the range of trial-related activities and documents covered by GCP and customarily in-
The safety auditor generally does not visit clinical trial sites but rather performs a site visit to the office where the safety department personnel are located and evaluates their SOPs, computerized system
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