In 2001, when the Clinical Trial Directive 2001/20/EG was released in the European Union, Article 15 stated the regulations and legislation for government inspections of trial sites to be implemented by the Member States. The competent authorities of the Member States shall verify protection of the rights and welfare of trial subjects, compliance with the provisions of good clinical practice and the quality of data generated in clinical trials by appointing inspectors to inspect the sites concerned with any clinical trial. The European Medicines Agency (EMEA), which needs to be informed about the inspections, shall coordinate them. The inspections are performed on behalf of the European Union; the results should be accepted by all Member States. In Germany, authorisation of inspections is detailed in the German Drug Law and the corresponding GCP ordinance. The BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is the responsible German regulatory authority. The UK competent authority is The Medicines and Healthcare products Regulatory Agency (MHRA).
In the US inspections are regulated by the Food and Drug Administration (FDA). The specific instructions for inspecting Clinical Research Organisations (CROs) are given in the Bioresearch Monitoring Compliance Program No. 7348.810.
What is an ‘inspection’? The definitions given in the different regulations are very similar. The ICH GCP Guidelines §1.29 [1] state:
‘Inspection’: the act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organisation’s (CRO’s) facilities, or at other establishment deemed appropriate by the regulatory authority(ies).
Inhaltsverzeichnis (Table of Contents)
- Abbreviations
- 1 Coursework Assignment / Section 4 Global Regulations and Inspections.
- 2 Selection of Title
- 3 Introduction
- 4 Purpose of government inspections for GCP
- 5 Preparation programme for inspections
- 5.1 Permanent preparation programme for inspections
- 5.2 Specifics for preparation prior to an announced inspection
- 5.3 Specifics to immediate preparation for an 'for cause' inspection
- 6 Improvements
- 7 Summary
- 8 References
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This coursework assignment aims to discuss the purpose of government inspections for Good Clinical Practice (GCP) within a Clinical Research Organisation (CRO) context. It explores the preparation programmes for inspections and proposes improvements aligned with current expectations.
- Purpose of Government Inspections for GCP
- Preparation Programmes for Inspections
- Global Harmonisation of Regulations
- Efficient Management of Audit Processes
- Improvements for Inspection Readiness
Zusammenfassung der Kapitel (Chapter Summaries)
- Abbreviations: This section provides a list of abbreviations used throughout the coursework assignment.
- 1 Coursework Assignment / Section 4 Global Regulations and Inspections: This chapter introduces the assignment's scope and context, focusing on global regulations and inspections related to GCP.
- 2 Selection of Title: This section outlines the chosen title for the assignment, focusing on the purpose of government inspection for GCP and preparation programmes within a CRO.
- 3 Introduction: This chapter provides an overview of the legal framework surrounding GCP inspections in the European Union, Germany, and the United States. It defines the concept of "inspection" according to ICH GCP Guidelines.
- 4 Purpose of government inspections for GCP: This chapter elaborates on the primary objectives of government inspections for GCP, including the protection of trial subjects, compliance with regulations, and ensuring data quality.
- 5 Preparation programme for inspections: This chapter delves into the different aspects of preparing for inspections, including permanent preparation programmes, specifics for announced inspections, and immediate preparation for "for cause" inspections.
Schlüsselwörter (Keywords)
The keywords and focus topics of this coursework assignment include Good Clinical Practice (GCP), government inspections, Clinical Research Organisations (CROs), global harmonisation of regulations, audit processes, and preparation programmes for inspections. The work examines the purpose and impact of government inspections within the context of GCP, emphasizing the importance of compliance, data quality, and regulatory frameworks.
- Citar trabajo
- Konstanze Frank (Autor), 2004, Global Regulations and Inspections - Research Quality Assurance, Múnich, GRIN Verlag, https://www.grin.com/document/41154
