For a thorough consideration in the field of Good Clinical Practice (GCP) the first title was chosen:
Evaluate how the personnel in key roles in your organisation demonstrate fulfilment of their responsibilities as required by either GMP, or GCP, or GCP(v), or GLP. Propose one improvement in this respect, with a reasoned argument, for each role.
With respect to the Standard Operating Procedures (SOPs) of my company, to my employment contract, and to my confidentiality statement I am not allowed to notify third parties of any real or assumed deficiencies within my organisation. Therefore, GCP key personnel and their key functions are identified according to applicable regulations (please refer to Section 7 References). Based on the example of a common German Clinical Research Organisation (CRO) working in the field of Phase I trials duties and fulfilment of responsibilities are discussed. Additionally, only presumed or theoretical deficiencies and their improvement are specified.
However, please let me re-emphasise that all facts below are based on regulatory requirements and my experiences but do not allow any conclusions to the operational state of my organisation and to any current or former deficiencies.
Inhaltsverzeichnis (Table of Contents)
- Selection of Title / Statement of Anonymisation
- Introduction
- Responsibilities of Non-CRO Personnel in Key Roles
- Independent Ethics Committee (IEC)
- Regulatory Authorities / Agencies
- Sponsor
- Fulfilment of the Responsibilities of CRO Personnel in Key Roles and Proposal of Improvements
- Project Manager
- Investigator / Sub-investigator
- Project nurse
- Data Manager / Statistician
- Medical Writer
- Quality Control (QC)
- Quality Management (QM), (optional, no GCP requirement)
- Quality Assurance (QA)
- Conclusion
- References
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This document analyzes the responsibilities of key personnel involved in clinical trials, focusing on how these roles are fulfilled within a Clinical Research Organisation (CRO) in the context of Good Clinical Practice (GCP). The document aims to evaluate these responsibilities against existing regulations and propose improvements to existing practices within the CRO.
- Fulfilment of responsibilities by key personnel in a CRO.
- Evaluation of current practices against GCP regulations.
- Proposal of improvements to existing practices within the CRO.
- Identification of essential documents and records in GCP.
- Control and management of essential documents and records within the CRO.
Zusammenfassung der Kapitel (Chapter Summaries)
- Selection of Title / Statement of Anonymisation: This section introduces the chosen title for the coursework assignment, which focuses on the evaluation of personnel responsibilities within a CRO in relation to GCP. It also clarifies the anonymization of the organization and the use of hypothetical situations for evaluation.
- Introduction: This section provides a general overview of the roles involved in conducting clinical trials, including the sponsor, CRO, regulatory agencies, and the Independent Ethics Committee. It highlights the importance of volunteers/patients in the process and emphasizes the need for fulfilling GCP guidelines.
- Responsibilities of Non-CRO Personnel in Key Roles: This section outlines the responsibilities of personnel who are not part of the CRO but are essential to the clinical trial process. It includes the Independent Ethics Committee, regulatory authorities/agencies, and the sponsor.
- Fulfilment of the Responsibilities of CRO Personnel in Key Roles and Proposal of Improvements: This section examines the responsibilities of specific roles within a CRO, such as Project Manager, Investigator/Sub-investigator, Project Nurse, and Data Manager/Statistician. It evaluates how these roles are fulfilled according to GCP regulations and proposes improvements for each role.
Schlüsselwörter (Keywords)
This document focuses on Good Clinical Practice (GCP), Clinical Research Organisation (CRO), key personnel roles, responsibilities, regulations, evaluation, improvements, essential documents and records, control and management systems.
- Quote paper
- Konstanze Frank (Author), 2004, Research Quality Assurance, Munich, GRIN Verlag, https://www.grin.com/document/41152