Good Clinical Practice (GCP) is the quality standards to which we all work when managing clinical trials. ICH GCP as we all know is the overriding framework that we worked up. And a section 5.1 points out sponsors need to implement and maintain quality assurance and quality control systems to ensure the safety and well-being of trial subjects are protected as well as their legal and ethical rights. the EMA have considered that the number of clinical trials with quality issues is on the increase and our looking to develop some guidance to help sponsors put together risk-based quality management systems within clinical trials this reflection paper is a summary of that thought.

Excerpt from the Reflection Paper

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Good clinical practice (GCP), is a set of internationally recognised ethical and scientific standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
ICH GCP requires in Section 5.1, that the sponsor implements and maintains systems for quality assurance and quality control; similarly the Article 2 of the GCP Directive 2005/28/EC, , requires the implementation of procedures necessary to secure the quality of every aspect of the trial. The aim of those quality management measures is to provide assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The same requirements apply to Contract Research Organisations (CROs), vendors or other service providers to whom the sponsor has delegated any trial related duties and functions of the sponsor. However the sponsor remains responsible for the quality of the trial. The ICH GCP was finalised in 1996 when clinical research was largely paper based, but the available technology and the approach to the conduct of clinical trials has evolved considerably in the meantime.
The key elements of the quality system include:

Documented procedures being developed, implemented and kept up-to-date

Training of sponsor personnel as well as of the personnel in affiliates, at partners and at trial sites

Validation of computerised systems

Monitoring of trial sites and technical facilities on-site or by using centralised monitoring techniques
Data management and quality control

Internal and external audits performed by independent auditors
The current manner in which these quality systems are implemented by sponsors and their agents (CROs etc) are generally acknowledged to be costly and time-consuming, and constitute a major proportion of the cost of development of medicines.
Implementing these processes can be and often is successful in achieving a good quality clinical trial. However it is expensive and there remain too many trials in which avoidable quality problems arise as evidenced for instance by the nature and extent of findings, identified by European GCP inspectors during inspections. The combination of these findings and the very high cost of the processes involved strongly suggest that current approach to clinical quality management is in need of review and reorientation.
A scalable and proportionate approach is required in order to cover the needs of academic researchers, Small and Medium Enterprises (SMEs) and large multinational pharmaceutical organisations.
Sponsors are expected to cope with this challenge and to move towards a more systematic and risk based approach. There is a need to find better ways to make sure that limited resources are best targeted to address the most important issues and priorities, especially those associated with predictable or identifiable risks to the wellbeing of trial subjects and the quality of trial data.
ICH-GCP, e.g. in respect to auditing, already underlines that the sponsor’s audit plan and procedures for a trial audit should be guided by the importance of the trial for submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, by the level of risks to the trial subjects, and any identified problem(s). Similarly the GCP requirements for monitoring indicate that the sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.
With the implementation of ICH Q9 guideline2 as GMP Annex 20 in March 2008, Quality Risk Management has become an accepted standard. This concept can be adapted and described for clinical research with medicinal products.
Thus, the purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.
The activities of other groups in this area (e.g. ADAMON3, ECRIN, OPTIMON8, MRC/DH/MHRA joint project: Risk Adapted Approaches to the Management of Clinical Trials4 and the Organisation for Economic Co-operation and Development (OECD)), the FDA CTTI (Clinical Trial Transformation Initiative), CTFG, GCP IWG and the principles of ICH Q8 Pharmaceutical Development5, Q9 Quality Risk Management2 and ICH Q10 Pharmaceutical Quality System6 have been taken into account in developing this paper.