Spring 2007
A Study Coordinator’s Perspective on Clinical Trials
Presented by Mrs Ruth Carter, British Liver Disease Clinical Research Network (BLDCRN)
Abstract
Aims and objectives of the presentation
The aim of this presentation is to look at the reality of working in a Clinical Research Facility in a busy Teaching Hospital, and the need for defined roles and responsibilities within research.
Outline of the presentation
‘Research is essential to the successful promotion and protection of health and wellbeing, and also to modern, effective health and social care services. At the same time, research can involve an element of risk, both in terms of return on investment and sometimes for the safety and wellbeing of the research participants. Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and social care. The public has a right to expect high scientific, ethical and financial standards, transparent decision making processes, clear allocation of responsibilities and robust monitoring arrangements.’ (1)
‘Good Clinical Practice (GCP) is an ethical and scientific quality standard for designing, conducting recording and reporting trials that involve participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well being of trial subjects are protected consistent with the principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible.’ (2)
As the volume of research being carried out within the NHS setting increases, so the roles of site staff within the studies expands. The roles and responsibilities of key personnel within studies are now defined in the Research Governance Framework 2005. With the introduction of the Medicines for Human Use (Clinical Trials) Regulations in 2004, (and the subsequent amendment in 2006 incorporating ICH GCP), these responsibilities are now set out in EU legislation and UK Regulations.
Roles and Responsibilities
Sponsor – Any project taking place involving NHS patients, staff, tissue samples, data and/or premises must have a nominated sponsor taking overall responsibility for the project before it commences. A sponsor can be the organisation, public body, charity or university who will take overall responsibility for the initiation, management and financing of a project. The sponsor must ensure that the appropriate arrangements and standards are put in place and monitored throughout the duration of the project.
Funder – The organisation providing funding for the study through contracts, grants or donations to an authorised member of either the employing and/or care organisation. The main funder is also responsible for ensuring the scientific integrity of the study and the quality of the study’s science, research environment; experience and expertise of Chief Investigator, co-investigators and other researchers; value for money & the involvement of a sponsor before the research begins.
Chief Investigator – Every study has one designated Chief Investigator who takes overall responsibility for all the initiation, management and monitoring of the study and safeguards all those involved in the research.
Principle Investigator – This is a nominated local investigator conducting the research in a particular site that has been delegated with specific research responsibilities including initiation, management and monitoring.

Investigator – A person responsible for the conduct of the trial who is qualified by education, training and experience to assume responsibility for the proper conduct of the trial.

NHS Research Ethics Committee – are responsible for providing an independent expert opinion about whether a proposed study is ethical and respects the participant’s dignity, rights, safety and well-being. Any research project conducted with NHS patients, staff, data, tissue samples and/or premises must have the prior approval of a recognised NHS Research Ethics Committee (REC).
Although these roles are defined, the roles of other site personel boundaries are not so clear, and in reality who carries out these roles and when does one stop and another begin?
The main issue is that everyone involved in research with human participants, their organs, tissue or data is responsible for knowing and following the law and the principles of good practice relating to ethics, science, information, health and safety, and finance. All those involved in research also have a duty to ensure that they and those they manage are appropriately qualified, both by education and experience, for the role they play in relation to any research. They must be aware of, and have ready access to the right sources of information and support in undertaking that role.
References:
1. Research Governance Framework for Health and Social Care Second edition, 2005
2. Department of Health ICH Harmonised Tripartite Guideline for Good Clinical Practice 1996