Roles and Responsibilities of the Trial Team
Randomised controlled trials are large projects which require formalised management. Multi-disciplinary teams are essential for their successful design, planning and delivery. Each trial requires clinical, methodological and trial management expertise. Trial staff at each participating site are also essential to ensure effective recruitment and delivery according to the trial protocol. The roles and responsibilities of each member of the team must be clearly defined and documented to ensure clarity; thus minimising risk to participant safety and data credibility.
Certain roles may be termed differently from one clinical trials organisation to another or from one country to another (for example in the UK we have a chief investigator, but outside of the UK this role is often termed co-ordinating investigator or investigator), or specific responsibilities may fall into different roles across different organisations. However, the list below provides an overview of the types of roles and responsibilities required to ensure a successful trial. Depending on sources of funding, specific roles may be employed for a single trial only, or employed as part of a team working on multiple trials.
The sponsor of a randomised controlled trial is the person or organisation which takes responsibility for the overall management and financing of a trial. The sponsor is responsible for ensuring that a trial complies with the legislation and with Good Clinical Practice (GCP). Examples of sponsor organisations include commercial companies such as pharmaceutical companies, academic organisations such as Universities, or employers of Chief Investigators such as NHS trusts in the UK. The sponsor can formally delegate one or more of the functions of sponsorship. For example a pharmaceutical company may employ a contract research organisation (CRO) to perform monitoring or trial management activities, but the sponsor remains accountable for all functions of sponsorship even when these functions are formally delegated.
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(Outside of the UK, this role may be referred to as the Co-ordinating Investigator or Investigator.) The Chief Investigator (CI) is the lead researcher on the trial. With the input of statisticians, programmers, trial management staff and other experts, the CI will take responsibility for the design, conduct and reporting of the trial. The CI is usually an authorised healthcare professional such as a medically qualified doctor or dentist. For multi-national trials, one CI will be appointed for the trial per country.
The Chief Investigator (CI) will ensure that for each site delivering the research, an authorised healthcare professional is appointed to take responsibility for the conduct of the trial at that site. This authorised healthcare professional is called the Principal Investigator (PI). The CI can also act as a PI at a trial site. The PI will often be supported by a team to whom the PI may delegate trial related duties.
Research nurses specialise in the delivery and management of clinical trials at trial sites. They are often part of a team which will be led by the Principal Investigator and will usually be involved in the recruitment and consent of trial participants, and in the conduct and organisation of trial related procedures in compliance with the trial protocol. The tasks taken on by a research nurse will be authorised by the Principal Investigator. These tasks may include the collection, documentation and management of the data; conduct of trial related clinical procedures; delivery of the intervention; reporting of safety events (that have been reviewed by the Principal Investigator) to the sponsor; and maintenance of the investigator site file.
Medical Statistician / Biostatistician
Medical Statisticians are responsible for providing statistical and methodological advice throughout the trial lifecycle, assisting with the design, conduct and analysis of the trial. They will perform sample size calculations, write the statistical analysis plan and contribute to the overall design of the trial. They will be heavily involved in writing the corresponding sections of the grant application and protocol, designing the data collection tools and testing the trial database. Statisticians are responsible for the interim and final analysis of trial data and will have a key role in the presentation and publication of results. An individual trial team may include a single senior statistician or a more junior statistician who is supervised by a senior statistician. Within a trial unit or pharmaceutical company there will generally be a team of statisticians with senior or principal statisticians maintaining oversight of a portfolio of trials, negotiating new business, and providing expert advice and mentorship to the junior statisticians in their team.
Alongside determining the effectiveness of an intervention, clinical trials will often also conduct an economic evaluation. A consideration of costs alongside effectiveness is used to inform decision making by organisations who determine what treatments should be endorsed in healthcare systems (for example the National Health Service (NHS) in the UK). Health Economists will be involved in the design of clinical trials to incorporate a health economic component and in the cost analysis of the data collected.
Depending on the nature of the trial, a qualitative researcher may also be part of the trial team. A qualitative researcher will collect and analyse non-numerical data, such as interviews with patients, trial participants or health professionals, recordings of consultations between health professionals and patients, or observations of the delivery of trial interventions. Such methods may be employed prior to the trial (in a feasibility or pilot study) or alongside the trial (for example as part of a process evaluation). Examples of the types of questions that such methods can be used to answer include the identification and solutions to barriers to recruitment into a trial; better understanding of the complexity of the trial interventions, observation of how actual implementation differs from planned implementation to better inform future practice.
The day to day management and organisation of a randomised controlled trial is the responsibility of the Trial Manager/Co-ordinator who is instrumental in the planning and delivery of the trial, maintaining responsibility for ensuring the trial is being delivered in compliance with the protocol and the applicable regulatory requirements. They will set up clinical sites, prepare ethics committee and regulatory submissions and provide training to site staff on the delivery of the protocol. They will maintain oversight of the trial sites and take appropriate action to ensure good recruitment, and the quality and timeliness of the data collection. If staff are employed to work on multiple projects (rather than being funded for a specific trial after funding for the trial has been awarded), the Trial Manager/Co-ordinator may also play a fundamental role in the preparation of new research proposals and be involved in the preparation of costings and grant applications, writing and editing the protocol and the design of data collection tools. In some instances (for example in smaller trials units), the trial manager/co-ordinator may take on additional roles such as quality assurance or monitor if there are no staff employed specifically for those additional responsibilities.
In some trials units / companies staff will also be employed in the role of Senior Trial Manager/Co-ordinator. Such individuals may be responsible for managing a portfolio of trials and the staff working on those projects, in addition to actively co-ordinating individual trials.
Data Manager/Trial Administrator
The Data Manager/Trial Administrator is responsible for the management of the clinical research data that is collected for a trial. This will include ensuring timely returns of the data, entering the data onto the trial database and checking for inconsistencies and incomplete data. The Data Manager will perform regular, systematic checks to validate and verify information on the database(s) in order to produce a clean, accurate and complete set for analysis. In some instances, a Trial Administrator may also have additional responsibilities assisting the Trial Co-ordinator/Trial Manager in their role.
Trial Management Team Lead
Within Clinical Trials Units there are often Trial Management Team Leads, responsible for the delivery of trials within their portfolio and for leading and developing a team of trial management staff. Portfolios may be based on different disease areas or types of trials. They will oversee the management of the clinical trials in their remit, taking an active role in providing specialist trial management advice, contributing to the design and costing of new trial proposals, preparing grant applications and contributing to the presentation and publication of results.
The trial programmer is responsible for the design, development, implementation, and documentation of a number of database applications for trials to record trial data and participant outcome data. Trial Management systems that are used to run randomised controlled trials will be developed using off-the-shelf or bespoke systems built with various web and database server technologies.
Quality Assurance Team
The Quality Assurance (QA) Team are responsible for the development and maintenance of the quality management system (QMS) and for the training of staff on the QMS. A QMS will consist of a number of standard operating procedures and quality control documents which provide the processes that employees in an organisation must follow to ensure that trials are compliant with regulatory requirements and that patient safety and data integrity are respected. The QA team will also implement a programme of quality checks which may include audit to provide assurance of compliance with the QMS. The QA team will work on behalf of an organisation, for example a sponsor organisation, to provide assurance that trials are being conducted in compliance with the legislation and with Good Clinical Practice (GCP).
Clinical Trial Monitor
The sponsor is responsible for ensuring that clinical trials are adequately monitored, that is, ensuring that the trial is being conducted in accordance with the protocol, Good Clinical Practice (GCP) and regulatory requirements. A Clinical Trial Monitor is appointed on behalf of the sponsor to perform the duties required to provide the sponsor with this assurance such as checking data accuracy and ensuring that safety issues have been adequately reported. In industry the term often used to describe this role is Clinical Research Associate (CRA).
Clinical Research Associate (CRA)
The CRA is a role synonymous with the pharmaceutical industry and within CROs. The role of the CRA can vary from one organisation to another. Typically, a CRA acts as a liaison between the trial management team and the trial sites. The main responsibilities of a CRA will be in the monitoring and oversight of the trial to ensure data credibility and protocol compliance. The role of the CRA can therefore be similar to that of the clinical trial monitor. In other organisations, the CRA will in addition set up and close-down clinical trial sites, and may also take on some trial management responsibilities similar to that of a trial co-ordinator/manager. There may therefore be additional project management responsibilities with this role, and this can differ from one organisation to another.
Systematic Review is the process by which studies (such as randomised controlled trials) that have been previously conducted in a particular area are summarised to provide evidence on the effectiveness of healthcare interventions and to identify unanswered research questions. By summarising the research on a topic, they are essential to provide justification and rationale for a future trial and to inform its design. Systematic Reviewers are involved in the conduct of this evidence synthesis prior to the development of an application for funding and development of a protocol. Where possible, at the end of the subsequent trial, they will also update any previous relevant systematic review incorporating the results of the trial, to more speedily inform other researchers and future research.
Public and Patient Involvement (PPI)
Research for patients needs to involve patients, and patient representatives have become an important inclusion in the team responsible for the design and delivery of clinical trials. As well as providing an opportunity to gain the patient perspective on the importance of research to their clinical condition, it is also a chance for practical issues to be identified and protocols to be amended and resolved prior to approval and participant recruitment.
Medical writers work as a part of a scientific writing team which plays a critical role in the communication process of outlining the goals, strategies, analysis, and medical understanding of a clinical trials. The role includes communicating to patients, sites, sponsors, and regulatory agencies and involves the preparation of clinical documents including protocols, clinical study reports (CSRs), and Investigator’s Brochures.
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Introduction to Randomised Controlled Trials
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