FAQs
About us
What is a Clinical Trials Unit?
See our ‘About Us’ pages for an explanation of how a Clinical Trial’s Unit is defined.
What is a Pragmatic Clinical Trial?
Information about what a Pragmatic Trial is can be found here
What is UKCRC registration and does PCTU have it?
The PCTU has full registration with UK Clinical Research Collaboration (UKCRC). UKCRC registration is intended to help improve the quality and quantity of expertise involved in implementing clinical trials. In order to achieve UKCRC registration PCTU has demonstrated a proven track record in coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trials coordination.
What areas of research does the PCTU cover?
The PCTU collaborates in studies across many clinical areas but our five strengths are in Colorectal Surgery, Mental Health, Primary Care, Women's Health and Critical Care. We focus on Pragmatic Trials but will consider many other types of trial and other well-designed studies. We have particular methodological strengths in cluster-randomised trials including stepped wedge designs, and pilot and feasibility studies. Further information can be found on our Clinical Strengths and Studies pages and Methodological Strengths and Research pages.
What studies does the PCTU currently collaborate on?
Our Current Studies pages list all the studies and projects we are currently collaborating on. These pages have links to further information about the study and the study teams.
Collaborating with us
What types of studies do the PCTU collaborate on?
Please see our Explore a New Collaboration pages for details of the types of projects we collaborate on.
What should I do if I would like PCTU to collaborate on my project?
Detailed guidance on enquiries process, including how to contact us and when can be found on our Explore a New Collaboration pages.
CTIMPs and PCTU Collaboration
What is a CTIMP and how do I know whether my study is a CTIMP?
A CTIMP is a Clinical Trial of an Investigational Medicinal Product. These typically involve trials of new and experimental drugs but may also include testing existing drugs in patient groups or for alternative indications outside of their approved use. These trials are regulated and approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in addition to your sponsor and the HRA.
Medical device studies that involves CE marked devices that are being used outside their intended purpose or Non-CE marked devices must apply to MHRA for approval which is the UK competent authority for medical devices.
To find out if your trial is a CTIMP study use the MHRA algorithm.
In addition, it is advisable to contact the MHRA to confirm whether your trial is indeed a CTIMP or non-CTIMP trial.
You should also speak with your study sponsor in advance so that may advise you on any specific requirements they may have and to discuss their capacity to support a CTIMP trial.
Does PCTU collaboration in a CTIMP/Device cost more than PCTU collaboration in a non-CTIMP?
The cost of collaborating with the PCTU is calculated individually for each trial. A CTIMP/device trial will require a full time Trial Manager (please see below: Why do I need a full time PCTU-based Trial Manager for my MHRA regulated study?) and additional rigorous auditing and monitoring to ensure safety of participants and compliance to stricter regulations. All these factors may involve additional costs for the PCTU to support the trial. The PCTU makes a fair costing proposal with the study team and sponsor.
If you have any questions regarding our costing processes, please see our Collaboration page for more details.
Costing PCTU Collaboration
How is PCTU collaboration costed?
If the PCTU collaborates on your study, the staff involved will be a Senior Statistician, Statistician, Senior Data Manager, Data Manager, Senior Trial Manager and Quality Assurance Manager. Depending on your study, a Senior Health Economist, Health Economist, Trial Manager/Coordinator and Trial Monitor may also be involved. As part of our unit’s function, all studies will have a small amount costed for PCTU Administration.
Prior to grant submission, the PCTU collaborates with you to develop your study before funding. We will use the information gathered about your study to calculate the % of PCTU staff resources and some consumables (See below: why have PCTU consumable costs been added to my budget and what do they include?) that your study requires. The PCTU will liaise with Queen Mary Joint Research Management office to calculate staff salaries.
The PCTU will provide you with costs for our staff time in a form which we call Collaboration And Financial Form (CAFF). The Collaboration And Financial Form will also have more detailed breakdown about the activity of each staff member collaborating on your study.
Will the PCTU cost my whole study?
The PCTU will only provide costs for the PCTU staff that will be working on your study. You should contact your sponsors R&D office as soon as possible to discuss other costs such as equipment, travel, subsistence and patient costs.
Why have PCTU consumable costs been added to my budget and what do they include?
The PCTU incorporate 10% of staff salaries towards consumables including specialised software, required PCTU staff training, some IT equipment, stationary and printing.
Why do you have to re-cost an application from an outline to full application?
Due to the time elapsed between outline and full application it is essential that the costs are reviewed. Dependent on the feedback you receive from funders, there may also be a need to make changes to costs from outline to full.
Trial Management
What does a Trial Manager/Coordinator do?
The titles of ‘Trial Manager’ and ‘Trial Coordinator’ are used differently by different studies and organisations. In some cases ‘Trial Managers’ are more senior to ‘Trial Coordinators’ but for the most part, the two titles are interchangeable.
Trial Managers/Coordinators are responsible for the day to day management of one or more studies, which are run in accordance with the Good Clinical Practice guidelines. The main responsibilities include:
- Acting as the main point of contact for the study, communicating with investigators, clinicians, stakeholders, sites, funders, ethics and the sponsor
- Coordinating the preparation, collection, review and tracking of essential study documents
- Setting up sites for recruitment activities
- Arranging Trial Management Group (TMG), Trial Steering Committee (TSC) and Data Monitoring Ethics Committee (DMEC) meetings
- Monitoring and reporting on study progress (recruitment, budget, timelines etc.)
- Coordinating any amendment applications
- Creating and maintaining the Trial Master File (TMF)
- Closing the study down and archiving
What does a Programme Manager do?
Programmes consist of a coordinated and coherent group of related projects/studies, focused on a coherent theme, requiring multidisciplinary approaches. Programme grants provide larger, longer term (for example, usually five years for NIHR Programme Grants for Applied Research) and, sometimes, renewable funding.
A Programme Manager oversees the overall efficient day-to-day management of the programme, ensuring co-ordination and joint working across the different projects/studies.
Often, a programme will be also staffed by a Trial Manager/Coordinator and/or Research Assistants who might work on one or more of the projects/studies within the programme. The Programme Manager may supervise these staff.
What does the PCTU Senior Trials Manager Do?
The PCTU Senior Trials Manager has a dual role.
Firstly, they provide operational and specialist support for Trial Managers/Coordinators, providing training and advice as needed. When the Trial Manager/Trial Coordinator is not physically based within the PCTU, the Senior Trials Manager is the main operational liaison between the Trial Manager/Coordinator and the PCTU. The PCTU Senior Trial Manager also monitors the progress of all studies in the PCTU and reports back to the Management and Operational Teams.
Secondly, the PCTU Senior Trials Manager undertakes responsibilities on individual studies. The main responsibilities of the PCTU Senior Trials Manager for each individual study include:
- Collaborating with the study team to develop study materials
- Contributing to the multidisciplinary risk assessment
- Contributing to the development of study management tools (e.g. Gantt charts)
- Advising the study team when key decisions are made during the running of the study e.g. changing timelines
- Troubleshooting recruitment and other study management issues
- Overseeing the work of the trial coordinator, if based at the PCTU
- Attending Trial Management Group (TMG) meetings as required
How does the Trial Manager/Coordinator interact with the study team and the other teams at PCTU?
The study team comprises all those who work on a study. The Trial Manager/Coordinator provides a link between study team staff in the core PCTU team and the rest of the study team. The Trial Manager/Coordinator will usually coordinate and facilitate the Trial Management Group (TMG) meetings which allow core PCTU staff to have regular input into the management of a study. For some processes, the Trial Manager/Coordinator will liaise with an individual within the PCTU over a period of time. For example, when the database is being developed the Trial Manager/Coordinator will be in regular (sometimes daily) contact with the Database Developer and Database Manager to develop the database requirements and to test the database.
The Trial Manager/Coordinator is expected to keep the PCTU up-to-date on study progress and issues. This can be done via the PCTU Senior Trial Manager, or in Trial Management Group (TMG) meetings.
The PCTU also run regular Trial Management Forums, which consist of workshops, presentations and group work. The Forums also provide an opportunity to network and troubleshoot issues. The Forums are open to anyone involved in the management of a PCTU linked study. For more information, please contact the PCTU Senior Trial Manager (PCTU Staff List)
Should I cost a whole-time or part-time Trial Manager/Coordinator into my study?
This depends on a number of factors, including but not limited to; study complexity, study risk, study type (e.g. Clinical Trial of an Investigational Medicinal Product (CTIMP) or non-CTIMP, randomised or observational) study size (i.e. sample size), study duration and number of recruiting sites.
The PCTU has considerable experience of the amount of time needed for study management in different studies and can advise about the management resources that are needed in your study at the pre-submission stage (i.e. before the study is funded).
Where will Trial Managers/Coordinators be based?
This depends on the study, your location, expertise and team. If your study is not being run from Queen Mary University of London (QMUL), or Barts NHS Health Trust, then the trial management will often be based at the sponsoring organisation.
If your study is being run within QMUL or Barts NHS Health Trust, there are advantages in having the Trial Manager/Coordinator directly line managed and mentored by the PCTU Senior Trials Manager, in terms of their interaction and learning from other experienced trial staff and better communication links with the others in the core PCTU teams.
For Clinical Trials of an Investigational Medicinal Product (CTIMPs) it is PCTU policy that a full time Trial Manager/Coordinator is line managed by the PCTU Senior Trials Manager(please see ‘Why do I need a full time PCTU-based Trial Manager for my MHRA regulated study?’)
All PCTU supported studies require a small amount of PCTU Senior Trials Manager time. For more info please read ‘What does the PCTU Senior Trials Manager Do?’.
Why do I need a full time PCTU-based Trial Manager for my MHRA regulated study?
CTIMP and other MHRA governed studies are usually higher risk, they require more procedural management to ensure that they are in line with all regulations and are also subject to intensive inspections by the MHRA. They therefore require an experienced, full-time Trial Manager who can work very closely with the PCTU QA team. Thus the PCTU has a policy that all such studies require a full-time Trial Manager/Coordinator line managed by a PCTU Senior Trials Manager.
This does not mean that non-CTIMPs will never require a full time Trial Manager/Coordinator; some non-CTIMP studies can be just as complex (in terms of management) as non-CTIMPs. Furthermore, the PCTU aims to conduct all studies to the highest quality, not just CTIMPs.
What is a TMF and why do I need one?
A Trial Master File (TMF) is a standard filing system of essential study documents kept at the coordinating centre/site. A TMF will help with efficient study management and is needed to facilitate the reconstruction of the conduct of the study during the audit/inspection process.
For more information please read: http://www.ct-toolkit.ac.uk/routemap/trial-master-file
Quality Assurance, Auditing and Monitoring
Why will my trial be monitored and audited?
It is important that all clinical studies are appropriately monitored and audited in line with regulations and sponsor requirements. Monitoring and auditing allows us to ensure trials are being performed accurately and safely to ethical and legal requirements. In conducting monitoring and auditing processes we ensure that are patients are safe during trials and that their rights are being upheld, it also offers reassurance to trial teams that their trial is being conducted as planned and spots any issues which could hold back the progress of your project. The frequency of monitoring will depend on the risk of the study, but all trials will be audited annually regardless of their risk.
How will the PCTU decide how to monitor and audit my study?
All trials supported by the PCTU undergo a risk assessment. Our risk assessment takes into consideration a number of factors including the experience of the team, the type of patients being considered, any drugs or procedures being used in the trial, the trial design and the proposed data collection methods. Depending on the outcome of the risk assessment, we will agree on a Monitoring Plan for the study with the study team and sponsor.
The Monitoring Plan will outline the plan for study start-up and site initiation, level and frequency of monitoring for the study, detail all relevant contacts and outline the procedure for trial close out.
Data Management
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Statistics
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Health Economics
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Other
I am interested in working at the PCTU, do you have any job vacancies?
Job vacancies are advertised on our Current Vacancies pages. Check back here regularly for new job vacancies.
What short courses and events do PCTU run?
We runs some short courses and events throughout the year. Further information about our courses and events can be found on our Courses and Events home page. Link?
How can I find a trial to take part in?
The PCTU are not involved directly in recruiting patients to trials. However, the following links to databases allow you to search for trials in the UK and abroad.
Glossary of terms:
- BCC – Barts Cancer Centre
- CRF – Case Report Form
- DM – Data Management
- IG – Information Governance
- PCTU – Pragmatic Clinical Trials Unit
- Sponsor – for more information on the definition of sponsors please go to http://www.ct-toolkit.ac.uk/routemap/sponsorship/
If you have any questions that have not been answered in the FAQs, please email: pctu-enquiries@qmul.ac.uk
