• The very first thing you must do is create a protocol

Before you make applications to the regulatory bodies, you must create a protocol.

A protocol is a full description of intended activities; from setting up to archiving and publishing. It serves as a manual for the research team and is used to monitor your study’s progress.

Your protocol should be complete and should be peer reviewed BEFORE you apply for sponsorship.

As the potential sponsor, we cannot write your protocol for you. We can review the finished, peer-reviewed protocol for legal compliance.

This is because the sponsor is the last department to review the protocol and permits it to be submitted through IRAS. We are not trained medical writers, trained statisticians, or medical doctors. As such, we cannot write or review these aspects of your protocol. We also use this document to risk assess your trial, and so need the document to be complete and peer reviewed to be able to do this.

Before coming to us, an independent suitably qualified specialist in the field must review the protocol for its medical accuracy and safety. A statistician must be recruited to establish the correct sample size, and the appropriate statistical analyses for the types of data your study will generate.

You can write the protocol yourself. Alternatively, some CIs employ a commercial medical writing company for a fee. It is up to you to decide this, and it is your responsibility to pay any medical writing company used.

The HRA have devised a protocol template. This template contains all the potentially relevant sections for a research protocol, and advice on what details should be in each section. When reviewing your protocol for legal compliance, this HRA template is the standard we use.

The University will review this document and carry out a risk assessment before it can agree to sponsor a trial.

As part of the UoM sponsorship process, you will require faculty approval.

These approvals are proof that the proposed research has undergone an appropriate level of peer-review, that the Chief Investigator has the relevant experience and expertise to undertake the proposed research, and that there is, or will be sufficient funding in place to see the project through to completion.

The sponsorship team will ask for this when you apply for sponsorship e.g. access to PURE.

All clinical trials require a sponsor. A sponsor takes legal responsibility for trials and provides insurance. The University acts as a sponsor for all clinical trials conducted by its own staff and does this through our team. The university can be the sponsor even if it is not the funder.

Where your research will be conducted at one of the University’s MAHSC partner NHS Trusts, the Trust contact should be approached regarding sponsorship. Where your research is to be conducted outside of the University’s partner Trusts it may be necessary to approach the University of Manchester for sole or co-sponsorship. 

Where the University is not acting as Sponsor for a study it needs to retain a record of clinical trials for which their staff are acting as Chief Investigator. Please complete this form and email it to clinicaltrials@manchester.ac.uk. 

To learn more about the sponsorship process please contact the team clinicaltrials@manchester.ac.uk.

You must apply for funding to pay for your trial. This will likely be done in tandem with applying for sponsorship to save time. Funding covers running costs, which includes things like:

• Salaries for trial staff including (but not limited to) statisticians, health economists, qualitative researchers, the trial team
• Production, testing, labelling, packaging, distribution, and destruction of trial drugs or medical devices
• Blinding services
• Randomisation services
• Laboratory usage and equipment purchases (e.g.: centrifuges, freezers, monitors, etc.)
• Computing: hardware, software, computer consumables
• Web design costs
• Printing and postage costs: protocols, consent forms, data forms, questionnaires, posters and newsletters, questionnaires, Freepost licence (for participants to return questionnaires)
• Consumables (stationery, office furniture, filing cabinets, photocopying)
• Statistical services
• Database design/data collection system, development, or purchase
• GCP monitoring and audit
• CTA (MHRA) application fee
• Amendment fees
• Code-breaking services
• Participant expenses and incentives (subject to funder approval)
• Public involvement: travel expenses, out-of-pocket expenses, and payment for involvement
• Telephone/fax/email to maintain regular contact with sites and participants
• Advertising costs
• Site costs (telephones, internet, photocopying, fax, data collection, nursing support staff and other site staff)
• Travel for site visits for initiation, training, monitoring and close-out meetings, researcher costs
• ‘Flagging’ of participant records if required for long-term trial follow-up with Health and Social
• Care Information Centre (www.hscic.gov.uk).
• Meetings: trial management, steering and monitoring groups and other meetings
• Publication and dissemination: protocol publication costs, mail shots to participants (including postage costs), journal publication fees which may include Open Access fees and attendance at conferences
• Archiving costs
• Sponsorship costs

A funding application will need to be done separately to the sponsorship application. You will approach funders yourself; we do not direct you to funders or make applications on your behalf. However, we can advise on what types of costs your trial may incur, which can help you make your application. We also estimate sponsorship costs for you. The sponsor needs to be kept informed of the funding application, even when UoM is not the funder.

Costs must be agreed with the proposed sponsor and relevant NHS R&D office. To ensure that the costings for the proposed research are an accurate reflection of the true costs, please contact your School Research Support Business Manager, for further assistance.

The Medicines and Healthcare Products Regulation Agency (MHRA) gives Clinical Trial Authorisation (CTA). You need this authorisation to be able to legally use experimental products on patients or use existing treatments in an experimental way.

When you apply, reviewers at the MHRA will determine the following:
- Is it legal?
- Is it reasonably safe (based on available evidence)?
- Is there a plan for detecting potential problems and a plan for protecting participants against those problems where possible?
- Can the clinical and statistical methods produce trustworthy results?
- Are investigators committed to making their results public, irrespective of the trial outcome?
- Are participants the most important consideration?

The MHRA, HRA, and NHS REC no longer require separate applications (one for the MHRA, one for both the HRA and NHS-REC).
Instead, one combined application is submitted for approval by all three institutes. This is done through the Integrated Research Application System (IRAS).

An application to the MHRA, HRA, and NHS REC is done through the Integrated Research Application System (IRAS). There is a standard application fee, and there will be fees for any amendments made until the end of the trial.

As the sponsor, we can provide you with guidance on how to fill out IRAS forms. We will review your application for legal compliance and compare your IRAS form to your protocol to ensure the information being given is consistent.

Email clinicaltrials@manchester.ac.uk for advice about your IRAS application. Alternatively, below are links to the IRAS system, and the three institutes.

IRAS link

MHRA link

You need approval from the Health Research Authority (HRA) to be able to work with NHS patients, data, staff, and facilities.

The HRA oversees all research conducted through the NHS because it has a duty of care to participants either as patients/service users or NHS staff/volunteers, including the use of their data or tissue. This also includes use of NHS facilities.

The HRA uses the ethics assessment to determine if you are permitted to use NHS patients, data, staff, and facilities.

The MHRA, HRA, and NHS REC no longer require separate applications (one for the MHRA, one for both the HRA and NHS-REC).
Instead, one combined application is submitted for approval by all three institutes. This is done through the Integrated Research Application System (IRAS).

An application to the MHRA, HRA, and NHS REC is done through the Integrated Research Application System (IRAS). There is a standard application fee, and there will be fees for any amendments made until the end of the trial.

As the sponsor, we can provide you with guidance on how to fill out IRAS forms. We will review your application for legal compliance and compare your IRAS form to your protocol to ensure the information being given is consistent.

Email clinicaltrials@manchester.ac.uk for advice about your IRAS application. Alternatively, below are links to the IRAS system, and the three institutes.

IRAS link

HRA link

The research ethics committee (REC) is a group of up to 15 people who will receive your application and have a formal meeting to discuss and assess it. A third of the group will be “laypeople” who are not professionally involved in research or healthcare. The REC is entirely independent of the sponsor, the funder, and the research team.

The REC will determine whether the proposed benefits of your research outweigh the potential risks, and whether you have ensured that individual participant safety is always more important than the outcome of the trial.

The MHRA, HRA, and NHS REC no longer require separate applications (one for the MHRA, one for both the HRA and NHS-REC).
Instead, one combined application is submitted for approval by all three institutes. This is done through the Integrated Research Application System (IRAS).

An application to the MHRA, HRA, and NHS REC is done through the Integrated Research Application System (IRAS). There is a standard application fee, and there will be fees for any amendments made until the end of the trial.

As the sponsor, we can provide you with guidance on how to fill out IRAS forms. We will review your application for legal compliance and compare your IRAS form to your protocol to ensure the information being given is consistent.

Email clinicaltrials@manchester.ac.uk for advice about your IRAS application. Alternatively, below are links to the IRAS system, and the three institutes.

IRAS link

NHS REC link

Once you have obtained sponsorship, funding, and submitted your application through IRAS, you will receive an email from IRAS to let you know whether the MHRA, HRA, and REC considers your trial valid (i.e.: whether you have submitted all the requested documents, and whether the trial is within their remit to review). Once you have this confirmation, the MHRA and REC have 60 days to return a response to you.

Once you have uploaded your application documents, you must book a REC meeting. This sets a date and time for the REC group to discuss your trial.

The review response can be either to:

• Approve your trial outright
• Approve your trial on the condition that certain additional criteria are met
• Confirm that your trial will not be approved

A conditional approval subject to additional criteria means you will be sent a list of corrections. You will make changes to your protocol in order to satisfy the committee that the trial is ethical, safe, and effective. According to the MHRA, more than half of the application they receive result in a conditional approval, and that the issues identified are often common and avoidable. Please read this information from the MHRA detailing common mistakes that you can avoid and improve the chances of your trial being accepted without further changes.

If you receive a notification that your trial has not been approved, you have 14 days at the point of notification to appeal this decision.

You are permitted to withdraw your application at any point after you have submitted to IRAS. The one exception to this is that you cannot withdraw your application after grounds for non-acceptance have been issued.

If your trial is still rejected after your appeal, you would have to redesign your trial and resubmit as a new trial (with the corresponding fee and new ID numbers).

Once your trial has been approved, the sponsor will commence the Greenlight process, which gives permission from UoM to start your trial. Please see the sponsorship process for more information on this.

The MRC and Department of Health have developed a process map on how to plan a new trial. The route map can be viewed on the Clinical Trials Tool Kit site.

Where the University is not acting as Sponsor for a study it needs to retain a record of CTIMPs for which their staffs are acting as Chief Investigator. The following form should be completed and emailed to the Research Governance, Ethics and Integrity Manager of Clinical Trials.

If the University is being requested or may be requested to act as sponsor or co-sponsor for a CTIMP please follow the SOP entitled ‘Processing requests for confirmation of sponsorship for funding applications for Clinical Trials of an Investigational Medicinal Product or Device’

The Medicines and Healthcare products Regulatory Authority (MHRA) expects the University to be aware of all CTIMPs which are being led by its employees whether or not the University is acting as sponsor of the study. This is particularly important if any of the funding for the trial is coming via the University.

This registration should be completed if all of the following apply: 

• The chief investigator or other lead investigator of the CTIMP is an employee of the University of Manchester
• Full sponsorship of the trial is being undertaken by an organisation(s) other than the University 
• The study falls under the Research Governance Framework, 2nd edition (2005), and The Medicines for Human Use (Clinical Trials) Regulations 2004

University of Manchester employees whose only involvement in a CTIMP is to recruit, treat or follow patients according to a standard protocol (for example a commercial trial or an investigator led trial) need not register that study.

Each CTIMP need only be registered once by the most senior University of Manchester investigator using the registration form.