This page contains information for participants who are involved in the submission of applications for Clinical Trials of Investigational Medicinal Products (CTIMPs).
We are pleased to confirm that the combined review service, formerly known as Combined Ways of Working (CWoW), will become the way that all new CTIMP applications are submitted from 1 January 2022. Combined review offers a single application route and co-ordinated review leading to a single UK decision for Clinical Trials of Investigational Medicinal Products (CTIMPs).
The service is open now to all CTIMP sponsors and applicants. If you have any new CTIMP applications planned over the coming months, these should be submitted via combined review wherever possible. If you’re a first time user, please contact our team at firstname.lastname@example.org who can provide help and support to get started.
Even if you do not have any applications coming up, there are still important differences in the service to be aware of and actions you should take to prepare for the changes. These are explained below, along with specific information for those involved in the submission of combined investigational medicinal product and medical device trials. Please visit our content sections to find out more.
Please note: CTIMP applications via combined review must be submitted using a new part of the Integrated Research Application System (IRAS) and should not be started in the standard part of IRAS.
The benefits of using our combined review
The combined review service offers you a single application submission and co-ordinated review leading to a single UK decision for Clinical Trials of Investigational Medicinal Products (CTIMPs). It’s been developed in partnership by the HRA and Medicines and Healthcare products Regulatory Agency (MHRA), working closely with colleagues from the National Institute for Health Research (NIHR), Clinical Research Networks and the devolved administrations.
Benefits for CTIMP sponsors, Contract Research Organisations (CROs) and investigators include:
- a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion
- a co-ordinated review process which ensures that REC and MHRA outcomes are consistent and aligned
- a streamlined and efficient application process – involving a single submission, a coordinated review, combined communications to request any further information required and a single communication to confirm the final decision - some users report it improved overall trial set up times by 30%
- a single unified request for changes or clarifications from the MHRA and the REC
- REC opinion and MHRA authorisation delivered together
- the same streamlined application and review process for any subsequent substantial amendments to the trial authorisation
- improved access for researchers to the NIHR Clinical Research Network (CRN)’s Study Support Service, with the opportunity to apply for support earlier and receive an eligibility decision sooner through the CRN’s new Non-commercial Portfolio Application service
What should sponsors and CROs be doing now to prepare?
Sponsors and investigators are encouraged to familiarise themselves with the new process and where possible, gain experience of using the new service early.
Where new CTIMP applications are planned in the coming months, these should be made via the combined review service. This means applicants only need to make one submission and will receive one co-ordinated review and outcome.
As applications are completed and submitted in a new part of IRAS, the following preparation activities are needed:
- register for an account in the new part of IRAS
- sponsor organisations are selected from existing options in IRAS. If your organisation does not appear on the list, the full name of the organisation and the sponsor contact e-mail address should be provided to email@example.com so that the details can be added to the system
- ensure that you are aware of the key guidance documents - links below
- identify upcoming trials to submit via the combined route
- contact us for support with your first combined review application at firstname.lastname@example.org
Whether or not you have a CTIMP application coming up in the near future, we recommend that you complete these first three steps now. This will help avoid any delays and ensure you are ready when you do need to begin an application. It is also important that you consider any impact on your internal processes and procedures.
What’s different about the new system?
Making a submission via the combined service has some key differences. These are:
- This is a single application process and therefore you must submit to both the REC and the MHRA together; there is no provision to make separate submissions via this process.
- You will be offered REC meetings which corresponds with the date of submission so you may not see your local or usual REC listed when you make your booking.
- Once the application is complete and has been booked to the REC meeting, the sponsor or their delegate will need to complete the final authorisation step promptly, before the REC meeting cut-off date.
- The system is designed so that individuals can view and revise the application information directly in the system rather than by generating a pdf of an in-progress application. This may require consideration of how things such as QC processes can be undertaken in the system instead of generating a pdf of the information. You can add other collaborators to the system with view-only or read-write access for this purpose.
- Communications from the system (for example where a request for further information is made or a final outcome issued) only go to a specific set of contacts. Therefore, where organisations have different teams working on different part of the application, you will need to ensure that you have effective internal communication mechanisms in place.
- You will receive a consolidated initial outcome and where there are issues which need to be addressed for the trial to be approved, you will be expected to provide a response to all issues within approximately 14 days. This improves the efficiency of the overall process, and is in line with the existing arrangements for MHRA.
Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials)
From 1 January 2022, the combined review service will also become the way that all IMP/Device trial applications are made. Further details and guidance about this will be provided shortly. For the time being, IMP/Device trial applications should continue to be created and completed using the standard part of IRAS.
If you have any queries, please contact us at email@example.com
Key guidance and documents
To get started, you should first ensure that you are familiar with the guidance below. If you have any further questions, please contact us at firstname.lastname@example.org .
Introduction to the combined review video
You can watch a presentation on Introducing our combined review and way of working on our Learning Management System platform.
To access the video, you will need to register for an account on the Learning Management System.
Participating Research Ethics Committees (RECs)
From 1 October 2021, all RECs authorised to review CTIMPs will be able to review combined applications. Visit our REC directory to search meeting dates.