Where to Upload Documnets to Bhs Regarding Training

To continue to receive updates on combined review and other updates from the HRA you need to subscribe to HRA Now.

This folio contains information for those involved in the submission of applications for Clinical Trials of Investigational Medicinal Products (CTIMPs).

The combined review service provides CTIMP applicants and sponsors with a single application road and co-ordinated review, leading to a single Britain determination.

Every bit of 1 January 2022, combined review is the way all new CTIMP applications must be made. If y'all are a offset-time user, please contact united states of america at cwow@hra.nhs.uk for assistance to get started.

For all CTIMP applicants and sponsors, there are important differences in the service to empathise and actions yous can have to prepare for the changes. These are explained beneath, along with specific data for combined review applications involving ionising radiation and/or a medical device. Please explore our contents section and discover out more.

Please note: CTIMP applications via combined review must be submitted using a new part of the Integrated Inquiry Awarding Arrangement (IRAS).

The benefits of combined review

Combined review offers a single application submission and co-ordinated review leading to a single UK decision for Clinical Trials of Investigational Medicinal Products (CTIMPs). It was developed by the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA), working closely with the National Found 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 Clinical Trial Dominance and Enquiry Ethics Committee (REC) opinion
• a co-ordinated review process that ensures REC and MHRA outcomes are consequent and aligned
• a streamlined and efficient awarding process – a single submission; a co-ordinated review; combined communications to request farther information; and a unmarried communication to confirm the last decision - some users report a 30 per cent improvement in overall trial gear up times
• a single unified request for changes or clarifications from the MHRA and the REC
• REC opinion and MHRA authorisation delivered together
• the same streamlined awarding and review process for subsequent substantial amendments to the trial authorisation
• improved access to the NIHR Clinical Inquiry Network (CRN)'s Study Back up Service for researchers, with the opportunity to apply for support before and receive an eligibility conclusion sooner through the CRN'south new Non-commercial Portfolio Application service

What should sponsors and CROs exist doing to prepare?

Combined review must now be used for all new CTIMP and combined IMP/device trials. Sponsors and investigators are brash to familiarise themselves with the process. Equally applications are completed and submitted in a new office of IRAS, the following preparations 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 non appear on the list, send the full proper name of the system and the sponsor contact e-post address to service.desk@hra.nhs.uk so the details tin be added to the system
• ensure you are aware of the key guidance documents - links below
• contact united states for support with your kickoff combined review application at cwow@hra.nhs.u.k.

We recommend you lot complete the get-go three steps now. This volition help avert any delays and ensure y'all are ready to begin an application. You lot should besides consider whatever impacts on your internal processes and procedures.

What's dissimilar almost the new arrangement?

Submissions via combined review have some fundamental differences. They are:

• You must submit to the REC and the MHRA together; there is no provision to make separate submissions via this process. This may require organisations to work differently.
• You tin add collaborators to your project who will have editing permissions to work on the application, make the submission and work on any amendments and reporting requirements. Discover out more about the collaborator role in our featured video below.
• Individuals working on the application can view and revise the application information directly in the organization, and can also generate a PDF of a draft application to share with colleagues before it's submitted to the sponsor.
• Messages from the system, for example Requests for Further Data (RFIs) or a final outcome issued, but go to a specific prepare of contacts. Therefore if organisations have dissimilar teams working on dissimilar parts of the awarding, you must have effective internal communication mechanisms in place.
• Yous volition receive a consolidated initial outcome. If there is annihilation that needs to be addressed for the trial to be canonical, you should respond within 14 days. If you lot demand more than time to respond to an RFI, yous can formally request an extension. Electronic mail clintrialhelpline@mhra.gov.uk and let usa know how much time across the usual 14 days is needed. Applicants receive a final decision on their application within 10 days of receipt of a response to an RFI.

CTIMP studies involving ionising radiation

In time to come we desire these studies to be managed cease to end in the new system just for at present, if your trial proposes ionising radiation exposures you should proceed to utilise standard IRAS to complete the following elements of your application:

• Medical Physics Expert (MPE) and Clinical Radiation Practiced (CRE) review – Part B section 3 in the IRAS grade, for all studies involving exposure to ionising radiation
• ARSAC Preliminary Research Assessment (PRA) form, for studies involving exposure to radioactive materials.

The IRAS Grade should so be uploaded equally a PDF supporting document in new IRAS.

For full instructions on how to make your submission, delight see our IRAS Help. We also have a defended webinar for CTIMPs that involve radiation. You lot can admission this via the link in our Webinars section beneath.

At that place is no change in the process to submit an application to ARSAC.

Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials)

On 1 January 2022, combined review also became the way all new combined IMP/Device trial applications are made. If you are planning a new IMP/Device application, visit our IRAS Help for instructions on how to make your submission.

Featured video

We've produced a short explainer video about collaborators and other user roles in the system, including recent changes. Cheque it out below.

Webinars for CTIMP applicants, sponsors and NHS/HSC organisations

To support y'all with the combined review transition, we have been running a series of gratuitous webinars for user groups involved in CTIMPs. These provide an overview of new improvements and how the changes may touch you, depending on your role.

There are no live sessions currently scheduled, but you tin can find all our combined review webinar recordings via our online booking system. You will need to register for an business relationship on the Learning Direction System.

Research Ethics Committees (RECs)

All RECs authorised to review CTIMPs are able to review combined applications. This includes the Fast-track REC. Visit our REC directory to search meeting dates.

hintzebegovere.blogspot.com

Source: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/combined-ways-working-pilot/

Share this post