Combined review webinars for applicants, sponsors and NHS/HSC host organisations
Combined review comes into effect for all Clinical Trials of Investigational Medicinal Products (CTIMPs) from 1 January 2022. Combined review is where a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion is made. There is a combined communication to request any further information and a single communication to confirm the final decision.
This service was initially run as a pilot that started in 2018 under the name ‘Combined Ways of Working (CWoW)’ before being rolled out wider. From January 2022 it will be the only way to submit CTIMPs to MHRA and REC. Applications are completed and submitted in a new part of IRAS.
To support this change, we’re running a series of free, live webinars during December and January. They are designed for different user groups involved in CTIMPs and will provide an overview of upcoming changes and how they may impact you, depending on your role.
There are three webinars available:
- Combined Review as an Applicant – aimed at those completing combined review applications in new IRAS
- Combined Review for Sponsors - aimed at those fulfilling the role of a sponsor (or sponsor delegate) for CTIMPs
- Combined Review for NHS/HSC Participating Organisations – this is for those working in NHS, HSC and R&D organisations who deliver CTIMPs, helping staff understand the documentation they will receive through the process.
The aim of the webinars is to:
- provide an introduction to upcoming changes to aid your understanding
- enable you to check the impact of the changes on your own organisation outside of the webinar, and update any internal processes/procedures as required
- guide you to available resources providing further information and support.
The webinars will be recorded and a version will be made available for anyone who cannot attend a live session. Please note: these webinars will not be a step by step demonstration of how to work in the combined review system or a formal training on new IRAS.
How to book:
Please log onto the HRA Learning Management System (LMS) to view dates and book your place. It is free to register.
If you would find it helpful to attend more than one of the webinars, you are welcome to do so.