|
We’ve made changes to IRAS for combined review thanks to your feedback.
You told us that you need to download study information that you’ve added to the system, to share it with colleagues before it’s submitted to the sponsor. The latest update means that you can save PDFs of draft applications.
We’re giving you more control of amendments because you told us that the automated system was confusing. Now, after you have used the amendment tool, you can use IRAS to control where the amendment goes. We’re not changing amendment types or what goes to each regulator but are giving you more clarity about your study. Don’t forget that anyone can create an amendment, but only the person who created it can work on it. All amendment related documents are visible in the project dashboard to anyone who has access to the study.
If you want to submit Developmental Safety Update Reports (DSURs) or Urgent Safety Measures (USMs) for more than one trial at the same time, we have blocked the ability to download them or associated requests for information, to protect confidential information from other users with access to the project.
And last week we told you about a change to automatic registration of clinical trials. The latest update means you can use IRAS to confirm that you will be registering with ClinicalTrials.gov and do not require automatic registration with ISRCTN registry.
Tell us what you think
We’ve also made some changes to IRAS to make it easier for you to tell us what you think. You’ll see a link in the system to a feedback form for comments, which can be made anonymously if you wish. The link is part of our beta banner, added to services which are still being tested and improved.
We’ve also added our accessibility statement which provides information and advice for people using the system and assistive technology. You’ll find it linked from every page.
A change to our plans for studies involving ionising radiation
We’re listening to feedback from applicants using new IRAS for combined review and are working with IRAS partners to review it and to plan for the future. To make sure that our review is a success we now need to pause some work that we had planned. This includes the ionising radiation module and ARSAC form which were due for release this spring.
If you’re applying for a CTIMP that involves ionising radiation, you will need to move between new IRAS and the old system to submit your application. This workaround is temporary and does not reflect the user experience we want you to have in IRAS. We have support available including guidance, a webinar and a helpful service desk.
The HRA is committed to delivering a world class regulatory system for all studies on behalf of the IRAS partners, and the pause will help us to do that.
As always, you can find the latest guidance on using IRAS for combined review on the HRA website.
|
