Welsh Government

Do I need to register the study?

Your study must be registered on a publically available database, and this is handled through the UK’s online Integrated Research Application System (IRAS) when a researcher applies for permissions and ethical approval. Find out more about IRAS here.

Researchers are expected to ensure transparency when conducting research so that findings and best practice are shared for the benefit of the public. Transparency also ensures that research is not duplicated or unnecessary.

Research should be registered on a publicly accessible database. There are a number of different registers according to the type of research and for some types, for example clinical trials of investigational medicinal products, this is required by EU law and also by the ethics committee prior to ethical review.

A researcher may also need to register the study on a national research register or portfolio in order to access NHS support such as research delivery staff. Find out more here.

Registering a research study is required to ensure transparency. In the UK study registration is coordinated within IRAS, streamlining the process. When a study is registered it receives a reference number for that database.

Examples of this include the mandatory reference number for clinical trials of medicinal products, allocated by the European Medicines Agency and is called the EudraCT number. There is also a register for randomised controlled trials and studies are allocated an International Standard Randomised Controlled Trial Number (ISRCTN) when registered.

What is the Health and Social Care Portfolio?

The Health and Social Care Portfolio is a register of high quality health and social care research studies active in Wales. Registering on the portfolio gives you access to NHS support for study delivery like research nursing.

Each UK country manages its own research portfolio and researchers need to register their study in the country where they plan to conduct the research. Commercial and non-commercial research studies can be registered on the portfolio. Each study has to meet specific criteria to be eligible for the research portfolio in all UK countries.

Eligibility criteria can be found here.

Researchers are required to provide regular reports of numbers of participants recruited to the study. This is a straightforward process and support is available to researchers to help them report activity, contact the portfolio team here.

It is important to register the study on the Health and Social Care Portfolio in order to access study delivery support within the NHS. The national research portfolio in each UK country also provides research activity data to inform how funding is allocated across the research infrastructure in the UK. The review of study eligibility to be on the portfolio is conducted when the researcher applies for permissions to conduct the research through the online Integrated Research Application System (IRAS).

Researchers are required to provide regular reports of numbers of participants recruited to the study. This is a straightforward process and support is available to researchers to help them put reporting in place.

For more information contact your local NHS R&D Office.

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