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Oxford University Hospitals NHS Foundation Trust
Research and Development

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Registering a study

The Health Research Authority is now implementing its plans for ensuring that UK trials are registered in a publicly accessible database.

The HRA has a commitment to promote transparency in research, and has worked in consultation to develop plans to implement a set of practical and proportionate measures to improve transparency of research in the UK and to improve patient and public confidence in health research. It is now implementing the proposal to make trial registration a condition of the favourable ethical opinion.

Requirements

From 30 September 2013 registration of clinical trials in a publicly accessible database will be a condition of the favourable ethical opinion. Failure to register will therefore be a breach of good research practice and managed through standard operating procedures for Research Ethics Committees (RECs) in line with other breaches.

The studies for which registration is mandated will initially be determined by the IRAS filter question. It will include the first four categories on the Integrated Research Application System (IRAS) filter question number 2, namely:

  • clinical trial of an investigational medicinal product
  • clinical investigation or other study of a medical device
  • combined trial of an investigational medicinal product and an investigational medical device
  • other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.

The current IRAS question A50-1 will continue to apply to all other studies, where plans for registration are asked for and the plans considered by the REC. For these four categories, the requirement will become mandatory and not, therefore, reviewed by the REC.

Implementation

The HRA expects all studies to be registered before the first patient is recruited, the sponsor and investigator will be in breach of the favourable ethical opinion if the study is not registered:

Within six weeks of the first patient recruitment or, for medical device studies within the timeline determined by the current registration and publication decision trees.

The HRA will consult with the devices industry with an intention of bringing the requirements for devices studies in line with other clinical trials by March 2014.

Documentation and reporting

The REC opinion letter will be updated from 30 September 2013 to state that for studies falling into the categories above that registration is a mandatory condition of the favourable ethical opinion in line with this guidance. Sponsors and investigators are not required to make a separate notification to the REC confirming the trial has been registered, but they should do so at the earliest opportunity – for example, if submitting an amendment or progress report. The HRA will be putting in place simple mechanisms to audit compliance and will publish registration rates.

Previously approved studies

The HRA expects current and previous studies to be registered and results to be put in the public domain.

Next steps

The HRA recognises that other studies should be registered but that further consideration is required given the range of studies reviewed in the UK and the HRA needs to determine who should make the judgement for other studies. This will be considered alongside other HRA initiatives including the Ethics Officer pilot and HRA assessment and approval business case development.

The HRA is putting in place plans to update the applicant and sponsor declaration on new studies, to declare that previous studies have been registered and published. The HRA expects to update the declaration in early 2014 as a further mechanism to ensure research transparency.

EudraCT Number

EudraCT is the European Clinical Trials Database of all clinical trials. Registration is compulsory for every clinical trial with at least one site in the European Community, and provides a unique identification number for the trial, the EudraCT Number.

The CI should register the study online at:

Protocol registration

Journals that follow the Guidelines released by the International Committee of Medical Journal Editors (ICMJE) require many studies to have been listed on an independent, free to access, validated, public register.

It is also a requirement of the Declaration of Helsinki that all studies are registered

This includes:

  • trials whose primary purpose is to affect clinical practice
  • trials providing evidence of clinical effectiveness or adverse effects
  • investigations of the biology of disease
  • collection of preliminary data that may lead to larger clinical trials
  • device trials.

The trial must be registered before the first patient is recruited.

Acceptable registries include:

clinicaltrials.gov for which the OUH has an account
Please contact the OUH R&D Department if you would like an individual user account created for you to enter your trials.

International Standard Randomised Controlled Trial Number Register (ISRCTN)
There may be a charge for registration. Some funding bodies require ISRCTN registration. For NIHR portfolio adopted studies access to this system is free of charge. Please contact the Lead Comprehensive Local Research Network (LCLRN) for further information.