Transparency requirements for clinical trials/human interventional studies

All health and social care research involving an intervention in human participants (definition available here) is subject to additional transparency requirements.

The 3 key obligations for researchers (as set out in the University’s Good Research & Innovation Practices policy - see right-hand link) are:

  • Recording of study details in advance of the research commencing, in a publicly accessible registry (unless a valid reason for deferral exists, e.g. commercial sensitivity, in which case the study should be registered as soon as this reason no longer exists);
  • Reporting of (at least summary) results (including on the registry where the study was originally registered) in a timely fashion following the end of the trial. This should ideally be within 12 months, unless there is a valid reason for a delay such as timeframes for publication processes, or restrictions imposed by commercial funders;
  • Making the findings (whether positive or negative), and wherever possible, the data, from clinical trials and human interventional studies accessible with adequate consent and privacy safeguards, in a timely manner after they have finished, in compliance with any applicable regulatory standards.

The purpose of these obligations is to ensure that a complete and accurate record of all clinical trials/human interventional studies are available as part of the research record for use by other researchers, clinicians and service providers in order improve health and social care.

The University expects all researchers involved in clinical trials and health and social care human interventional studies to meet these obligations, in addition to complying with any specific contractual or regulatory requirements that apply to their research.

Where can I register my study?

The following public registers of clinical trials are available; some apply only to certain types of study. NB. Members of the International Committee of Medical Journal Editors (ICMJE) will only consider a clinical trial for publication only if it has been registered in an ICMJE-approved registry – these include EudraCT and ISRCTN.

EudraCT

EU Clinical Trials Database (EudraCT):

This is the official register for clinical trials of investigative medicinal products (CTIMPs) or medical devices, in accordance with EU regulation; these studies must also be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA). NB. This registry is not suitable for the registration of other types of human interventional study. No fee is charged for registering a trial, but fees will apply for applying for authorisation from the MHRA. Further details can be found on the MHRA website:
- CTIMPs
- Medical devices

ISRCTN

ISRCTN registry:

This is a primary clinical trial registry recognised by WHO and ICMJE. It accepts any study designed to assess the efficacy of health interventions in a human population (including both observational and interventional trials). A fee is charged to cover the cost of maintaining a public registry that is free to access. All MRC-funded studies must be registered with ISRCTN and the MRC will normally agree to cover the registration fee if this is included in the grant application.

ClinicalTrials.gov

ClinicalTrials.gov:

This registry is provided by the US National Institutes for Health but is available globally. It allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:

  • Any applicable human subject or ethics review regulations (or equivalent)
  • Any applicable regulations of the national or regional health authority (or equivalent)

No fee is charged. This is the best option for the registration of student projects.

Details of how to register your study can be found here. The University of Sheffield has an institutional account with the site's registration system (a ‘PRS’ account), which is 'USheffield'. The account administrator is Lindsay Unwin (l.v.unwin@sheffield.ac.uk), who will be able to provide login details.

*Other registries may be applicable in certain circumstances (e.g. in collaborative projects involving organisations based in other countries)
Further guidance on transparency requirements for health and social care research can be found on the Health Research Authority’s website