Download PDFPDF

Sharing and reuse of individual participant data from clinical trials: principles and recommendations
Compose Response

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g.
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests


  • A rapid response is a moderated but not peer reviewed online response to a published article in a BMJ journal; it will not receive a DOI and will not be indexed unless it is also republished as a Letter, Correspondence or as other content. Find out more about rapid responses.
  • We intend to post all responses which are approved by the Editor, within 14 days (BMJ Journals) or 24 hours (The BMJ), however timeframes cannot be guaranteed. Responses must comply with our requirements and should contribute substantially to the topic, but it is at our absolute discretion whether we publish a response, and we reserve the right to edit or remove responses before and after publication and also republish some or all in other BMJ publications, including third party local editions in other countries and languages
  • Our requirements are stated in our rapid response terms and conditions and must be read. These include ensuring that: i) you do not include any illustrative content including tables and graphs, ii) you do not include any information that includes specifics about any patients,iii) you do not include any original data, unless it has already been published in a peer reviewed journal and you have included a reference, iv) your response is lawful, not defamatory, original and accurate, v) you declare any competing interests, vi) you understand that your name and other personal details set out in our rapid response terms and conditions will be published with any responses we publish and vii) you understand that once a response is published, we may continue to publish your response and/or edit or remove it in the future.
  • By submitting this rapid response you are agreeing to our terms and conditions for rapid responses and understand that your personal data will be processed in accordance with those terms and our privacy notice.
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

Other responses

  • Published on:
    Follow-up paper to the data sharing initiative, intended as a first step towards a generic but practical framework
    • Christian Ohmann, Consultant European Clinical Research Infrastructure Network (ECRIN)

    In the original publication a consensus document on providing access to individual participant data (IPD) from clinical trials was developed, using a broad interdisciplinary approach within the H2020 funded project CORBEL. The taskforce reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. What was still missing was a generic framework or architecture for data sharing that could be used for modelling, describing, and designing operations, data requirements, IT-systems and technological solutions. As a first step in developing an inventory of existing tools/services, and examining their quality and applicability for data sharing, a systematic analysis of processes and actors involved in data sharing was performed, based on the consensus document and summarized in a follow-up paper (1). The work done resulted in a systematic and comprehensive list of the processes and subprocesses that need to be supported to make data sharing a reality in the future. It is foundational work against which existing tools/services can be mapped, and gaps, where new tools/services are needed, can be identified. This follow-up work will facilitate the extension of the ideas in the original paper to create a generic but practical framework for the sharing of IPD from clinical trials. That framework is currently under development.


    1. Ohmann C, Canham S, Banzi R e...

    Show More
    Conflict of Interest:
    None declared.