Data Sharing Statement Policy for Clinical Trials Enacted July 2018

The International Committee of Medical Journal Editors (ICMJE) is a working group of medical journal editors that makes recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Journals that state they follow the ICMJE recommendations include: Academic Medicine, American Journal of Epidemiology, Cancer Nursing, Chest, Circulation, Immunology & Cell Biology, Journal of Dental Hygiene, and Radiology. 

These recommendations cover a range of topics, including:

  • defining the roles of authors
  • conflicts of interest
  • corrections, retractions, republications and version control, and copyrights
  • advertising
  • clinical trials

As of July 1, 2018, manuscripts submitted to ICMJE journals reporting on the results of clinical trials must include a data sharing statement. Data sharing statements must indicate the following:

  • if individual de-identified participant data will be shared;
  • details of the data that will be shared (inclusion of data dictionaries, study protocol, statistical analysis plan, etc.);
  • when the data will become available and for how long; and
  • by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).

Examples of such statements are available on the ICMJE Website. As noted by Pitt’s Research Conduct and Compliance Office:

“If you have provided information in the Individual Participant Data (IPD) Sharing Statement module of your study record, you should ensure that this information matches the data sharing statement submitted with the manuscript. Questions should be directed to the journal to which you are submitting.”

Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial’s registration.

Members of HSLS Data Services are available for consult when writing your data sharing statement.

~Melissa Ratajeski