Skip to Main Content

Research Data Management (Health Sciences)

Tips for managing data and creating a data management/sharing plan.

Why include a data sharing plan with my trial registration?

In addition to it being useful to develop a sharing plan early in your research process (it can help guide some of your data management processes), the International Committee of Medical Journal Editors (ICMJE) released a statement in 2017 saying that anyone hoping to be published in one of their member journals must include a data sharing plan in their ClinicalTrials.gov registration.

What should my data sharing plan include?

ICMJE included a helpful table that details recommendations for what to include in the data sharing plan. Here are the questions you should aim to answer with your data sharing plan:

  • Will individual participant data be available (including data dictionaries)?
  • What data in particular will be shared?
  • What other documents will be available?
  • When will data be available (start and end dates)?
  • With whom?
  • For what types of analyses?
  • By what mechanism will data be made available?

Open the PDF below to view the table which includes some examples.

ClinicalTrials.gov Form