Research Data Management (Health Sciences)

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.

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation
to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.

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.

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation
to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.

Clicking on this link will initiate making a copy of the template. Fill it out with your plan, then use it to complete your IPD Plan during registration or share with whomever is helping you register your trial.