DATA SHARING POLICY

Experimental and Clinical Gastroenterology Journal follows the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, developed by the International Committee of Medical Journal Editors available at www.icmje.org.

ICMJE Recommendations ("The Uniform Requirements")

Data Sharing

The ICMJE’s data sharing statement policy is detailed in an editorial (see Updates and Editorials [www.icmje.org/update.html]).
As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.
Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial's registration. The ICMJE's policy regarding trial registration is explained above. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared (“undecided” is not an acceptable answer); what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism). Illustrative examples of data sharing statements that would meet these requirements are provided in the Table.

Table. Examples of Data Sharing Statements That Fulfill These ICMJE Requirements*

	Example 1	Example 2	Example 3	Example 4
Will individual participant data be available (including data dictionaries)?	Yes	Yes	Yes	No
What data in particular will be shared?	All of the individual participant data collected during the trial, after deidentification.	Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).	Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).	Not available
What other documents will be available?	Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code	Study Protocol, Statistical Analysis Plan, Analytic Code	Study Protocol	Not available
When will data be available (start and end dates)?	Immediately following publication. No end date.	Beginning 3 months and ending 5 years following article publication.	Beginning 9 months and ending 36 months following article publication.	Not applicable
With whom?	Anyone who wishes to access the data.	Researchers who provide a methodologically sound proposal.	Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.	Not applicable
For what types of analyses?	Any purpose.	To achieve aims in the approved proposal.	For individual participant data meta-analysis.	Not applicable
By what mechanism will data be made available?	Data are available indefinitely at (Link to be included).	Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).	Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University’s data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).	Not applicable

* These examples are meant to illustrate a range of, but not all, data sharing options.

Authors of secondary analyses using shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. They must also reference the source of the data using its unique, persistent identifier to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. As collaboration will not always be possible, practical, or desired, the efforts of those who generated the data must be recognized.
International Committee of Medical Journal Editors [http://www.icmje.org/about-icmje/faqs/icmje-recommendations/]. Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals [08/01/2019] Available from: http://www.ICMJE.org.