PHRP follows the data sharing policy described in “Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors”
(https://doi.org/10.3346/jkms.2017.32.7.1051). As of July 1, 2018 manuscripts submitted to ICMJE journals that report the results of interventional clinical trials must contain a data sharing statement as described below. Clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trial's registration. The ICMJE's policy regarding trial registration is explained at https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. 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. All of the authors of research articles that deal with interventional clinical trials must submit data sharing plan of example 1 to 4 in Table 1. Based on the degree of sharing plan, authors should deposit their data after deidentification and report the DOI of the data and the registered site.
Table 1. Examples of data sharing statements that fulfill these ICMJE requirements*
|Element||Example 1||Example 2||Example 3||Example 4|
|Will individual participant data be available (including data dictionaries)?||Yes||Yes||Yes||Yes|
|What data in particular will be shared?||All 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 at 3 months and ending at 5 years following the article publication.||Beginning at 9 months and ending at 36 months following the 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.||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.||Not applicable|
|Data are available for 5 years at a third-party website (link to be included).||Information regarding submitting proposals and accessing data may be found at (link to be provided).|
ICMJE = International Committee of Medical Journal Editors.
*These examples are meant to illustrate a range of, but not all, data sharing options.