Table 1 Classification system for DSS (version 1)

Examples:

 1) “Centers will receive your center-specific evaluation via the publication and via the study groups.”

 2) “(As of June 2020): All researchers in this study”

 3) “Personal reasons”

 4) “The study is under reviewed by medical journal reviewer.”

N

No sharing

DSS states or implies that there will be no sharing of IPD. Different specific reasons may be provided.

Examples:

 1) “(As of April 2022): We will not plan to share IPD”,

 2) “The quantitative dataset will be provided by the service organisation in Leeds and they do not want this data to be made publicly available as it has some commercial sensitivity for them. … … IPD: Not expected to be available”,

 3) “Transfer of data to third parties excluded”,

 4) “Protect Patient's right EC's policy.”

0

No plans

DSS states that there are currently no plans regarding IPD sharing, or a decision has not yet been made

Examples:

 1) “(As of September 2021): To be determined”,

 2) “(As of December 2021): It is not yet clear, if the data will be shared or not.”,

 3) “Need a consensus from colleagues”,

 4) “(As of March 2022): There is no default plan to share individual participant data. May be considered upon reaching the VCU IRB”

V

Vaguely positive

DSS states or more normally implies that there will be some degree of IPD sharing, but no details are given or sharing appears limited.

Examples:

 1) “IPD sharing statement: The current data-sharing plans for this study are unknown and will be available at a later date. IPD: To be made available at a later date”,

 2) “(As of July 2020): demographic data of the participants and diagnostic test results will be shared”,

 3) “(As of February 2021): Anonymized and pseudonymized data will be published in peer reviewed journals and may be presented at congresses and conferences”,

 4) “(As of January 2022): The investigators will be sharing the data, but the management plan is being designed. Information available: Study Protocol”

R

By request

DSS implies that IPD can be obtained by request, though who to may not be explicitly stated. If stated it is usually the investigator, sometimes the sponsor.

Examples:

 1) “(As of December 2021): Upon request, deidentified participant data collected during the study may be shared. … ... Data will be made available upon request beginning 3 months following publication of the final article from this study, with no end date. … … Data requestors will need to sign a data access agreement.”,

 2) “What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published… …. Where to obtain: Data can be accessible through an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month… ….”,

 3) “(As of August 2021): Individual data collected during the trial will be available after deidentification upon request to the PI. … …Access Criteria: Deidentified data will be shared with any researcher requesting access. … …”

 4) “(As of October 2021): Upon reasonable request, IPD may be shared if fully compliant with HREC requirements and European GRDP regulations”

C

Complex

DSS states or implies that IPD will be available but under a more complex regime than any of those described above.

Examples:

 1) “De-identified IPD that underlies the results will be shared after publication of primary results and made available indefinitely to investigators whose proposed research have received ethical approval following execution of a data use agreement”,

 2) “What will be shared: All data is shareable. When: Access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: It is permissible to use this data to find patients who respond better to this treatment. Where to obtain: Contact … … . How to obtain: The request will be answered in a week in consultation with other partners in the project. … …”,

 3) “What data will be shared? Outcome data that underlie the results reported in the article (text, tables, figures and appendices) … When will data be available (start and end dates)? Beginning 12 months following analysis and article publication No end date Available to whom? Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept The University of Melbourne’s conditions for access Available for what types of analyses? Unspecified By what mechanism will data be made available? Written request to principal investigator at … …”,

 4) “What will be shared: All related data will be provided upon completion of the study after disidenti?ed (sic) IPD When: The related data will be inde?nitely (sic) provided upon completion of the study. To whom: Relevant information will be provided to all interested parties for humanitarian study and research purposes upon completion of the study. Conditions: On the condition that if any of the study methods (including study design and implementation method, measurement methods, etc.) are used the copyright law be observed and our study be cited. Where to obtain: This will be provided upon completion of the study. Contact: … How to obtain: Contact via email … ”

S

Via Storage

DSS states that IPD will be transferred to a repository – may be general, specific or institutional. More often not named specifically.

Examples:

 1) “(As of September 2020): The results of this study will be published as open access article and all IPD that underlie results in a publication will be shared, preferentially as supplementary data set or available in a public repository. Any sensitive personal data/information will be not included.”,

 2) “General dissemination plan: Planned publication in a high-impact peer-reviewed journal. IPD: Stored in non-publicly available repository”,

 3) “(As of February 2022): The fully anonymised datasets analysed during the study will be stored on a publicly available repository. The COG-UK HOCI study to be shared on the UCL Data Repository data-sharing platform so that the data may be reused by other researchers. … …Time frame: This will be done with 6 months of public reporting of results, with data available for 5 years. Access Criteria: Fully open access”,

 4) “(As of June 2021): The anonymized database will be uploaded into a public repository. Time frame: The database will be available upon publication of the results. Access Criteria: The data will be available in a public repository …”