Data sharing statement
Once the unblinding of data no longer compromises the integrity of the platform and/or other domains, a de-identified data set collected for the analysis of domains within PLATIPUS will be made available.
The following conditions must be met before data can be shared:
All domains in which the participant is co-enrolled are closed to recruitment*
Primary domain conclusions/analyses have been published, AND
The two-year follow-up of participants within the domain/s of interest is/are complete.
This is estimated to be approximately six months following the completion of the two year follow-up of domain participants.
*Where one or more domains where a participant is co-enrolled are not yet closed to recruitment, the participant’s data may be provided without the treatment code to prevent unblinding in unfinished domains.
Supporting materials will also be available, including the Core Protocol and Domain-Specific Appendices, Data Dictionaries, and the Domain-Specific Statistical Analysis Plan. Data may be requested from the University of Melbourne by emailing info@platipustrial.org. Data access requests will be subject to the PLATIPUS sub-committee (including the Lived Experience and Indigenous Health Committees) review and may include communication between parties before approval. The Pregnancy Domains OR Neonatal Domains Committee will undertake the initial review, followed by the Trial Management Committee, Lived Experience Committee and Indigenous Health Committee.
The Statistical Advisory Committee may also be asked to review the request before forwarding it to the PLATIPUS Trial Steering Committee for approval. The PLATIPUS Trial Steering Committee will approve/disapprove the data request. Data will not be released until a Data Transfer Agreement and Authorship Agreement has been signed by relevant parties and evidence of ethical approval for the requested purpose has been received. The provision of data may incur a fee.
Once finalised, a copy of the PLATIPUS Data Access and Sharing Policy and associated documentation will be added to the website.
