Abstract
BackgroundA large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme.MethodsThe relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored.ResultsA scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described.ConclusionsThe metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1686-5) contains supplementary material, which is available to authorized users.
Highlights
A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies
The scheme we propose is summarised by Table 1. It is based on the existing DataCite scheme for characterising data objects. (The reasons for this choice are given in the Discussion section below.) The portion of the table labelled B–E consists of intrinsic metadata that can be mapped to the DataCite scheme, whereas sections A and F represent proposed extensions to that scheme
That interrelationship is summarised in Additional file 2, whilst Additional file 3 shows how the mandatory and recommended fields in DataCite are treated within this proposal
Summary
A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). Recent years have seen a welcome push towards greater transparency in clinical research. As Vickers has recently described [6], there is an increasing consensus that a third element is required for full transparency – the source data itself, the individual. True transparency requires the availability of a wide range of clinical trial ‘data objects’, to use the generic term for anything available in an electronic format. These include published documents, documents that traditionally are private and seen only by the trial team, data sets representing summaries of results, and data sets representing the full source data. The assumption is not that all of these documents should necessarily be Canham and Ohmann Trials (2016) 17:557 made public, but that, subject to proper governance and the protection of individual participant privacy, they should be made available to bona fide researchers who can provide good reasons for requesting access
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