Developing a topic-based repository of clinical trial individual patient data: experiences and lessons learned from a pilot project

Table 1 Data sharing platform comparison table

	CRIB	Vivli	UK data service	CSDR
Type of data access¹	Safeguarded	Open, safeguarded, controlled	Open, safeguarded, controlled	Safeguarded
Functionality for controlled analyses within a secure platform	No	Yes	Yes	For pharmaceutical trials: Yes For non-commercial trials: No²
Formal assessment of disclosure risk before depositing data	No	No - Anonymisation services offered for a fee	Yes	Yes (advice on de-identification)
Trusted repository status (i.e. international standard ISO 16363)	No	Unclear	Yes	CSDR is not a repository; they signpost users to data owners
International standard for meta-data (e.g. DDI)	Not achieved	Yes	Yes	Unclear
International standard digital object identifier (DOI)	Not achieved	Yes	Yes	Yes
Who is the legal entity	University of Liverpool	Vivli	University of Essex	Agreement between data owner and data user
Who manages approvals	Cochrane pregnancy and childbirth	Data owner or Wellcome	UKDS	Data owner or Wellcome
Researcher training	No	No	Yes	No

¹Open data, can be downloaded freely by anyone; Safeguarded data, downloadable but require an approvals process and legal agreements to structure data use (such as a licence agreement); Controlled data, pose disclosure risk to the organisation and can only be accessed by approved data users within a secured research environment (no download option and data use takes place in a secured setting)
²MRC, Cancer Research UK, Bill and Melinda Gates are piloting deposit of trial data with CSDR. Wellcome provide support and managed the independent review panel

ISSN: 2046-4053