Data sharing in clinical trials - practical guidance on anonymising trial datasets.

ABSTRACT: BACKGROUND:There is an increasing demand by non-commercial funders that trialists should provide access to trial data once the primary analysis is completed. This has to take into account concerns about identifying individual trial participants, and the legal and regulatory requirements. METHODS:Using the good practice guideline laid out by the work funded by the Medical Research Council Hubs for Trials Methodology Research (MRC HTMR), we anonymised a dataset from a recently completed trial. Using this example, we present practical guidance on how to anonymise a dataset, and describe rules that could be used on other trial datasets. We describe how these might differ if the trial was to be made freely available to all, or if the data could only be accessed with specific permission and data

SUBMITTER: Keerie C 

PROVIDER: S-EPMC5763739 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature