Review of strategic and operational issues for registries

Agency for Clinical Innovation, 2012

The ACI engaged Health Policy Analysis to undertake a project to review existing ACI clinical databases with the aim of developing a policy and guidelines for the Agency’s management of these databases into the future.

Health Policy Analysis interviewed program managers, data managers and the ACI executive, developed and collected data on the databases through a survey, and reviewed relevant documentation in relation to the databases (e.g. quality guidelines, data dictionaries, regular reports) as well as more widely.

The outputs of the project were a report of the findings of the review, as well as a policy and accompanying guidelines for the management of clinical databases by the ACI. The policy and guidelines document outlines the regulatory context for the creation of data collections by the ACI, articulates principles for creating and managing data within the ACI, specifies a data governance process for approval of different types of data collections, outlines the policy for other data management issues such as changes to data collections, the requirement for periodic reviews, maintaining data security, data linkage, disclosure of data held by the ACI, and management of data by the ACI obtained from other organisations.