HPA reviewed ACI’s clinical databases with the aim of developing a policy and guidelines for managing these databases into the future.
HPA interviewed program managers, data managers and executive, developed a survey and collected data on the databases, and reviewed documents in relation to the databases (e.g. quality guidelines, data dictionaries, regular reports).
HPA reported the findings of the review and developed a policy and accompanying guidelines for the ACI to manage its clinical databases. The policy and guidelines outlined the regulatory context for the creation of data collections by the ACI, articulated principles for creating and managing data, and specified governance processes for approval of different types of data collections. They also outlined processes for other data management issues, such as changes to data collections, periodic reviews, data security, data linkage, disclosure of data held by the ACI, and ACIs management of data obtained from other organisations.