Data Governance and Role Responsibility
- Below roles all should have some form of involvement in the Data Governance process. We will define a few of these roles and what their responsibility should be in the process.
Corporate and Line Level System / Process Level
• Senior management • Process / data owner
• Executive sponsor • System owner (IT mainly or process owner)
• Corporate data integrity committee • Data stewards
• [Site data integrity committee] • Technology stewards
• Line management • Users
• Quality assurance • Quality assurance
• Corporate IT
It’s their duty to set an overall objective for the data governance and data integrity programme. They should take leadership for the data governance programme, allocate the budget and resources for the Data Governance programme and management review of programme.
They are a member of senior management who participate in Data Governance Steering Committee meetings, liaison between Senior Management and Data Governance Steering Committee, promote best practices for Data Integrity and an open culture, approve the corporate Data Integrity policy and empowers and authorises the Steering Committee’s work.
Co-ordinates the overall Data Governance and Data Integrity programme across sites/divisions: defines the road map, priorities, etc., define criteria for assessment and remediation of systems: improved Data Integrity and business efficiency, establishing procedures for mapping and monitoring of data processes, prepares progress reports for management to review, approves and monitors Data Integrity projects within the programme, reviews business and compliance benefits of Data Integrity projects and reviews after completion to see benefits have been obtained, allocates resources and budgets to DI projects, implements and monitors Data Integrity training at all levels e.g. corporate Data Integrity policy, good documentation practice for paper, hybrid and electronic systems and define an open culture where mistakes are admitted so that that management has an understanding of risk in each process.
Interpretation of current regulations and regulatory guidance to feed into the Data Governance programme, compliance overview of the Data Governance programme, compliance review of projects and their deliverables, defines the Data Integrity requirements for quality and technical agreements with suppliers, Data Integrity audits: internal and supplier and Data Integrity Investigations.
Responsible for the business process (Annex 11).
No definition provided, Data governance should address data ownership throughout the lifecycle (MHRA & WHO) and accountability for data processes (WHO).
Responsible for the availability, and maintenance of a computerised system and for the security of the data residing on that system (Annex 11).
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