Governance

While it is challenging enough building high-quality standards content, that is only half the battle. Once created the content needs to be managed, it needs to be governed, to make sure that it retains those qualities. When changes are requested the process needs to:

• Provide a timely response to requests for new or modified content
• Provide a process this is lean and not seen as an inhibitor to the work of the business
• A process that should aim to standardise as much as possible but not inhibit the science

The Governance Process

Assero will assess the needs of the organization taking into account its maturity in managing metadata and will determine if, when and how the various elements of the generic model should be best implemented within the organization. Essentially, governance will involve:

• A standards committee to guide the standards work across the organization and resolve any contentious issues
• A standards implementation team to undertake the day-to-day work required to build and maintain the organization’s implementation of industry standards.
• A therapeutic area specific view, tailoring standards for use within a therapeutic area
• For an individual study – the use of the standard as part of a given study. This also includes recording what was used.