Contractual or project initiation document clinical safety obligations

The clinical safety officer needs to be suitably trained and qualified in risk management or have an understanding in principles of risk and safety as applied to health IT systems. A clinical safety officer needs to have completed appropriate training. Whilst suitable training is provided by NHS Digital in partnership with other bodies it is recognised that there are other methods to acquire relevant skills, such as masters modules in Patient Safety. It would be beneficial for a clinical safety officer to have experience of conducting clinical risk management activities in an appropriate clinical setting.

Please refer to sections 2.2 – 2.6 of the DCB0129 specification to ascertain the high-level obligations by which the supplier and the health organisation will adhere. At this stage both parties in signing the contract are in agreement with the above and have carried out all necessary due diligence regarding the referred to information.

The extent of clinical risk analysis and hence the level of resources required to support the process will need to be commensurate with the scale, complexity and level of clinical risk associated with the release.

The assessment of the required resources may be guided by experience from previous developments, including input from personnel involved in those developments. The level of resource required would also be dependent on the health IT system development timescales.

The nominated resources need to have sufficient time available to allow them to apply a suitable level of effort to ensure the clinical risk management process is completed in a robust and competent manner. Such personnel will be able to contribute their specialist knowledge to ensure the clinical risk management activities are executed as competently and completely as possible.