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Operational clinical safety process - Dean Mawson

Contractual or project initiation document clinical safety obligations


This section describes the contractual and project initiation document (PID) content relating to clinical safety and the requirements regarding agreement and sign off for the benefit of clinical safety management.

Clinical safety officer appointment by health organisation

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.

Compliance with DCB0160 complementing the suppliers compliance with DCB0129

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 supplier and the health organisation agreement on resourcing the clinical safety activities for the project in line with DCB0129/DCB0160

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.

Last edited: 20 November 2018 3:37 pm