GQ6-Governance and quality system standards

 a)   There are documented risk assessments for all practices and processes requiring compliance with the HT Act and the HTA’s Codes of Practice.

• Investigators should complete a risk assessment from procurement to disposal and send this to JRES and the Designated Individual DI. pmadhou@citystgeorges.ac.uk

 b)  Risk assessments are reviewed regularly.

• Risk assessments should be reviewed periodically (typically, every 1-3 years) and the actions to mitigate risks updated as necessary.

• Risk assessments should also be reviewed following an incident.

• Processes in place to ensure participant’s wishes are checked before forwarding their material, and notification given to receiving organisation of their wishes if required.

• The audit trail contains details of consent and location of signed consent form, full details of where samples were received from and sent to.

•  A Material transfer Agreement is in place when material is being transferred to or received from other organisations.

• Risk assessment of transportation method should include verification of maintenance of cold conditions where necessary by use of data loggers, with data retained on file.

 c)  Staff can access risk assessments and are made aware of risks during training.