QMS - four new SOPs

New Standard Operating Procedures (SOPs) for Clinical Research 

The following four SOPs are effective as of 20-Jul-2020: 

QMS Development and Management (Word - 117 KB) 

The SOP describes for clinical research where a Quality Management System (QMS) is to be developed at the UoB, how this is to be developed and managed, including how QMS documents are prepared, reviewed with stakeholder consultation, authorised and implemented.

Healthy Volunteers and Medical Oversight (Word - 65 KB)

This SOP describes the procedures for the recruitment, management and medical oversight of healthy volunteers in clinical research. 

Skeletal Muscle Biopsies (Word - 66 KB)

This SOP describes the procedures for the oversight and conduct of skeletal muscle biopsies (not intended for diagnostic purposes) in participant, and provide further instructions and template with regards to evidencing compliance to these procedures. Associated QCDs: 

Food and Nutritional Components (Word - 66 KB)

This SOP describes the procedures for sourcing, storage, preparation and administration of food and/or nutritional components to participants. It includes repackaging and labelling of any bulk supplies, and the disposal of excess product. Associated QCDs:

See the Quality Management System (QMS) for further details and access to the full UoB QMS for Clinical Research.