The University must provide assurance that standard operating procedures (SOPs) are in place for all research groups operating across the University's HTA licence. SOPs are fundamental to ensuring that licensed activities are undertaken consistently, in accordance with regulatory requirements.
All people working under the licence are expected to work according to the procedures set out in the University core SOPs (where applicable) and HTA licence core SOPs.
Core SOPs should be used for all clinical trials sponsored by the University, and clinical research where appropriate, including research involving the collection and storage of relevant material. When more detail is required than appears in a relevant University core SOP, local SOPs and work instructions should be developed, provided they are compliant with University core SOPs. Generic template SOPs are provided for local adaptation in order that licensed activities are undertaken consistently.
Text highlighted in yellow within documents is advisory and should be deleted when documents are finalised. If there is a footnote with details of the original author and the copyright logo of the University of Oxford, please retain them.
Please refer to this page for the latest approved version of each document for HTA Licence 12217.
On 1 October 2018 the core documents and template documents for HTA Licence 12217 will be moved to a new quality management system called iPassport.