Quality Assurance Documents
Guidelines and Tools developed by the Quality Assurance Theme Group.
You can download the quality assurance documents below and modify them to suit your individual CRF requirements. When adapting for local use please ensure that the authors are acknowledged and that you check with your Quality Assurance Manager where appropriate.
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As a back-up, you can access the following PDF documents by following the corresponding link:
Internal Audit Toolkit
To support CRFs in developing an internal audit function, the UKCRF Network QA Theme Group has developed a set of audit tools and templates covering such aspects as risk assessment, creating an audit schedule, planning, conducting and reporting audits, tracking associated corrective and preventative actions (CAPA) and trend analysis of audit findings. These tools are designed to be adaptable, and CRFs are encouraged to adapt and localise them according to their own individual requirements. However, it is requested that the contribution of the UKCRF Network QA Theme Group is acknowledged.