Audit and Investigation into incidents and complaints

An audit is:

"A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)"
ICH GCP Guidelines 1.6 (1996)

As part of the Department of Health’s Research Management and Governance requirements, formal audits of research activities/projects taking place within the NHS must be undertaken. The Department of Health’s minimum standards for research governance state that at least 10% of projects should be routinely audited. This is in addition to the routine monitoring reports that are required as a condition of NHS Permission.

A programme of formal audits of projects being hosted by primary care in Norfolk & Suffolk is being rolled out by the R&D office at NHS Norfolk, however audits may also be conducted by the Sponsor, or other party involved in the management of a piece of research (e.g. CRO)

We have produced the attached draft flyer to give some guidance on what to expect from a research audit conducted by the PCT. This may also be of use if you are being audited by an external organisation.

Inspections

Clinical Trials on medicinal products (i.e. those that fall under the EU Clinical Trial Directive) may also be subject to inspection by the MHRA.

Investigation of incidents and complaints

Any incidents and complaints from participants, staff or researchers must be reported through normal PCT incident or complaints systems. These will usually be fully investigated by the R&D office and any points of learning incorporated into guidance and information for researchers and staff.

For further information please contact the R&D office at NHS Norfolk.