Quality Assurance (QA) is an essential element of any research and demonstrates a commitment by management and researchers to ensure the reliability of results and data generated, and provide confidence in the research undertaken.
Standard Operating Procedures (SOPs) are an essential source for communicating to researchers the agreed, defined methodology which must be followed to ensure consistency between researchers and, in multi-centre studies, the consistency between individual research sites.
SOPs may be complemented by other documents (including User Guides, templates, worksheets, training files etc). Along with a Quality Statement from senior management and a Quality Manual (which defines how an organisation shall implement and achieve any requirements) these are considered a Quality Management System.
A Quality Management System Matrix has been created; indicating the SOPs (in addition to the Quality Manual and Quality Statement) which the Sponsor requires particular researchers to be familiar with before commencing research. This document may be used to record the SOPs which have been read, including their version number, and be retained in the researcher's training record.
All QA documentation must be controlled to ensure that they are current, written and authorised by technically competent personnel, regularly reviewed and fit for purpose. QA documentation must also be available at the point of use for researchers involved in a study.
Various international standards and regulations exist and compliance with these may be required to demonstrate commitment to QA and oversight by management and Sponsor. Such compliance with international standards and regulations may be checked by regulatory compliance bodies; which may authorise continuing research by way of regulatory inspections or audit.
Sponsors of research are also required to conduct internal audits and regular monitoring inspections of research. These audits and monitoring activities are conducted by specially trained personnel appointed by the Sponsor. The frequency of such audits and monitoring activities shall be based on risk, determined by the Research Governance Manager and Quality Assurance Manager.
The Quality Assurance team for University of Aberdeen and NHS Grampian is based in the Research & Development Office in Foresterhill House Annexe.
The Quality Assurance team consists of:
Richard Cowie Quality Assurance Manager 01224 554656 email@example.com
Marlena Pirie Quality Assurance Support Officer 01224 554362 firstname.lastname@example.org
Lynn MacKay Research Monitor 01224 558003 email@example.com
Caroline Campbell Research Monitor 01224 558003 firstname.lastname@example.org