All Swansea University sponsored studies will be subject to a number of quality management activities. These include quality assurance, audits and support visits; document management; training; record retention and reporting; personnel roles and responsibilities; corrective and preventative actions. Activities are coordinated and conducted by the Research Quality Assurance Officer with the assistance of the Research Governance Manager and key members of the Sponsorship Oversight Committee.
Quality assurance (QA) is the process of planned and systematic actions that are established to ensure that the study is performed and the data is generated, documented (recorded), and reported in compliance with GCP. Quality Assurance is the sum of all the activities that contribute to the quality of a study. It includes checks, quality control, support visits and audit.
There is a hierarchy of quality assessment:
1. Self-check
2. Formal documented Quality Control (QC)
3. Independent audit
QA Activities conducted by the Research QA Officer:
• Review of all study documents during study set up
• Review of protocol, GCP non-compliance and serious breach reports, including follow up to ensure actions completed
• Conduct on-site support visits using a risk-based approach
• Review of study amendment applications and associated documentation
• Assist with study closure notifications and submission of final reports to regulators
• Review of annual progress reports
• Review of safety reports
Self-Check and Quality Control
Quality Control (QC) is an activity that involves the review of factors in a process as the process is occurring. This may be a self-check of one’s own work or it may be performed by a member of staff who is familiar with the procedures but has not personally undertaken the work. All QC checks should be documented and the documented evidence of QC should be retained. QC checks are applied to critical stages of data collection and handling to ensure that data is reliable and has been processed correctly. QC checks will be performed according to the risk level of a study with risk levels as stated in the SU Research Governance Quality Policy.
Sponsor Support Visits are a QC activity which involve an in-person visit by the resarch governance team. During the visit, the team will perform checks on all aspects of a study to oversee the progress of a study and ensure that it is being conducted, recorded and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirements. The visits are conducted according to the risk level of a study.
Independent Audit
The SU Research Governance team has responsibility for assessing risk at a regulatory compliance level but is not responsible for assessing all risks (e.g. financial, commercial, intellectual property) across every process. This responsibility falls under the remit of SU central governance and is outside the scope of this document.
Risk Management
Quality Risk Management is an essential part of an effective quality system. Risk management is the systematic process of identifying, analysing and responding to risk. It involves maximising the probability and consequences of positive events and minimising the probability and consequences of negative events. Risk management principles are applied to effectively target resources to activities that present a greater risk to data integrity, participant safety and /or reputation. Controls are defined in procedures to prevent errors, identify potential problems, and intervene before the problems become serious.
There is a risk assessment form which must be completed for all SU sponsored studies during the application process and the current version is available here and studies are categorised into 3 risk areas – low, medium, high – with associated monitoring activities. Please refer to the SU Research Governance Quality Policy for more information.
QA activities during the life cycle of a study
The following graphic shows the QA activities which will be undertaken on all SU sponsored studies, from when a study opens to recruitment, to when the final report has been submitted and the study is being archived.
Please note that QA activities are also conducted during study set up, and this graphic can be found here.