All CTIMPs, medical device trials and other higher risk studies sponsored by the University of Aberdeen and / or NHS Grampian are monitored on behalf of the Sponsor(s) using a risk-based approach to monitoring. A proportion of all other clinical research undertaken by University of Aberdeen – NHS Grampian staff is also monitored. Sponsor monitoring focuses on overseeing prevention or mitigation of important and likely risks to data quality and to processes that are critical to participant protection and study integrity. Effective monitoring is necessary to ensure:
- The rights, wellbeing and safety of study participants are protected.
- Study data is secure, of high quality, accurate, complete and verifiable from source documents.
- The conduct of the Study trial is in compliance with the current approved protocol/amendments and is conducted by approved personnel.
- Research misconduct and fraud are deterred and inadequate research practices are identified before they escalate to research misconduct.
- GCP is promoted and compliance with guidelines for research governance, including applicable regulatory requirements, is achieved.
During the monitoring visit 'findings' may be noted. These may be graded as Observations (opportunities for improvement, or areas where a potential non-conformance may occur if no improvements are made) or Non-conformances (a non-conformance against UK clinical trials regulations, Sponsor SOP or technical (study specific) SOP). Non-conformances should state the documentation against which non-conformance has been identified. Non-conformances may be graded as 'serious' or 'non-serious' as appropriate. Serious non-conformances are reviewed by the Clinical Studies Oversight Group (CSOG).
Corrective and Preventive action (CAPA) should be agreed with the monitor to 'fix' the problem and stop recurrence in the future. These should be addressed within a pre agreed timescale and when completed, to the satisfaction of the monitor, the finding may be closed.
A proportion of hosted studies shall be monitored in a similar way.
Commercial studies shall be monitored by commercial research monitors on a frequency dictated by the commercial sponsor.
CTIMPs, medical device trials and other higher risk studies
For higher risk studies, once a sponsor risk assessment has been conducted a monitoring plan will be created by the QA team based on that risk. Should there be any significant changes during the lifetime of the study, the risk assessment may be adapted to meet these changes and a revised monitoring plan created.
The risks which are considered include the following:
- Single or multi centred.
- The type of study (e.g. CTIMP, Surgical, Device etc).
- Involvement of third parties (including their QA provisions).
- Participants (e.g. children, vulnerable persons, pregnant etc).
- The research team's/site experience with clinical trials.
- Licensed or unlicensed use of a licensed medicinal product.
Monitoring shall normally consist of an initiation monitoring visit, visit(s) during the active phase and a visit at close out.
Each of these monitoring visits shall be organised in discussion with the research team and shall be conducted by Research Monitors employed by the sponsor. The Research Monitors shall review essential documents and source data and shall require members of the research team to be available to answer questions and queries.