All CTIMPs, Medical Device Clinical Investigations 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. A proportion of all other clinical research undertaken locally is also monitored. Sponsor monitoring focuses on overseeing prevention or mitigation of 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 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.
Monitoring normally consist of an initiation monitoring visit, visit(s) during the active phase and a visit at close out.
During the monitoring visit 'findings' may be noted and graded as Observations (opportunities for improvement) or Non-conformances (against clinical trials regulations, protocol or SOP). Corrective and Preventive action (CAPA) will be agreed to 'fix' the problem and stop recurrence.
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.