Quality should be intrinsic to the project, with the main objective of quality by design being to ensure patient safety and data integrity. Building quality into clinical research programmes is the responsibility of everyone involved and requires a continuous assessment of risk factors.
Project-specific risks can be managed by central monitoring, (also referred to as ‘in-house’ or ‘remote’ monitoring. They can also be managed by on-site monitoring; ‘on-site monitoring’ may be conducted remotely, or by using a mixed-model approach of remote and in-person visits. The purpose of monitoring clinical research is to verify that the:
- rights and wellbeing of participants are protected
- reported clinical research data are accurate, complete, and verifiable from source documents
- conduct of clinical research is in compliance with the current approved protocol/amendment(s), the principles of GCP, and the applicable regulatory requirement(s).
The approach to monitoring should be proportionate to the type and risk of the clinical research, as determined by the risk assessment. The specific details regarding the type of monitoring to be used may be documented in the protocol, or in a separate document that is typically referred to as a monitoring plan.
Details on monitoring including creating a monitoring plan and conducting central & on-site monitoring can be found in the UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB).
See also accordion titled 'Oversight committees (TMG, TSC, DMC)'.
An audit is systematic and independent examination of both project-specific activities and their related documentation. An audit is used to determine whether the activities that have been evaluated were carried out in accordance with the project’s protocol, local procedures and policies, and any other applicable regulatory requirements. An audit will also assess whether the clinical research data were appropriately recorded, analysed and accurately reported.
At the UoB, the CRCT manages and deliveries the UoB clinical research audit programme. The CRCT’s audit programme covers clinical research activity within the UoB including trial audits, audits of the UoB’s two CTUs, the two HTA-licensed tissue banks, GMP areas, laboratories, external vendors, and ‘for cause’ audits. See the UoB Clinical Research Quality Manual (UoB-CQM-POL-001) (Word - 558 KB) for more details.
Sponsor Support Visit (SSV)
At the UoB, the CRCT manages and deliveries a Sponsor Support Visit (SSV) programme that is design to be a facilitative visit to the investigator and research team. It involves discussing and reviewing your project, including key processes and documents such as the participant consent and enrolment, the collection and processing of data and tissue sample management, as applicable. The visit allows the CRCT to share best practice between teams, as well as providing suggestions where areas of work might need further attention to ensure full adherence to applicable regulations and standards. SSVs usually look at one research project at a time and focuses on one of the following themes: Good Clinical Practice (GCP), GCP in the Laboratory or Human Tissue across the whole project.
Currently both SSVs and audits are selected at random using a risk-based approach to identify potential clinical research projects. Expectations for conducting and reporting on audits and SSVs are captured in the UoB Compliance Review SOP (UoB-CPR-SOP-001) (Word - 96 KB).