e-Pathway: Project Management

Quality & Oversight

Monitoring and/or audit activities

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).

Reporting requirements

In line with HRA guidance on progress reports and the UoB Project Set-Up SOP (UoB-SET-SOP-001) (Word - 346 KB), for the majority of projects an Annual Progress Report (APR) should be submitted to the REC which issued a favourable opinion of the project each year within 30 days of the anniversary of the date on which the REC favourable opinion was issued.  Report templates and further guidance are available via the Research Governance templates page

When submitting the APR, the Research Governance Team should be copied in using the researchgovernance@contacts.bham.ac.uk address. 

In line with government guidance on safety reporting, projects which have received MHRA approval should also submit a Development Safety Update Report (DSUR) to the MHRA each year on the anniversary of the date on which MHRA approval was issued. Support regarding the preparation of DSURs will be provided by the CTUs, and project teams should follow the relevant internal CTU processes. 

As with APRs, when submitting the DSUR, the Research Governance Team should be copied in using the researchgovernance@contacts.bham.ac.uk address. 

For portfolio adopted projects, the NIHR hold a record of the project on the Central Portfolio Management System (CPMS). It is essential that this information is kept up to date, especially in relation to changes to the end date and recruitment figures.  

See also Adverse Events & Deviations section of this e-Pathway.

Interim analyses

The statistical analysis plan (SAP) is used to document the pre-specified statistical methodology Interim analysis reports. The statistician will perform interim analyses as specified in the SAP.

Please refer to the UoB Statistics SOP (UoB-STA-SOP-001) (Word - 137 KB) for further information. 

Oversight committees (TMG, TSC and DMC)

The need for, and type of, project-specific oversight committees that are required depend on the type, size, complexity and duration of the research project and its associated risks. Listed below are the three main types of project oversight committees used in clinical research. Please note that there may be specific funder requirement to the setup of these committee.  

  • Project management group (also referred to as trial management group (TMG)); responsible for the day-to-day management of the clinical research. The purpose of the group is to ensure the clinical research is designed, conducted and reported in accordance with applicable internal and external regulations and standards (including relevant SOPs).
  • Project steering committee (also referred as trial steering committee (TSC)); provides independent oversight of the clinical research. Project steering committees are usually appointed for randomised trials. It can provide independent advice to the investigators on all aspects of the clinical research (e.g. recruitment, competing projects, CRF return, deviations etc.).
  • Data monitoring committee (DMC); provides an independent assessment of the safety, scientific validity and integrity of the clinical research.  

Please refer to the UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB) for further information. This SOP describes the process for identifying any project-related risks, and summaries the monitoring methods and management activities available to help mitigate risks.


Accessible version in the last accordion titled 'e-Pathway index'.  

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e-Pathway index

The clinical research e-Pathway provides a roadmap to the various stages and sub-stages that a researcher may follow during the lifetime of their research project. Click on a link to take yourself to the stage that is of interest, or you can use the roadmap image on each page to navigate through the process.  

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