Quality management and protocol compliance

When managing a project, you must ensure the safety of your research participants and the integrity and quality of the study data. This is a necessary regulatory requirement (when you have the right approvals) because important conclusions and recommendations will come from this.

During the course of research projects, it is not uncommon for unforeseen issues to arise that could potentially affect the safety or more likely the integrity of the study data. If these do happen, study team members are encouraged to discuss these issues early on, usually as protocol deviations, so that corrective and preventative measures can be put in place to gain as much as possible from the research project.

If you are conducting a CTIMP study, and you think an issue might constitute a Serious Breach, please follow Royal Brompton and Harefield hospitals' SOPs.

Unforeseen issues that could affect patient safety or integrity of study data include:

  • protocol violations
  • research-related clinical incidents
  • issues that are not expected to occur in association with the procedures outlined in the research protocol and subject population being investigated.

This could result in, but is not limited to:

  • enrolment of ineligible subjects
  • incorrect intervention given
  • study assessments outside of the protocol window
  • consent issues
  • lapse in study approval (i.e. implementation of amendment without appropriate approvals in place)
  • under-reporting of safety information.

These unforeseen issues often occur because of multi-factorial reasons, and as a result of a number of influencing factors, often without the control of individual study team members. However, to learn from these situations, Royal Brompton and Harefield hospitals has to be aware of issues as they arise. It operates a ‘no blame’ culture of openness and honesty so that the focus of any incidents reported will be on improvement rather than consequence.

If you encounter unforeseen issues in a research study or are aware of protocol violations that may affect patient safety or the compromise study data, you are encouraged to report these to the PI immediately.

The PI (or delegated individual) should also contact the Research Office within 24 hours of becoming aware of any issues. The initial contact may be made in person or via email to safetyreporting@rbht.nhs.uk.