Balancing research with responsibilities to patients can be a difficult task for doctors, nurses, allied health professionals and clinical academics.
The NIHR Clinical Research Network: Yorkshire and Humber supports researchers in different roles to deliver research.
One such role is that of Principal Investigator. A Principal Investigator, or PI, has overall responsibility for a trial at a particular site. From the initial expression of interest, right through to trial delivery and closure, a PI has oversight of all research components. The Medicines and Healthcare products Regulatory Agency (MHRA) states that while PIs do have oversight of their studies, it must also be documented correctly.
Following a recent evaluation exercise, Tracy Wood, Senior Research Sister at Calderdale and Huddersfield NHS Foundation Trust, was asked by the Clinical Research Network: Yorkshire and Humber to pilot a Principal Investigators’ Masterclass for the region, incorporating a key new element: a three-month feedback mechanism. This additional feedback was to capture the ‘real life’ impact of the course, rather than what attendees predict they will do when they complete the evaluation on the day.
“I’ve had a keen interest in PI oversight and, in this Trust, we introduced regular meetings with PIs to discuss their trials about four years ago,” explained Tracy. This enabled their meeting report and discussion to be documented and available as evidence that oversight took place, if and when inspected by the MHRA.
“Emily McDougal, Good Clinical Practice Programme Lead for the Network, asked me to look at how the masterclass was delivered nationally and how it could be implemented locally.
Tracy added: “Introducing the feedback mechanism at a local level has really helped researchers keep on top of their work.”
Tracy has delivered four PI Masterclasses over the past year using materials provided by the NIHR CRN National Coordinating Centre Learning and Development team. Feedback received from the sessions has shown that the workshops have added real value to the work of researchers.
One attendee said: “I am more vigilant and aware. I ask my research nurses more questions about study conduct and practice.”
Another added: “The masterclass allows for participant discussion around current practice and how improvements can be made. It was good to hear how colleagues elsewhere are approaching their responsibilities as PI.”
The PI Masterclass is a course delivered face-to-face and split into five modules:
- delivering quality through oversight;
- delegate, don’t abdicate;
- data;
- consent is more than saying ‘yes’;
- safety
Upon completion of the course, attendees are expected to have a comprehensive understanding of what it means to be a PI, and to be able to implement practical solutions to help improve practice where needed.
Emily McDougal said: “Tracy has taken a fantastic lead on this work and it is now at a stage where it can be rolled out across the wider Yorkshire and Humber region.
“The masterclass continues to exceed expectations and Tracy has been a large part of this. It is great that she has been able to focus on this work alongside her other responsibilities.”
Those wanting to find out more about the PI Masterclass, and other clinical practice courses offered by the Network, should visit: https://www.nihr.ac.uk/our-faculty/clinical-research-staff/learning-and-development/national-directory/good-clinical-practice/our-courses/