By Beverly Ginsburg-Cooper, Senior Director, Huron Consulting Group
The term “compliance” can often carry a negative connotation at a research institution. It can be associated with bureaucracy, unnecessary paperwork, interfering with saving lives, and more. This is a challenge when trying to communicate the importance of compliance and establish a culture throughout an organization. To overcome this, it’s imperative to highlight how beneficial compliance is to research by protecting subjects and the institution.
So what type of approach can achieve this? When working to create a more adherent organization, there are two approaches that are generally taken:
1) After the fact: This approach includes audits, corrective actions, and suspension.
2) Prevention: Thoughtful, well-executed strategies and systems that assure appropriate conduct from the start of the trial.
Many institutions may use an “after the fact” approach, but it is not ideal for a few reasons:
- May not change behavior unless the penalty is high
- Builds resentment and anger
- Can be costly
- Doesn’t change the organization’s clinical trials culture
A preventive approach is more effective for the following reasons:
- 483s are embarrassing and costly
- Poor audits may mean a sponsor will stop working with a PI
- Low quality data submitted late may result in termination from a cooperative group
- Under-reporting adverse events may cause serious complications or death
While a preventive compliance strategy is ideal, it does require a change in thinking from catching problems to preventing them. It’s important to build compliance values and requirements into the day-to-day clinical trials life. This can be achieved through streamlining operations, adding services, and building staffing performance, among other ways.