How clinical research sites handle compliance issues is perhaps the most critical aspect of their profession. Understanding and mitigating compliance risks not only ensure the highest level of patient safety and care, but are also necessary for all partnerships, funding and government oversight elements of a research business. With patient data security and safety concerns on the rise, it’s crucial for research organizations to monitor all facets of the clinical trial process closely to ensure that regulatory compliance is maintained. Using clinical trial software offers a one-two punch; the system empowers your organization to track many facets of compliance and offers robust reporting on compliance for funding or government auditors.
Protocol non-compliance is one of the FDA’s top clinical trial problems. This issue can affect patients’ health and rights as well as your sites’ revenue, credentials, and reputation. Non-compliance often happens not because of a large scale error, but rather because of smaller yet critical issues not being tracked and fixed in real time. To mitigate this problem, set up real-time alerts within each of your trials to track document expiration, version changes, drug disbursement, and procedure updates. A centralized CTMS helps the site team and management ensure protocol is being followed across each trial.
Using a CTMS can help track different areas of compliance throughout your research sites. Consider that the average research business user uses 27 pieces of software for one trial. Tracking anything across this many systems is challenging, but when it comes to compliance issues, it can be detrimental. Choosing a CTMS that’s agnostic to EMR or other internal systems can bring visualization of the systems into alignment, helping your team keep on top of compliance regulations.
You can also activate a CTMS to not only track patient and trial data, but also to manage research staff training and credentialing. Set up parameters for each type of training or credentialing required, and align all staff based on the renewal date or other relevant triggers. The system can then be programmed to automatically remind staff and management to upcoming deadlines, training opportunities, or revised credential guidelines.
Addressing the bottlenecks that most affect your organization’s compliance will improve your teams’ work and can help protect you from negative audits. To find out how to address other potential challenges in the areas of finance, project management or recruiting, use our interactive guide “Breaking Clinical Trial Bottlenecks.”