Staying Audit Ready: 3 Audit Trail Essentials for Research Compliance

Audits happen. It’s not a matter of if, but when. When an audit arrives, the institutions that come out stress-free are the ones that don’t have to scramble to pull records at the last minute because they’ve already moved to a proactive culture of compliance long before the audit started.

In this post, we’re going to walk through three key steps to help your institution become and stay audit-ready. But, first let’s look at why audits matter.

Research compliance gets more attention every year

Federal agencies are one of the largest sponsors of research at universities and health systems. However, federal funding also comes the expectation that institutions and organizations can demonstrate responsible use of the funds they were awarded.

Today’s regulations are more complex than in the past, and sponsors are checking in more often to ensure that regulations are being followed. Alongside these ever-evolving regulations, the way audits are conducted is also evolving. Instead of only reviewing paper documents, auditors now use advanced tools to examine full, digital transaction histories, looking for gaps, inconsistencies, and anomalies.

This increased scrutiny is driving more teams across the research field to modernize their systems, improve overall visibility, and make audit readiness a daily operational standard. 

With that in mind, let’s get into three key ways that you can help your institution become and stay audit-ready.

1: Identify vulnerabilities.

To keep your institution audit-ready, you must first know where you are most likely to fall short. In research compliance, a few high-risk areas trip up institutions time and time again:

• Protocol Submissions: A complete, on-time submission is your very first compliance checkpoint. Gaps in the records such as missing approvals, outdated versions, or submissions that happened after work began are some of the most common issues reviewers flag.
• COI Disclosures: Conflict of interest requirements exist at both the federal and institutional levels, and they don’t always align neatly. Administrators must ensure disclosures are collected on time, routed correctly, and thoroughly documented. 
• Effort Reporting: The basics of effort reporting such as frequency, process, and oversight are too often assumed rather than clearly communicated. Every administrator working on sponsored projects should understand the expectations, including exactly what triggers a correction and how that gets documented. 

Procurement, subrecipient monitoring, and cost management also come up frequently. You can read our blog, Six Factors for Better Compliance, for more tips on these areas.

2: Centralize documentation

When an audit happens, what auditors want most is documentation they can trace. Staying away from shadow systems, emails, or verbal explanations are ideal when submitting for an audit. That’s why it’s helpful to keep a clean database of original documents, attached to the right transactions, in a modernized platform that provides reporting and documentation. 

A connected, cloud-based research administration solution will let you attach documents directly to transactions, control who can initiate and approve actions, automate workflows, and pull records quickly when you need them. Institutions that have made the shift from manual processes to an integrated solution will consistently find it easier to respond to audits and have fewer errors overall.

Looking for more on what research compliance means in your day to day? Check out: What Is Research Compliance and Why Does It Matter?

3: Empower professional judgement

Compliance isn’t always black and white. Professional judgment is something you build over time, through training, working through tough calls with colleagues, and documenting your reasoning when the answer isn’t obvious. 

Attending sessions like webinars, conferences, and peer community events contributes to that track record and helps give you a strong knowledge foundation.

Because research administration doesn’t have a formal degree pathway yet, professional development is one of the best investments a team can make. 

Cayuse makes compliance easier

Staying audit ready takes the right combination of processes and tools. Cayuse Compliance Management is built to help research institutions manage IRB, IACUC, IBC, COI, and export control workflows with the documentation infrastructure and reporting that enables proactive compliance.

Learn more about Cayuse Compliance Management