Eliminate Audit Fatigue With Streamlined Protocol Management and a Clear Audit Trail

Protocol management is a cornerstone of successful research, ensuring studies meet regulatory standards, protect ethical integrity, and avoid costly compliance failures. However, despite using multiple protocol management tools, research teams at academic institutions and research organizations still face significant challenges.

A 2018 study by the FDP Faculty Workload Survey found that PIs spend 44.3% of their research time on administrative protocol management tasks rather than active research. This process not only delays research progress but also introduces risks such as audit fatigue, human errors, and missed deadlines.

In traditional protocol management systems, issues are often discovered too late, and teams remain reactive. Research teams typically rely on periodic checks, audits, and manual reconciliations across disconnected systems. This fragmented approach leads to wasted time, increased risks, and delayed research outcomes.

But what if there were a more efficient way to manage protocols? What if research teams could ensure protocols remain compliant, with every change properly logged, and proactively address any gaps as soon as they arise?

This is where eProtocol comes into play. Our protocol management platform moves teams from reactive, manual processes to a proactive system that ensures protocols are continuously maintained with accurate documentation, helping teams reduce inefficiencies, minimize risks, and streamline research progress.

How Key Solutions’ eProtocol Transforms Protocol Management

Here's how eProtocol helps overcome protocol management challenges:

1. Centralized Protocol Tracking

Rather than scrambling to collect data during audits, the eProtocol platform ensures that all protocol amendments are logged correctly throughout the research process. From submission through review and approval of IRB, IACUC, IBC or other protocols, every submission, amendment, and approval is tracked at every phase, ensuring everything is up-to-date and properly recorded.

Benefit: Research teams are always audit-ready, with information that’s accurately documented and accessible at any point.

2. Comprehensive Protocol Audit Trail

Every protocol update, approval, amendment, modification, and review is automatically logged in a centralized, timestamped audit trail. This creates a complete, transparent record of all protocol activities, from initial submission through final approval and ongoing modifications, ensuring accountability and making audit preparation effortless.

Benefit: When auditors request protocol documentation, you have a complete, chronological record of all protocol activities ready to present, eliminating the scramble to piece together information from multiple disconnected systems.

3. Elimination of Audit Fatigue

Research institutions face audits from multiple oversight bodies, including federal agencies (OHRP, FDA, USDA, NIH), accrediting organizations (AAALAC, AAHRPP), internal compliance offices, and study sponsors, each with its own standards, documentation requests, and timelines. 

The same protocol may be audited multiple times by different entities. Traditional systems make audit preparation exhausting, requiring staff to manually pull protocol records, verify training certifications, validate protocol amendments, compile consent forms, and assemble documentation for each audit request.

With Key Solutions eProtocol platform, institutions can ensure that protocol information is continuously maintained and logged as changes happen. When any oversight body requests protocol documentation, everything is already organized and audit-ready.

Benefit: Principal Investigators can minimize the effort involved in audit preparation and execution, reduce time spent on administrative tasks, and focus on advancing their research, knowing their compliance documentation is organized and accessible.

4.Improved Efficiency and Reduced Errors

Manual protocol tracking is time-consuming and prone to mistakes. A missed protocol approval or overlooked protocol amendment can cause delays and costly revisions. With Key Solutions eProtocol platform, protocol status is verified before the next phase begins, minimizing errors and reducing the risk of delays.

Benefit: Fewer protocol-related errors, fewer delays, and a more streamlined research process save time and resources.

Hypothetical Scenario 

To understand this better, let us walk you through a hypothetical scenario involving Dr. Alan, a Principal Investigator (PI) at a research institution. While this example is fictional, it reflects real-world issues faced by many researchers today.

Understanding the Case

Dr. Alan's team uses multiple software systems for multiple processes. 

• Finance software for aligning financial records with project goals
• IACUC software for animal research compliance and ethical protocol approvals
• IBC software for managing biosafety compliance

The Challenges

While Dr. Alan’s team was using various tools, they faced several key challenges, including:

• Manual Reconciliation: Dr. Alan’s team had to manually reconcile personnel lists and training requirements across IACUC and IBC systems to ensure researchers had proper authorization and certifications for both animal handling and biosafety protocols. This manual verification across disconnected platforms was time-consuming, error-prone, and delayed research progress when team members needed to be added or updated.
• Audit Fatigue: The team struggled with audit fatigue due to uncoordinated, overlapping checks and audits. Gathering protocol data from multiple systems, reviewing protocol status across IACUC animal protocols and IBC biosafety protocols, and ensuring everything aligned was repetitive and inefficient. This process risked overlooking key protocol details.
• Delays and Errors: The team often encountered delays due to the reactive nature of their tools. For example, if a required IACUC or IBC protocol approval was delayed, the team could not move forward with the research, causing wasted time and last-minute protocol corrections.

Shifting to an Effective Protocol Management System 

To tackle these challenges, Dr. Alan’s team adopted eProtocol, a protocol management platform. Transitioning from a reactive, manual system to a proactive, systematic approach reduced the administrative burden and minimized errors.

• Centralized Protocol Tracking: Instead of manually reconciling protocol data across systems, eProtocol tracked all protocols in real-time. Each protocol amendment was logged, and protocol revisions were tracked automatically, ensuring every change was documented throughout the protocol lifecycle.
• Accurate Protocol Documentation: The platform logged every protocol update and approval, creating a comprehensive audit trail that ensures transparency and accountability. Dr. Alan's team could rely on an up-to-date record of all protocol activities, without having to manually gather and verify protocol data.
• Reduced Administrative Burden: With routine protocol checks handled by eProtocol, Dr. Alan's team no longer had to waste time making multiple protocol revisions and resubmissions to get protocols approved. The platform ensured protocols were always audit-ready, minimizing audit preparation time and effort. Instead of scrambling to gather protocol documentation, they could focus on advancing research, knowing protocol management was actively maintained.

Key Takeaways 

For Dr. Alan’s team, effective protocol management is a game-changer. It shifts protocol management from a reactive task to a proactive process where protocols are continuously maintained, and issues are addressed as soon as they arise. This approach results in:

• Better protocol management with all changes properly logged
• Reduced manual workload on protocol administration
• Improved focus on research, rather than protocol management tasks

Effective protocol management system doesn't just ensure protocols remain compliant; it frees up valuable time for researchers to focus on innovation, data collection, and advancing studies.

Your Next Steps:

Ready to transform your research protocol management? Request a demo today to see how Key Solutions' eProtocol advanced features can keep your protocols compliant, with every change accurately tracked and all protocol management activities logged.

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