Strengthening IRB Protocol Submissions with AI

As a Principal Investigator, you’ve invested months into designing your study, securing funding, and assembling your research team. But when it comes time for the IRB submission, you’re met with revision requests: discrepancies in study duration, inconsistent participant compensation, or missing elements in the consent form.

These frequent back-and-forth revisions delay the approval process, and manually finding every discrepancy yourself is challenging and time-consuming after drafting pages of protocol documentation.

That's where eProtocol with AI-enhanced capabilities comes in. This AI-enhanced platform combines data analytics and AI to act as your pre-submission quality check. It identifies inconsistencies, flags missing elements, and ensures regulatory requirements are met before your protocol reaches the IRB committee.

In this article, you’ll learn how this AI-powered platform can help you effectively document and manage protocol submissions. So, let’s get started. 

Structured Support for Protocol Creation & Documentation

Here are a few features of eProtocol:

1. Template-Based Consent Form Development

Rather than investigators starting with blank documents, eProtocol provides structured consent form templates organized by study type and institutional requirements.

These templates guide investigators through required regulatory elements, ensuring that sections addressing purpose, procedures, risks, benefits, alternatives, confidentiality, and voluntary participation are all present in the document.

If a required section is left unanswered, the system alerts the investigator before submission. If information that should match across sections doesn't match, it's flagged for correction.

Although investigators still need to explain their specific research clearly, eProtocol detects structural gaps and obvious inconsistencies before protocol submission.

Also, version control becomes automatic rather than manual. The system tracks what changed, when, and by whom. When an IRB reviewer asks "what's different between version 2 and version 3?"—a common question during amendment reviews—the documentation is immediately available.

For institutions managing multi-site studies, template-based approaches help maintain consistency in core study information while accommodating site-specific requirements (local contact information, institutional affiliations, etc.).

2. Protocol Review Workflow Support

IRB operations involve complex workflows — from internal pre-review and initial submissions to committee assignments, member reviews, deliberations, decision communication, and post-approval monitoring. 

eProtocol supports these processes with robust workflow management tools that help standardize and streamline IRB operations. The system:

• Guides investigators through required documents and information for new submissions, modifications, continuing reviews, and adverse event reports.
• Provides PIs real-time visibility into the status of their submitted protocols, helping them stay informed and responsive throughout the review process.
• Supports committee coordination by enabling visibility into protocol assignments, helping manage reviewer workload, and matching protocols to members with appropriate expertise.
• Provides standardized checklists and forms to ensure consistent evaluation of required review elements.

3. Approval Tracking and Compliance Monitoring

Post-approval, research teams must monitor continuing review deadlines, submit required modifications, and maintain accurate records for regulatory audits. eProtocol supports this through:

• Automated reminders for continuing reviews and other time-sensitive submissions. The system tracks approval anniversary dates and notifies investigators in advance.
• Real-time status visibility for investigators, department administrators, and IRB staff — reducing email inquiries and improving coordination across the review process.
• Automatic audit trails that capture actions and timestamps, generating the documentation regulatory inspectors require during audits.

Additional Capabilities of eProtocol 

Apart from the capabilities mentioned above, research institutions can avail incorporating AI capabilities into eProtocol for specific, well-defined tasks where pattern recognition and systematic checking add value.

• Protocol Consistency Analysis

One of the AI-enhanced features involves analyzing protocols for internal consistency. The system scans submission documents looking for information that should match across sections, but doesn't.

For example:

• Study duration is mentioned in different lengths in different sections
• The number of study visits is inconsistent between the timeline and procedures
• Participant compensation amounts vary across documents
• Medication administration schedules are described differently in different places

When the system identifies potential inconsistencies, it flags them for investigator's attention. 

• Consent Form Language Analysis

AI-powered readability analysis evaluates informed consent documents for language complexity. Federal regulations require that consent information be presented "in language understandable to the subject" (45 CFR 46.116).

The system can assess reading level (using established readability metrics) and flag sections with particularly complex language or technical terminology that might need simplification.

• Literature and Regulatory Recommendations

During protocol preparation, AI-powered search capabilities can help investigators identify:

• Previously approved studies at their institution or peer institutions with similar research aims
• Relevant published literature supporting the study's scientific rationale
• Applicable regulatory guidance based on study type

These insights provide a valuable starting point, helping researchers discover relevant resources they may not have otherwise identified.

• In-Application Support

An AI-powered knowledge system provides answers to common procedural questions:

• "What documents are required for a modification submission?"
• "When does a change to my protocol require IRB approval?"
• "How do I report an unanticipated problem?"

For routine, factual questions with straightforward answers, the knowledge system provides immediate responses. This reduces the volume of routine inquiries while ensuring that investigators can get quick answers to basic procedural questions.

Read more about: 7 Ways AI Can Improve Your Research Team’s Productivity

Real-World Benefits of AI-powered Protocol Submissions 

Let’s explore the benefits of AI-powered protocol submissions for various stakeholders. 

For IRB Administrators:

• Less time spent on administrative completeness checks frees up capacity to support committee operations, consult with investigators, and focus on complex cases requiring expert attention.
• Improved documentation and audit trails increase confidence during regulatory inspections and accreditation reviews.
• Standardized workflows help train new IRB staff and ensure consistency even as personnel change over time.

For IRB Committee Members:

• Protocols that undergo structured checks before review allow committees to focus on ethical evaluation rather than catching procedural errors.
• Standardized review processes ensure regulatory criteria are addressed consistently, supporting fair and defensible decisions.
• Clear summaries of changes in amendments help reviewers focus on what’s new instead of re-reading the full protocol.

For Investigators:

• Structured templates and built-in validation reduce avoidable errors and revision cycles, streamlining initial submissions and reducing the frustration.
• On-demand access to regulatory guidance and institutional procedures lowers uncertainty during protocol preparation.
• Real-time status tracking improves transparency and reduces anxiety about where a submission stands in the review process.

For Institutions:

• More efficient IRB operations improve research throughput without compromising ethical oversight.
• Comprehensive documentation strengthens compliance with federal regulations and accreditation requirements.
• Standardized processes reduce institutional risk tied to inconsistent reviews or missing documentation.

Want to see eProtocol in action? Reach out today to schedule a demo and discover how eProtocol can enhance your research compliance and administrative operations.

Frequently Asked Questions