Clinical Trial Site Emergency Protocol Form

Ensure Clinical Trial Continuity During Emergencies with Paperform

When an emergency strikes—whether it's a natural disaster, facility closure, or unexpected crisis—clinical trial sites face unique challenges. Beyond standard business continuity concerns, research teams must verify participant safety, maintain strict protocol compliance, preserve critical study data, and notify sponsors immediately. This Clinical Trial Site Emergency Protocol Form provides a structured, compliant framework to manage all these requirements in one centralized workflow.

Why Clinical Research Sites Need Specialized Emergency Forms

Clinical trials operate under rigorous regulatory oversight from the FDA, IRB/IEC, and study sponsors. During emergencies, sites must document:

• Participant safety status and welfare checks for all active enrollees
• Protocol deviations caused by the emergency
• Investigational product security and temperature excursion reports
• Data integrity measures to protect source documents and eCRF systems
• Sponsor and IRB notification within required timeframes
• Site reopening procedures and protocol resumption plans

Traditional emergency response tools aren't built for the unique compliance requirements of clinical research. This Paperform template transforms your emergency response into a documented, auditable process that satisfies regulatory expectations while protecting your most important asset: participant safety.

How This Template Protects Participants and Protocols

This comprehensive form guides your site team through emergency response with conditional logic that adapts to your specific situation:

Immediate Crisis Assessment: Capture the type, severity, and impact of the emergency with fields designed for clinical research contexts—from weather events affecting participant visits to facility issues impacting investigational product storage.

Participant Safety Verification: Document systematic welfare checks for all enrolled participants, track evacuation status, verify medication access, and identify participants requiring immediate intervention or study discontinuation.

Protocol Continuity Planning: Record which study procedures can continue, document necessary protocol deviations, and create a clear plan for resuming normal operations with full regulatory compliance.

Regulatory Notification Workflow: Automatically capture all information needed for sponsor notification, IRB reporting, and regulatory agency communication, ensuring you meet tight reporting deadlines even during chaotic situations.

Data and Product Integrity: Verify the security of source documents, eCRF systems, biological samples, and investigational products, with specific fields for temperature excursions and chain-of-custody concerns.

Seamless Integration with Your Research Infrastructure

Paperform's powerful integration capabilities mean this emergency form doesn't live in isolation. Connect your submissions to:

• Clinical trial management systems (CTMS) to auto-log emergency events
• Sponsor notification email sequences triggered by form submission
• Slack or Microsoft Teams for instant site team alerts
• Google Drive or SharePoint to automatically file emergency documentation
• Stepper workflows to route different emergency types to appropriate response teams (medical monitor for participant safety issues, quality assurance for protocol deviations, etc.)

With Papersign integration, you can immediately generate formal incident reports requiring site PI signatures, turning your emergency documentation into sponsor-ready reports within minutes.

Built for Multi-Site Research Organizations

If you manage multiple clinical trial sites, Paperform's Agency+ plan lets you deploy customized versions of this template across your network while maintaining centralized visibility. Each site can submit their emergency reports to a unified dashboard, giving your leadership team real-time crisis visibility across your entire research portfolio.

SOC 2 Type II compliance and robust data residency controls mean your sensitive participant safety data and proprietary protocol information stay secure, even during a crisis.

Why Choose Paperform for Clinical Research Forms

Professional, Compliant Presentation: Create forms that match your institution's branding while maintaining the professional tone required for regulatory documentation.

Conditional Logic for Complex Workflows: Only show relevant fields based on emergency type, participant impact, and protocol status—reducing errors and completion time when every second counts.

Mobile-Ready Crisis Response: Site staff can complete emergency reports from any device, whether they're working remotely during an evacuation or documenting issues from temporary locations.

Automatic Audit Trail: Every submission is timestamped and stored with complete response history, creating the documentation trail required for regulatory inspections.

No IT Department Required: Research coordinators and site managers can build, customize, and deploy emergency forms without coding or waiting on technical resources.

Who Benefits from This Template

This Clinical Trial Site Emergency Protocol Form is specifically designed for:

• Clinical research coordinators managing day-to-day trial operations
• Site principal investigators responsible for participant safety and regulatory compliance
• Clinical research organizations (CROs) supporting multiple sponsor studies
• Academic medical centers running complex research portfolios
• Specialty research sites in oncology, cardiology, neurology, and other therapeutic areas
• Quality assurance teams documenting protocol deviations and corrective actions

Whether you're running Phase I safety studies or large-scale Phase III trials, this template adapts to your specific emergency response needs while maintaining the documentation rigor that sponsors, IRBs, and regulatory agencies expect.

Get Started in Minutes

Start with Paperform's free plan to customize this template for your site's specific protocols and SOPs. As your research program grows, scale up to Pro or Agency+ plans to unlock advanced automation with Stepper, turning emergency reports into complete workflows that assign tasks, generate sponsor notifications, and track resolution—all without writing a single line of code.

When crisis strikes, your clinical trial site needs tools that work as hard as your team does. This Paperform template ensures that even in the most challenging circumstances, participant safety and protocol compliance remain your top priorities.