Staff Training & Document Exchange

The Staff Training & Document Exchange Activation Module from ProofPilot is a comprehensive clinical trial site activation solution designed for sponsors and study teams who need to move beyond one-time, ineffective training. Recognising that ninety percent of sites learn how to execute a protocol on the first few patients due to inadequate preparation, ProofPilot delivers ongoing, multifaceted support that drives protocol compliance, reduces site burden, and improves satisfaction across all stakeholders.

The platform enables seamless and continuous collaboration between sponsors and sites through formal interactive training, on-demand resources powered by intelligent search, and real-time communications — ensuring studies are executed flawlessly from activation through completion.

Staff Training Capabilities

• Upload and assign site-specific and role-specific training materials, including searchable, customisable documents for offline learning and videos for multisensory engagement.
• Set due dates and expiration dates for training assignments, and manage training versions with automated reassignment when content is updated.
• Generate and store completion certificates automatically, ensuring consistent and auditable training records across all sites.
• Use a WYSIWYG editor to apply adult learning principles, creating interactive training content with custom images, videos, and text styling that replaces hard-to-retain bullet-pointed slides.
• Design assessments with tailored feedback, configurable passing thresholds, and certificate issuance only upon successful completion — driving better knowledge retention and protocol compliance.
• Provide predefined visit guidance templates that outline patient visit-by-visit workflows and technologies, ensuring consistency and compliance in study conduct across all sites.
• Eliminate confusion, burden, and errors by standardising study visit procedures for both site staff and patients.

Document Exchange Capabilities

• Simplify the distribution and tracking of study documents sent to sites, accommodating the complexity of multi-country, multi-time-zone, and multi-language protocols.
• Streamline the capture of necessary documents from sites as part of study start-up and ongoing study maintenance.
• Reduce site burden and administration costs through a centralised document management workflow.
• Increase site and study team satisfaction with a next-generation tracking solution.
• Integrate documents captured from sites directly into the eTMF for regulatory compliance and streamlined record-keeping.
• Monitor document task completion rates at the site level and download completed site documents from a fully centralised platform to accelerate study start-up.

Visit Overview and Milestone Management

• Create detailed visit plans that promote compliance and simplify workflows with centralised instructions for site staff.
• Configure milestone templates by country, protocol, or site type to accommodate diverse study structures.
• Generate audit-ready reports and monitor milestone performance centrally across all sites.
• Milestones completed in the Study Startup Planner can automatically update statuses in a connected CTMS, eliminating duplicate data entry.

Platform Integrations and Compliance

• eTMF integration securely stores and manages training documents and certifications, archives communication logs and attachments, and ensures regulatory compliance through seamless record-keeping.
• CTMS integration enables automatic status updates from completed milestones, reducing administrative overhead.
• Training materials, certifications, and communication records are centralised in one streamlined workflow for easy distribution, tracking, and audit readiness.

ProofPilot's Activation Module sits within a broader Clinical Trial Experience Platform that centralises and simplifies recruitment, conduct, and communication for sponsors, patients, and sites. Clients including top-ten and top-twenty pharma companies have reported significant improvements in compliance, cost savings, and study efficiency when using ProofPilot's integrated approach to site activation and ongoing support.