Advarra Electronic Regulatory Documentation Software

Advarra Electronic Regulatory Documentation Software:

• The time has finally come! R&D has purchased the Advarra E-Reg module, which integrates with Clinical Conductor, Advarra IRB, and CC IRB/PRISM
• The R&D team is currently working with Advarra through the implementation phase and 21 CFR Part 11 compliance validation
• Summer 23 – E-Reg will be rolled out to study teams and training sessions will be held

Benefits of E-Reg:

• Master Delegation Logs – Users have responsibilities delegated by ROLE rather than specific study protocol
  • Ex) CRC Role is delegated tasks such as consent, data collection, specimen collection, etc.
  • Ex) PI Role is delegated study oversight, eligibility confirmation, AE/SAE assessment/causality
  • Delegated responsibilities then flow to each study protocol that is assigned in E-Reg, automating the DOA log process
• Electronic Signatures for all documents
• No more paper binders to move around/keep track of
• Centralized reporting on training due dates, CVs, licenses, upcoming deadlines, etc.
• Remote monitoring capabilities
• Automatic document upload from Advarra IRB and PRISM (approval documents, protocols, consent forms, etc.)

Implementation:

• New studies will be built into E-Reg once rollout and training have been completed
• Older studies that will remain open for several years will gradually be converted
• Older studies that are approaching closeout (within a year) will remain paper-based

Information for Principal Investigators:

• E- Reg is mobile optimized for easy access to sign off on regulatory documents via your mobile phone
• Notifications can be customized as daily or weekly to meet your preferences