Audit-readiness isn’t a one-time project—it’s a mindset backed by daily habits, smart systems, and team accountability. The more proactive your site is, the less you’ll need to panic when the FDA (or a major sponsor) shows up at your door.
Avoid 483s by staying organized, responsive, and transparent—all year long.
We’ve created a quick checklist of daily, weekly, monthly, and yearly tasks for your regulatory specialist to use as a template to get your site started with audit preparedness. Use this as a starter and add tasks that fit your research site’s workflows & needs!
Daily Tasks
- Check for missing signatures or incomplete documents
Review any newly generated forms, logs, or source notes to ensure they’ve been signed and finalized appropriately.- Pro Tip: Set up automated signature alerts to notify PIs and staff of outstanding items before they become compliance issues.
- Confirm version control on study-critical documents
Make sure you’re always working off the latest version of protocols, ICFs, and SOPs—especially after amendments.- Pro Tip: Use a version-controlled eReg system that restricts use of outdated files and maintains full audit trails.
- Log protocol deviations or safety events immediately
Don’t wait until the end of the week. Real-time documentation ensures you don’t miss critical reporting windows.- Pro Tip: Build custom deviation logs that auto-flag issues for reporting and follow-up.
- Verify informed consent compliance
Confirm that patients are signing the correct ICF version and that all required sections are completed.- Pro Tip: Use eConsent tools that enforce correct versioning, track signer completion, and log activity instantly.
Weekly Tasks
- Conduct source data reviews for recently completed visits
Make sure data aligns with protocol requirements and that any red flags are addressed proactively.- Pro Tip: Use real-time data validation to catch errors before they get to your CRA.
- Check training compliance across team members
Ensure everyone delegated to a task is appropriately trained and current on required certifications.- Pro Tip: Create automated staff training logs and receive alerts on expiring certificates.
- Perform internal spot checks on regulatory binders
Choose one or two studies and do a quick review of their ISFs—look for outdated files, missing approvals, or inconsistencies.- Pro Tip: Build in recurring task assignments for team members to share the review responsibility.
Monthly Tasks
- Audit eLogs and delegation records
Reconcile DOA logs against task performance to ensure your records match reality.- Pro Tip: Use digital delegation logs that auto-update as staff complete tasks.
- Cross-check I/E criteria documentation
Review your subject eligibility documentation to ensure proper flagging and protocol adherence.- Pro Tip Leverage eSource forms with embedded logic rules that highlight inconsistencies automatically.
- Review sponsor correspondence
Archive key communications and verify required follow-ups have been logged and completed.- Pro Tip: Store email uploads and correspondence directly in your eReg folder structure for easy access during audits.
- Prepare for upcoming monitoring visits
Ensure files are organized, PI sign-offs are complete, and that remote access permissions are updated as needed.- Pro Tip: Enable role-based remote monitoring so sponsors see only what’s relevant, with zero scrambling on your end.
Yearly Tasks
- Conduct a full internal audit
Simulate an FDA inspection or sponsor audit by selecting random studies and reviewing them end-to-end.- Pro Tip: Use customizable audit-ready reports that summarize study status, overdue tasks, and document completeness.
- Update and review SOPs
Reflect any regulatory changes, system upgrades, or workflow adjustments—then retrain staff accordingly.- Pro Tip: Build SOP templates into your document library and push updates across all studies simultaneously.
- Evaluate system integration and gaps
Assess whether your current tools (CTMS, eSource, eConsent, eReg) talk to each other. Look for redundancies or data silos.- Pro Tip: Choose a fully integrated platform to reduce duplication, speed up workflows, and avoid discrepancies.
Download a PDF of Our Checklist!
Audit Readiness Checklist for Sites
If you’re looking for a new solution to automate your regulatory compliance and reduce time spent with tedious and repetitive tasks, reach out to Clinical.ly to learn more about our Research Suite, including eReg, eSource, eConsent, ClinicallySign, & ClinicallyPay!