why-you-should-take-part-in-a-clinical-trial

Remote Audit Readiness - What Sponsors and Sites Often Miss

Few people genuinely enjoy an audit, but they are essential for touching base on protocols, methodologies and safety. Learn to be remote audit ready.
(3 min)

Most audit prep still assumes physical files, in-person access, and last-minute checklists. But remote audits are no longer a backup plan, they are common. And they require a different mindset. This post is not about general inspection preparation. It is a focused look at what makes digital audit readiness work.

Friction Points

  • Files in multiple systems with inconsistent version names
  • Access issues when auditors need read-only accounts
  • Audit trails scattered or stored separately
  • “Final” documents still awaiting a digital signature

Any one of these can throw off a remote audit. In person, someone might find the file or clarify a date. Remotely, you get email threads, delays, and unanswered questions.

Core Principles of Remote Audit Readiness

1. Centralise the audit layer

Not every file needs to be in one place, but what the auditor sees should be. That might mean:

  • A dedicated digital binder with links to source locations
  • Preloaded user credentials and walkthroughs
  • A one-pager that explains how to navigate the system

2. Test access early

Access failures are the most avoidable cause of audit delays. Simulate the login process. Use a clean browser. Ask a colleague to walk through it cold. Fix what breaks.

3. Be transparent about your digital stack

Auditors do not need marketing. They want clarity. Tell them:

  • Which systems were used for what
  • When each was implemented
  • What data flows between them

Documentation helps... but clear, accurate summaries help more.

4. Assume screen sharing will be part of the process

Even if read-only access is granted, plan for a walkthrough. Make sure someone from the team can:

  • Navigate the system comfortably
  • Show how audit trails are viewed
  • Explain why the data is where it is

A Word on People

Audits test systems, but they also test teams. Who answers the query? Who can explain the log? Who follows up? When preparing for remote audits, write out roles ahead of time. Confirm who speaks to what. Avoid silence on calls.

Do a test run... not the week before, but early. Invite someone from outside your team to simulate the audit path. You will find gaps. That is the point. Being audit-ready is not just about documents. It is about showing that your systems (and your staff) are in control.

Use the contact form here or email us at hello@trialflare.com

Related Posts

PII and Data Privacy in Human Trials
Protecting participants, their identity and their data in human trials. Be responsible and do the right thing.
(4 min)
21 CFR : Making Sense of it All
We talk a lot about 21 CFR (especially part 11) in clinical research - there's so much more to it than meets the eye
(5 min)