What are the steps to prepare for an RTSM regulatory inspection?

Here are some key principles I’ve compiled from nearly two decades of quality management experience in clinical software and services, including hands-on experience across scores of IRT inspections and audits.

1. Define clear roles and responsibilities

We all know that inspections are fast paced, but keep in mind that they are also risk based. Inspectors want to see evidence of client oversight and system validation. Keep all your data and processes organized and accessible.

Understanding your team’s responsibilities during a clinical trial can save everyone a lot of time during a live inspection. Clearly define who is responsible for the data, as well as what will be reviewed in an inspection and why, so that if the time comes, you and your team can efficiently address questions and manage risks.

Remember: The principal investigators hold responsibility for the subject and patient data. Any data changes during an inspection must be made with PI awareness and approval, always prioritizing patient rights and good clinical practice principles.

2. Demonstrate data integrity

Regulations require audit trail reviews, so it’s important to prepare the person who is responsible. Given that IRT is a highly transactional system, the frequency of reviews may differ from other systems. Audit trails are not just a regulatory checkbox — they help you and the inspectors investigate any issues that arise.

Data integrity is another important element in an inspection. Underlying documentation and strong control procedures are critical to the outcome of your inspection and throughout the study lifecycle. Ensure data-integrity elements are built into your quality management system.

Figure 2. Ensuring data integrity and reliability

New regulatory guidance

In 2023, the European Medicines Agency (EMA) released new guidance on computer systems and electronic records that are used in clinical trials. This document is essential to ensuring a smooth inspection. We strongly recommend to our clients that they conduct a gap assessment with this document in hand. These assessments allow you to understand your audit trails in the context of compliance risk. Look at the guidance, identify your own areas of weakness and strength, and make sure you can readily address each point within the EMA document. The earlier you establish a position on these points, the better.

3. Train and adapt your teams

   Training your teams should go beyond compliance — every team member should understand how their work supports inspections. Some additional tips include:

   • Ensure everyone on the team can to speak to their roles and provide examples of their work.
   • Develop checklists and review them ahead of inspections.
   • Prepare SMEs to not just perform tasks but also explain them clearly. Offer feedback to help them strengthen their communication and audit readiness.
   • Conduct at least one mock inspection. While time consuming and potentially disruptive, a mock inspection will allow you to see how people react to high-pressure situations and adjust your plans accordingly.
4. Maintain the blind

   As clinical trials grow in complexity, randomization in IRT systems faces increased scrutiny. It’s essential to know your audience and maintain the blind. Inspectors are usually considered unblinded, but your clients often are not. Always confirm who is present in open sessions before sharing sensitive information and ask blinded individuals to step out if needed. Be ready to share randomization assignments and ensure you have documented procedures for setup, software development life cycle processes, system changes, and updates.

5. Take immediate action after inspection notification

   If you’ve been notified that an inspection is going to take place, here are the actions you should take to help the process go smoothly:

   • Know what the inspectors want. Understand which agency is conducting the inspection and where the inspection will take place. Is it directly at a client headquarters? A clinical trial site? A CRO? This will help shed light on what the inspectors will be looking for.
   • Create processes that are easy to follow. Define your contact lists with designated backups. Ensure processes can be picked up and followed easily by any team member.
   • Determine internal timelines for inspection requests. If you don’t have a response to a question or request received during an inspection, check in with the inspectors to let them know you’ve received the request and will keep them updated. Encourage everyone involved to do the same.
   • Review responses. Ensure that a qualified person, either from management or from quality assurance, is reviewing responses to ensure they are clear and well written and avoid technical jargon.

These recommendations and steps — from data access to response review — are closely tied together. It’s critical to remember that we don’t implement these measures just because they’re required by regulations but rather because they also make our day-to-day work easier. When we remain organized, with consistent oversight, data integrity, audit trails and controls, we can be prepared for any inspection.

How can an RTSM system provider help?

Knowing you work with an IRT system and services provider that offers responsive, knowledgeable support can also help alleviate some of the inspection burden. For a more detailed discussion on this topic, please access this on-demand webinar I recorded in March 2025:

Ensuring a successful regulatory inspection with support from your IRT provider

You can learn more and contact us about IQVIA IRT at www.iqvia.com/IRT.