Are You Ready for an Unplanned Site Inspection?

Posted by Paul Buckmaster on Mar 8, 2021 2:56:30 PM

The following is an excerpt from our eBook ‘How to Improve Site Compliance’. Click here to read the full eBook.


Unplanned site inspections by regulators are becoming increasingly common. You can help your sites stay inspection-ready by ensuring that trial documents and data are categorized correctly and quickly accessible across all your clinical sites.


Questions to ask when considering your sites’ inspection readiness:

  1. Is your trial documentation all in one place?
  2. Are you tracking everything you need to?
  3. Can you show quality management of your trial?


In focus groups, sites have reported some of their biggest challenges when it comes to inspection readiness:

  • Documentation may consist of the protocol and its amendments, but also extends to technical information, communications to investigators, safety reports, training records, checklists, consent forms, and monitoring templates. A centralized repository for hosting this information, with version control management and the ability to generate customized reports, can facilitate this aspect of inspection preparation.
  • Demonstrating traceability when it comes to planned or unplanned inspections is an integral part of being instinctively compliant. In 2016, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) published an addendum to its GCP guidelines that placed more emphasis on the use of real data and insight to manage and design trials, and encouraged greater use of technology. One of the core requirements of any electronic system within GCP is that it include audit trail functionality; meaning a system – used by sponsors, CROs, and sites alike to share data and to communicate – that can record when a communication has been read or a task completed, and facilitates effortless data tracking when it comes to inspection time.
  • Documented evidence of on-boarding the study team and providing training are requirements in the latest GCP guidance. An audit trail to show that information has been received and training has taken place is as important as the preparation of these resources in the first place. Recording this information in one place helps inspectors quickly identify that sites have been fully on-boarded, and that everyone is following the trial protocol and its supporting documentation.


Get Off to a Good Start by Focusing on the Site Initiation Visit (SIV)

Starting the trial off right with a comprehensive and interactive SIV is another way to jump start success. During an SIV, the sponsor (often through Clinical Research Associates [CRAs]) ensures that the site team has everything needed to begin the study, including:

  • Ensuring site staff have been fully trained in – and understand – the trial protocol and their responsibilities in delivering it
  • Verifying the site is ready to start enrolling participants

Using online training tools that can aid understanding of the protocol can be effective for engaging site teams and supports fewer protocol deviations, cleaner data, faster recruitment, and less time spent on resolving issues due to misinformation. Ultimately, using an online system can result in faster study start-up and greater efficiencies throughout the study.

We’ll talk more about technology enablement for sites, but first, let’s take a deeper look at the site perspective.


Focus on the Site Perspective

Site staff are fundamental to the success of any clinical trial and are responsible for the day-to-day task of ensuring that there are no protocol deviations, while working to ensure participants have a positive trial experience. Sites report they are continuously asked to do more with less; left unchecked, this environment can make them feel as if they are not part of a well-supported team.

One way to keep site staff feeling like appreciated team members is to be proactive about collecting their thoughts and experiences during the trial. We’ve held focus groups to get sites perspective. Here are some site comments from a recent Longboat site staff focus group:

  1. Clinical trial protocols are increasingly complex, with more visits, procedures, and patient populations. Because of the extra time involved, sites can now process only one or two patient visits in a day, as compared to four or five visits per day 10 years ago.
  1. Amendment rollout is often disorganized. Much of the communication regarding a new version of the protocol, for example, is done via email, and these updates and their associated approvals are often missed.
  1. Site staff want more focused and interactive SIVs and feel that face-to-face investigator meetings are important for discussion and interaction with peers. There was general agreement that an investigator meeting should cover key procedures and eligibility criteria in more detail, with less time spent on general training (e.g., ICH GCP). Replacing elements of the meeting that are not reliant on face-to-face engagement with other modalities (e.g., online learning for general training) could be a great solution.

Now that you know what they are thinking, how do you get them engaged?

The above is an excerpt from our eBook ‘How to Improve Site Compliance’

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Topics: clinical trial training, Study Team, Inspection, Readiness

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