No matter if you’re preparing for an imminent clinical trial inspection or if you’re just bracing for a mock inspection, it is vital for you and your team to be prepared. Even so, establishing a culture of readiness can be difficult with each step presenting its own challenges.
At ADAMAS we’ve been at the forefront of industry best practice for over 24 years and have conducted audits in over 100 countries for more than 750 international clients. After thousands of hours of independent consultancy and collaboration, we’ve been able to highlight some of the key missteps that are made and compile a list of some of the most important tips for Inspection Readiness.
1. Ensure that your TMF is Complete with an Accurate TMF Plan and TMF Map
Your TMF plan must include the type and frequency of quality checks, document content requirements, the roles and responsibilities of internal and external partners across the study. Your TMF Map should accurately reflect the content and location of all essential documents. As such, both documents require regular review and updates in order to ensure that your TMF is in a constant state of inspection readiness for your organization.
Comments from an ADAMAS consultant: “The frequent deficiency that we find at Mock Inspections is that TMF maps are not accurate or complete. It is the key document to guide inspectors through the TMF and when documents are held at vendors or incorrectly placed in multiple systems it causes problems. The map must be as accurate as possible to ensure a smooth and streamlined inspection”
2. Know Your Responsibilities for Sponsor Oversight and Have the Right Documentation
As a sponsor, you will be expected to demonstrate oversight of the trial while it is in progress even when steps are outsourced to a Contract Research Organization (CRO). To ensure full inspection-readiness in this area, you should ensure all key oversight documentation is in place, including contracts, vendor oversight plans, oversight of vendor deliverables, signed trial documents, meeting minutes, correspondence, and documentation of key trial decisions. Knowing your responsibilities is key whenever any part of your trial is not conducted by an in-house resource.
3. Be Prepared for Questions at Your Presentation
The presentation is the ideal opportunity to walk inspectors through the trial and your storyboard of events. However, where many fall down is by having the wrong Subject Matter Experts (SMEs) in attendance or they are not fully prepped for the questions they may face. It is crucial that your SMEs are capable of answering questions competently and explaining your quality systems, processes, and study conduct records. Additionally, they should be prepared to clearly explain any areas of risk that you have identified.
Comments from an ADAMAS consultant: “The inspector can ask any question they want and the presence of any SME at the presentation opens them up to questioning. If they cannot fully answer a question or indicate that it is someone else’s knowledge area (and that person is not present) this is where the lack of knowledge is exposed. For presentations, it is essential that they outline the key process with key study dates/information and you are prepared to answer inspectors’ questions on your presentations. Ensure you have the right individuals presenting and on hand. You need to do your homework and storyboard your study conduct to make sure you’re hitting the key dates and events. It’s all about managing risk and being prepared”
4. Ensure Document Requests are Streamlined
Whether it’s QMS documents such as SOPs and working practices, audit program information, corrective action reports, preventative actions reports, misconduct reports, or training records for employees and contractors, inspectors can ask for any documentation that they feel is relevant to demonstrating overall compliance. All your documentation should be available to be called by an inspector at any point during the process with staff prepared to discuss and demonstrate review, approval and dissemination processes when necessary. Inspectors may also ask for documents to be provided either physically or digitally so be ready to send your paperwork in multiple formats.
Comments from an ADAMAS consultant: “At this point, one of the most common missteps that we see are delays in providing documentation as it wasn’t properly prepared or available. Or, another common error is that the documentation that is provided isn’t what the inspector actually requested, or didn’t fully evidence what they were looking for.”
5. Quality & Timeliness are Key
A quality control check must be implemented to ensure documents provided to Inspectors are accurate and complete. For an on-site inspection, you would have the “War room” where you can check and recheck that your documents are in place and fully finalized. The same level of attention needs to also be in place for a remote inspection. Any gaps in readiness need to be identified in advance while there is still time to take corrective actions and develop a strategy for addressing any issues identified, whether it’s getting a signature for a document or obtaining missing paperwork. It is important that before any paperwork is put in front of an inspector that you have confidence that it is complete, accurate and that you have full knowledge of its potential effect on critical data.
Comments from an ADAMAS consultant: “It is a frequent observation during mock inspections that documentation has incomplete information or a missing signature. There can be over 200 documents requested during an Inspection in any trial but every document must go through a QC before it’s put in front of an inspector. It’s one of the most critical steps to demonstrate your compliance”
6. Protocol Deviations must be Fully Evidenced
Whether a deviation from the protocol was unplanned or was planned for subject protection, it must be accurately recorded and its severity evaluated and fully documented. Each institutional review board/ Ethics Committee is likely to have its own reporting criteria, which the sponsor should follow, however, once it has come to a time for inspection SMEs should be prepared to show the timeline of actions and progress to date to ensure that deviations were properly identified, addressed and then evidenced.
Sponsors must be able to demonstrate an accurate overview of events with proof of categorization, how decisions for categorization were made and any other relevant information within their CSRs.
By addressing these issues now, you will eliminate potential delays and promote a culture of readiness as you approach your next inspection. For more information on how you can leverage our knowledge and create a culture of Inspection Readiness within your organization email us at: firstname.lastname@example.org