Best Practices for Preparing for Your TMF Inspection
The clinical trial regulatory inspection—among the most pivotal steps in reaching approval—is going through an evolution. Regulatory authorities across the globe are updating their requirements to keep up with new eClinical technology, the increasing complexities of clinical trials, and a new, unexpected variable: COVID-19.
As the pandemic has made on-site inspections challenging across most of the world, remote inspections have become vital to keeping studies moving forward. How does this change the way we prepare for inspections, and how do we address the new challenges a remote inspection could bring?
Whether your inspection is remote or on site, one best practice remains the same: Don’t wait until the last minute to think about inspection readiness. Start planning long before you get that letter from the inspectorate.
One of the first things to look at is your eTMF. Focus on your essential documents. Run completeness reports to make sure you have every document you need, and work with your vendor and internal quality assurance (QA) team to perform audits. It’s important to check for anything that is missing or incorrectly filed on a regular basis. Also be sure that other departments and groups are getting the content you need into the TMF. All of your stakeholders must understand your TMF’s value, not just those primarily responsible for it.
Proactively talk to people in your organization—like department heads and clinical trial administrators (CTAs)—to find out what their concerns are about the upcoming inspection. Next, align everyone on how to approach any identified gaps, like missing documents or incomplete trainings.
Establish a core inspection team to own the key responsibilities for your inspection, such as someone responsible for document requests, subject matter experts (SMEs), and more. Make sure your team knows the inspection plan and understands their responsibilities.
As with an on-site inspection, it’s never too early to start planning for a remote inspection. When you align with your team early, you have time to fine-tune your procedures and policies, and prepare answers to more questions inspectors may have for your team.
Setting and Location
COVID-19 has placed incredible restrictions on the key logistics that make an on-site inspection possible, including limitations on travel, social distancing, and limited access to facilities. You may have already had plans for an on-site inspection in play, but now you’re faced with the challenge of going remote for the first time.
Answering these questions can help your inspection seamlessly transition to a remote environment: How are you sharing documents electronically? Will your inspectors need extra documents ahead of time? Can you give inspectors more time to view different documents or procedures, trainings, and policies?
How is your team speaking to one another? What types of programs are you using to ensure documents that are going from a virtual back room to a front room are properly quality checked?
Not being able to work with your team in the office means you’ll miss out on face-to-face discussions that were valuable to your inspection prep, but that doesn’t mean you can’t still have effective conversations virtually. Study teams who have gone remote have found that virtual tools such as Slack or Google Hangouts still enable them to have those valuable conversations and work together effectively.
Make sure you understand which systems will be impacted well in advance of your inspection. If you have multiple systems—including an eTMF, learning management system, or standards of procedure (SOPs) housed in an electronic quality management system, review which systems are in use and identify those your inspector needs to access.
Many inspectors want direct access to your systems, and they’ll expect each system to be easy to use. If you’re handling everything virtually, how do you train your inspectors and ensure they have everything they need to access your systems? Create and share quick reference guides or online demos to help your inspectors get up to speed.
Handling document requests virtually can be one of the bigger challenges of a remote inspection. How will you provide the proper documents to your inspectors in due time? How will you provide documents that are not in the eTMF?
Since the traditional roles of an on-site inspection don’t apply to a remote one, it’s best to do test runs to figure out the optimal way to handle your documents so it’s an easy process come inspection time.
As mentioned earlier, online collaboration tools can be a great way to ensure quick communication between your inspection team members. Some study teams have assigned back room and front room teams to their own group chats. This enables the back room team to pull requested documents, push them to another system, and notify the front room when a document is ready for the inspector’s review.
Whatever mechanisms you choose to make your virtual document requests run smoothly, run a few mock inspections to ensure your system works and your team feels comfortable with the process.
TMF Best Practices
Your eTMF—like a paper one—tells your study’s story. It needs to contain any documentation, data, and metadata required to conduct your study. This is why it’s so important to make sure your eTMF is inspection ready. Can you find all of your documents in a quick, easy format? If you have documents in a different system, is that noted? Is everything filed correctly and quality checked? Make sure you can answer these questions.
It’s also important to have all of your stakeholders review the content they own. In fact, it’s best to push your stakeholders to review and update content on an ongoing basis to keep a contemporaneous TMF. Work with your stakeholders to make sure they submit their documents on time. Create an SOP with tangible dates and timelines that are reasonable. Hold people to your study goals and timelines with documented guidelines.
The lead inspector for your study should provide you with a detailed agenda with planned sessions and time slots. It’s even more critical with a remote inspection for everyone to be aware of when each session and time slot is taking place.
Some sessions will require SMEs to deliver presentations, so be sure to identify who your SMEs are, as well as backups in case your primary SMEs are not available. How do you handle those ad hoc requests from inspectors to speak with more people?
With remote inspections, your team members won’t be just down the hall if you need them. Build a contact list of all your SMEs and let them know they’re on call. Give your SMEs a heads-up when they’re moving up in the queue for inspection interviews. Again, be sure to hold virtual calls to prep your SMEs for the types of questions inspectors will ask. Educate them on their roles, what they’ll talk about, and what they should say. This is another area where conducting mock inspections is extremely helpful.
As we continue through the COVID-19 pandemic, remote trial inspections may become the standard. Although this change is huge for those of us used to on-site inspections, careful preparation and fluid communication still remain at the roots of success during your inspection, no matter the setting.
For more help with remote trial management and preparing for remote inspections, contact us at firstname.lastname@example.org.