What does TMF inspection readiness mean? What is required to get inspection-ready? And what technology can help you be inspection ready at any time? These were the questions answered at our recent webinar with our partner Arithmos. So whether you’d like a refresh or missed it, here’s a summary.

Understanding What TMF Inspection-Readiness Means

Antonello Cervone, a Senior Business and Technical Consultant at Arithmos, kicked off the webinar explaining inspection readiness. He said that companies must operate with high standards daily, and they can be inspected regularly or unannounced. These are official reviews of the facilities, documentation, records, etc., by national and international health authorities.

Ultimately, pharma and biotech companies must be ready and prepared to welcome inspectors at any time. And that means these companies need to shift from being reactive to audits to being proactive.

Cervone said that not maintaining an inspection-ready trial master file (TMF) is risky. The TMF could have invalid data, and the remediation costs of non-compliance are not small. Being reactionary leads to allocating resources to fix work that has already been done before the auditor. In some cases, if the TMF is not in proper order, the study could be stopped.

Another point Cervone made is that planned audits are becoming rare. Also, the ICH has started wording guidelines to “inspection-ready,” meaning that it is becoming a regulatory requirement.

The TMF is the story of the clinical trial; it’s there to ensure an ongoing effective control process and provide real-time metrics of what is happening. To help you maintain that TMF, an electronic trial master file (eTMF) solution is key.

The Evolution of the eTMF

Ken Lownie, head of North American Operations for Agatha, shared the story of the evolution of the eTMF application. It’s something he talks about a lot (we even have a whitepaper that goes into the evolution in depth).

Lownie started by asking a simple question: can you maintain TMF inspection readiness with a paper-based proceed? It’s not impossible, but the manual effort you would have to perform is great. An eTMF, on the other hand, is similar to having a robot keep your child’s room clean. It’s a much easier process with the help of automation (you’ll have to listen to the replay to get the details on that analogy).

The eTMF has progressed from a simple filing cabinet to store your trial documents, Lownie explained. It’s also a Process Hub where things happen, results are obtained, documents are reviewed and approved, and quality assurance is checked. The eTMF “tracks everyone and everything,” he said.

But it’s more than a Process Hub as well. It’s also a Collaboration Hub, where the sponsor, CRO, and Sites can connect, coordinate, and communication in the trial master file environment.

A Platform for a Digital, Decentralized Trial

“Your eTMF is the platform for a digital, decentralized trial,” Lownie explained.

TMF Inspection Readiness

Here’s how it would work:

  • The sponsor tracks documents and activities, performs QA and approval workflows
  • The CRO gives their CRAs access to review documents and provide comments and feedback to Sites. In this instance, you may have multiple service providers across the globe.
  • Sites upload documents, which are then monitored by the CRO and/or sponsors and then moved into the TMF when approved.

Agatha eTMF is built on the DIA Reference Model, which is a superset of what should be in the TMF. The sponsor or CRO can then adapt the model to fit the requirements for the selected clinical trial.

Lownie also went through the list of essential TMF capabilities, including:

  1. Cloud-based, Subscription-based
  2. Based on the DIA Reference Model
  3. Pre-Populated with Expected Documents
  4. Able to Identify Missing Documents
  5. Ready to Use
  6. Easy to Use
  7. Pre-Validated
  8. Completely Compliant with Regulatory Requirements
  9. Integrates with Site Documents (ISF)
  10. Import, Export, and Archive

A critical area Lownie touched on was the requirement to maintain the TMF. According to regulations, sponsors are required to maintain the TMF for a clinical trial for 25 years. An eTMF application provided effective digital archiving and preservation to meet this requirement, ensuring:

  • Data is not corrupt or lost
  • Information is easily found
  • Files do not become obsolete.

See an eTMF in Action

The webinar closed out with a short demo of Agatha Clinical eTMF. You can watch the replay to see the demo or request your personalized demo here. Just tell us what you want to know and see, and we’ll customize a demo just for you. Or, if you just want to talk about TMF Inspection-readiness and how you can ensure your TMF is always prepared for inspectors, reach out for a conversation.

The full replay can be found here.

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