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Clarification of ownership of IRT data from clinical trials: site vs. sponsor

Stakeholders across the industry need to discuss ownership to ensure effective implementation.

Recently, the MHRA posted: “Is your eSystem really an eCRF? (Https://bit.ly/3CHzVMw), which identified an equivalence between the IRT and the eCRF with regard to the ownership of the data by the survey site. While reading this blog, an experience I had previously as a trial sponsor came to mind. During an MHRA inspection, clarity of perspective on the ownership of IRT data was communicated. The inspectors ensured that we (the sponsor) were not as integrated into the data modification process as usual (i.e. site requests change, sponsor approves). The message was that the investigation site was responsible for the validity of its IRT data and that sponsors needed to understand the implications.

Since entering the industry in the mid-90s, my view has been that IRT data is viewed more as transactional for the purposes of drug randomization and allocation. It is not the same as eCRF data and should not be treated as such. But my point of view changed somewhat after this inspection and became stronger after reading the MHRA blog.

In the blog, the MHRA reminds us of what a CRF is, defined as ICH GCP E6 R2 (2016), 1.11: a printed, optical or electronic document designed to record all the information required by the protocol to be declared to the promoter at each test. matter. So basically any system designed to record protocol data and report to a sponsor on each trial.

They bring home some key points, including:

  • “… whatever name you give your system, if it records the information required by the protocol and provides it to the sponsor, it is also a CRF and must have the required functionality of a eCRF. “
  • “The functionality of these systems should allow data modifications and authorizations by the investigator with a clear audit trail to verify the integrity of the assay data and explain why the data was modified. “
  • “In accordance with the ICH GCP, these data belong to the investigator and must therefore be available for and under the control of the investigator (and not under the direct control of the sponsor). “

So between my inspection experience and the MHRA blog, it’s clear to me that regulators are taking a closer look at how IRT data meets requirements to ensure data integrity, including data ownership. . It is equally clear that the industry was not ready to act and will benefit from best practices in light of the implications.

Since then, I have spoken with different trial stakeholders (sponsors, CROs, solution providers) and can suggest several questions that need to be addressed as best practices are established. The overriding question is, since the IRT data is owned by the investigation site, does the sponsor currently have too much influence over changes to the data?

Additional questions focused on what happens at the end of a study include:

  • What data should be included?
    • Data change? Audit trails? Who made each change?
  • What process changes need to happen from a sponsor, supplier and site perspective?
    • Should data be transmitted directly to sites rather than through sponsors to ensure data integrity?
    • Will sites have to go through a culture shift to see data as more than just transactional?
  • How should the data be transferred / what format?
    • Shouldn’t we be using modern methodologies for archiving and delivering data?
  • How will the investigation sites react to this clarity in the management of IRT data?
    • What will investigation sites do with the data?

A change in the landscape regarding clarity around who owns and is responsible for IRT data is ripe for industry discussion. As we come to a defined level of what is expected and when, the challenge will be to examine this clarity in expectations and understand it not only as a change for trial sponsors, but also as a change that affects across the industry, requiring input from different industry stakeholders to ensure effective implementation.

Craig Mooney, Vice-President, Scientific Services eTech-Enabled, Calyx