Medidata Blog

Don’t Overlook This ICH E6 (R2) Challenge

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With the introduction of ICH E6 (R2), our industry has been highly focused on the challenge of data integrity. For the first time, ICH E6 places greater responsibility on sponsors, CROs and sites to develop systematic, prioritized, risk-based approaches to monitoring clinical trials.

While this new guidance has created a much needed sense of urgency to define a risk-based monitoring approach to clinical trials, there is one critical area of monitoring that is easy to overlook—essential documents.

According to the R2 addendum, responsibility of essential documents and source document maintenance is now allocated to the sponsor and investigator. The sponsor, or other owners of the data, should retain all sponsor-specific essential documents pertaining to the trial. Additionally, the sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including those subcontracted to another party by the sponsor’s CROs.

These new essential documentation responsibilities, may seem like an obvious modern day capability for managing a clinical trial, but without the proper processes and technology, sponsors could find themselves struggling to maintain compliance, and in the worst case, with critical findings.

This challenge was evident following in the MHRA 2015-2016 GCP Inspection Metrics Report, which showed that deficiencies in essential documents had the second-highest number of critical findings (deficiencies in monitoring had the highest). The essential document findings were due to documents that were missing, incomplete, and not contemporaneous.

As sponsors and partners develop their strategies to maintain ICH compliance, it is essential to incorporate an approach for handling these additional essential documents and trial oversight responsibilities. This approach should be tied to how a sponsors manages the Trial Master File, which should be an approach that ensures TMF is complete and contemporaneous at all times.

Sponsors who have complete ownership of their TMF and the technology and processes in place to maintain oversight—even if a CRO is helping them manage their trial—will be better positioned to maintain ICH compliance.

Jacob Angevine