Annex 4 in the draft ICH-GCP E6 (R3) is about data governance. In fact, the content of this guidance is quite similar to the requirements of FDA 21 CFR Part 11.
The data governance chapter is a guide for investigators and sponsors on how to properly manage the integrity, traceability, and security of clinical trial data to enable accurate reporting, verification, and interpretation. In ICH-GCP E6 (R2), the responsibility for data management was mainly on the sponsor, and now it has been extended to investigators. In fact, most of the requirements have been in place for some time in large pharmaceutical companies or CROs, as they already comply with FDA 21 CFR Part 11.
This will require some adaptation at the sites. In fact, it is clearly stated that computerised systems used on sites as electronic health records (EHR) should be reviewed for audit trail, validation, security, backup, etc. during site selection. And it is the responsibility of the site to ensure that all (procedures, validations, etc.) are in place for the entire duration of the trial.
It also means that for academic trials as Investigator Initiated Trials, the open-access eCRF needs to be properly validated as well as any other system used. The sponsor-investigator should also ensure that there are procedures in place for disaster recovery, helpdesk, etc. This means that site IT will need to be more involved in the design of clinical trials.
Don't hesitate to register for my webinar on 20 March at 2pm CET if you want to know what this chapter is all about.
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