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Maintaining compliance with new ICH monitoring guidelines

In late 2016, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued revised guidance (E6, R2) concerning sponsors’ responsibilities with respect to trial oversight.

The guidance makes it clear that sponsors must ensure oversight of any trial-related duties carried out on their behalf, and that includes the treatment of source data.

It must be “attributable, legible, contemporaneous, original, accurate and complete1,” with changes traceable.

This revised guidance has prompted the need for sponsors to be empowered to create their own audit trail reports within Interactive Response Technology(IRT) systems.

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