Q&A 30 : Is the task of quality management now implicit as part of delegated study activities mgmt. to a CRO?

“Is the task of quality management now implicit as part of delegated study activities mgmt. to a CRO?”

ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2

Yes, as more regulatory authorities adopt R2, the expectation will be there that this process is accounted for in the QMS of all vendors involved in trial conduct, and it may be conducted independently or in conjunction with the sponsor (I would advocate it is a conducted as a joint activity). The sponsor is ultimately responsible but as the representative, your processes should cover this.

Interestingly, in a presentation at the Global QA meeting in Edinburgh, the EMA representative, Sophia Mylona, publicly stated that the EMA would expect sponsors (and their representatives) to implement R2 principles retroactively to ongoing studies, where is made sense and was practicable, I would suggest this means, if you have protocol amendments, the Q(R)M processes should be applied, but Sophia also indicated this could apply to monitoring findings e.g. applying root cause analysis methods, assessing overall risk to other sites and implementing changes to monitoring plans as necessary. So if you are working in areas under EMA jurisdiction or the study data may be submitted to the EMA, this is something to be thinking about as it is now in effect as of 14 Jun 2017.

    Tammy Finnegan, COO tammy.finnigan@tritrials.com

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