Q&A 12 : Where would secondary objectives fall as a structural risk, essential or non-essential?

“Where would secondary objectives fall as a structural risk, essential or non-essential?”

IGH GCP Ref: 5.0.1 ; 5.0.2

Each objective should be evaluated in terms of it’s importance to the program and drug safety profile. It would not be accurate to state that all secondary or exploratory objectives are non-essential, but they should be questioned/challenged in terms of their necessity to the program and profile and the risk-benefit should be considered, in terms of subject protection and burden to subject and site.

Also important to note that non-essential risk can be present in the processes and data related to the primary objectives, so these should be scrutinized too, to ensure that we are doing what is necessary.

  Tammy Finnegan, COO  tammy.finnigan@tritrials.com

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