SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 1 Topic 1 Discussion
CCRP Exam Topic 1 Question 1 Discussion:
Question #: 1
Topic #: 1
In accordance with the ICH GCP Guideline, prior to initiating a trial, which of the following should define, establish, and allocate all trial-related duties and functions?
ICH E6(R2) 5.2.1:“The sponsor is responsible for implementing and maintaining quality assurance and quality control systems… including allocation of trial-related duties.”
Although tasks may be delegated to CROs or site staff, accountability remains with thesponsor.
[References:ICH E6(R2), §5.2.1., ]
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