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ROI CalculatorClinical Quality Assurance (CQA) is the independent function that ensures clinical trials are planned, conducted, recorded, and reported in compliance with regulations and Good Clinical Practice (GCP).
FDA regulations 21 CFR Parts 50, 54, 56, and 312 and ICH GCP E6(R2/R3) require sponsors to implement quality systems, perform audits, manage deviations, and protect subject safety and data integrity.
Why it is important: Because a weak CQA can lead to invalid data errors, inspection findings, delayed approvals, trial rejection, and much more.
