Per ICH E 8 General Considerations for Clinical Trials which of the following Per ICH Q9 Quality Risk Management which of the following are true? Group of answer choices A. Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle B. The best practice for ensuring quality is to limit quality checks to a formal audit at the end of the study C. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of the risk.are expectations for ensuring Quality by Design (QbD). Group of answer choices A. The quality by design approach to clinical research involves focusing on critical to quality factors to ensure the protection of the rights, safety, and wellbeing of study participants. B. Quality is a primary consideration in the design, planning, conduct, analysis, and reporting of clinical studies. C. Quality by design includes establishing a culture that supports open dialogue and engaging stakeholders in study design D. All of the above