Good clinical practice and trial quality

This branch covers the standard a clinical trial is conducted to and the quality its conduct is held to, and its parts divide by where that quality is held: in the standard itself, in the duties ICH E6(R3) gives each party to a trial, in the quality system across a sponsor's clinical development, and in the limits a sponsor sets on one trial's conduct. It leaves the ethics that justify research on people and the ethics review a study goes through to research ethics and ethics review, quality designed into a trial's protocol to clinical study protocols, the monitoring plan and audit of a trial to monitoring, audit and their reports, participants' personal data to data protection in clinical research, and what a sponsor must make public about a trial to transparency and disclosure.

• Good clinical practice as a standard — what the standard is for and asks at each stage of a trial, what the ICH guideline covers and how it is built, its principles as one set and applied to new designs and technologies, its origins and editions, where it is legally binding, and why a writer is inside its scope
• Roles, responsibilities and oversight in a clinical trial — what ICH E6(R3) makes the ethics committee, the investigator and the sponsor each answerable for, where responsibility stays when work is delegated, and the agreements, sponsor quality management and oversight, and action on noncompliance that hold the duties in place
• Quality by design across clinical development — what quality by design rests on, how far the industry's practice of testing quality in afterwards stood from it, and the quality system a sponsor's whole clinical development is to move to
• Quality tolerance limits — what a limit is, where the method comes from and why regulators asked for it, what ICH E6 asks, what limits are set on and how, what measuring quality buys, which breaches section 9.6 of the clinical study report summarises, the root cause analysis behind that summary and how the report handles fraud and misconduct, the limits across a submission, and how widely they are used