What does 3.1 require?

When planning, the sponsor should ensure enough safety and efficacy data (nonclinical, clinical or real-world) support human exposure by the planned route, dose, duration and population; build quality into the design by identifying critical to quality factors and managing risks to them; consider input from interested parties such as health care professionals and patients for development plans, protocols, consent materials and other participant-facing information (per ICH E8(R1)); and make every aspect operationally feasible, with fit-for-purpose, clear, concise, consistent protocols, data tools and documents and no unnecessary procedures, data or burden.

ICH E6(R3) - Good Clinical Practice 3.1: Design trials...

Other controls in Annex 1 section 3: sponsor – ICH E6(R3) - Good Clinical Practice

3.10 Run a proportionate, risk-based quality management system with quality by design, identifying, evaluating, controlling (including pre-specified acceptable ranges such as quality tolerance limits), communicating, reviewing and reporting risks to critical to quality factors
3.11-QA Maintain QA and QC processes and procedures; apply risk-based QA to find causes of serious noncompliance; and run independent, qualified, documented, risk-proportionate audits under written procedures, protecting audit reports and providing audit certificates when required
3.11-activities Carry out monitoring activities across the life cycle (communication and deviation follow-up, site selection to close-out checks, investigational product checks and data checks) and report them with findings, actions and follow-up escalated and recorded
3.11-monitoring Apply risk-based QC to data handling and monitor by independent, qualified people using a risk-based mix of site (on-site or remote) and centralised monitoring set out in a tailored monitoring plan that also covers critical processes outside sites
3.12 Act proportionately on noncompliance, perform root cause analysis and CAPA for significant noncompliance, notify regulators and IRB/IEC of serious noncompliance, and consider ending persistently noncompliant investigators or providers
3.13 Evaluate product safety continuously: aggregate and review safety information promptly, communicate relevant new information, submit safety updates and periodic reports, expedite SUSAR reporting against the reference safety information, report urgent issues without undue delay, agree alternative arrangements and act on immediate hazards
3.14 Provide insurance or indemnity where required, address treatment costs for trial-related injury, and compensate participants as regulation requires
3.15-info-mfg Develop and update the IB (or identify basic product information), characterise and manufacture investigational products to GMP with blinding-protective coding and compliant labels, set storage and handling conditions, package against deterioration, run blinding and emergency unblinding mechanisms and have data on significant formulation changes

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All ICH E6(R3) - Good Clinical Practice controls