What does 3.12 require?

Noncompliance with the protocol, SOPs, GCP or regulation by an investigator, institution or sponsor staff should lead to appropriate, proportionate action to secure compliance. Where noncompliance significantly affects, or could affect, participants or result reliability, the sponsor should perform root cause analysis, implement corrective and preventive actions and confirm they work unless justified otherwise, and for serious noncompliance notify regulators and the IRB/IEC as regulation requires and the investigator as appropriate. Where significant noncompliance by an investigator, institution or provider continues despite remediation, the sponsor should consider ending their participation, promptly notify regulators and the IRB/IEC as appropriate and minimise the impact on participants and results.

ICH E6(R3) - Good Clinical Practice 3.12: Act...

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

3.1 Design trials with enough supporting safety and efficacy data, quality built in around critical to quality factors, input from interested parties and operational feasibility without unnecessary complexity or burden
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
3.13 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