What does 3.7-3.8 require?

The sponsor selects investigators and institutions who are qualified and show adequate resources and facilities, organises and documents any coordinating committee or coordinating investigator roles before they start, and gives prospective investigators the protocol, an up-to-date IB and enough time to review them. Before starting, the sponsor (or sponsor and investigator) should submit required applications to regulators for review, acceptance or permission, dated and identifying the protocol, and obtain the IRB/IEC's name and address, a statement that it operates under GCP and regulation, and its documented initial and later approvals or opinions and any termination or suspension.

ICH E6(R3) - Good Clinical Practice 3.7-3.8: Select...

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
3.12 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

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