What does 2.4 require?

Depending on regulation, the investigator, the institution or the sponsor makes submissions. The investigator or institution should have documented, dated IRB/IEC approval or favourable opinion of the protocol, consent materials, recruitment procedures such as advertisements and other participant information before starting, provide a current IB or basic product information (and updated versions), provide updates to participant information as the trial progresses, submit trial status summaries as local rules require or on request, and promptly tell the IRB/IEC (and the institution where relevant) about changes that significantly affect conduct or increase risk to participants.

ICH E6(R3) - Good Clinical Practice 2.4: Before...

Other controls in Annex 1 section 2: investigator – ICH E6(R3) - Good Clinical Practice

2.1-2.2 Investigators are qualified by education, training and experience, know the investigational product, can show realistic recruitment potential and have enough time, staff and facilities
2.10-2.11 Manage investigational product at the site (accountability, storage, use per protocol, participant instruction, direct-to-participant delivery safeguards) under investigator oversight, follow randomisation, break the blind only per protocol and document any premature unblinding
2.12-records Maintain and control the investigator's essential records per Appendix C, retain them for the required period or until the sponsor says they are no longer needed (whichever is longer), protect them, name the responsible custodian and provide direct access on request
2.12-source Ensure integrity of site data: ALCOA-quality source records with traceable changes, a defined source and capture plan, timely review of data including external data, correct use of sponsor tools, accurate and consistent reported data endorsed at milestones, privacy protection and unambiguous participant codes
2.12-systems For site-deployed systems protect data from unauthorised access, alteration or loss, give secure attributable access, tell the sponsor of access changes for its systems, meet section 4 for trial-specific systems, keep traceability and training for participant devices and report significant system incidents
2.13 On completion inform the institution, give the IRB/IEC a summary of the outcome and send regulators any required reports
2.3 Investigators delegate only to qualified, informed people and parties, keep a proportionate delegation record, document service provider agreements, retain responsibility and oversight, and permit monitoring, audit, inspection and IRB/IEC review
2.5 Sign the protocol or agreement, comply with the protocol, GCP and regulation, document every deviation, explain and prevent recurrence of important ones, deviate only to remove immediate hazards and report such deviations promptly

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