What does 2.9 require?

When a participant stops the product, withdraws, is discontinued or completes, the investigator should act as the protocol and its related documents direct, which for early leavers may include steps to avoid losing data already collected (as regulation allows), since lost data can bias results. Participants need not give a reason for withdrawing, but the investigator should reasonably try to learn the reason while fully respecting their rights, may discuss concerns and the value of continuing without unduly influencing or interfering with the decision, and should, where relevant and wanted, tell participants about results and their treatment once the sponsor provides it after unblinding.

ICH E6(R3) - Good Clinical Practice 2.9: When...

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
2.4 Before starting, hold documented, dated IRB/IEC approval of the protocol, consent materials, recruitment procedures and participant information; supply the current IB, participant information updates and status summaries; and report changes affecting conduct or increasing risk 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