What does 2.3 require?

The investigator may delegate trial activities, with sponsor help in identifying service providers, but decides whether a provider is suitable, keeps ultimate responsibility and oversees delegated work in proportion to the importance of the data and the risks to participants and data reliability. Those delegated to should be suitably qualified and informed about the protocol, product and their tasks, with trial-specific training where tasks go beyond their usual training. A record of persons and parties delegated to should be kept, proportionate to the significance of the activity (not always needed for activities that are part of clinical practice), agreements with service providers documented, and monitoring, audit, regulatory inspection and IRB/IEC review allowed.

ICH E6(R3) - Good Clinical Practice 2.3: Investigators...

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
2.4 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
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