What does 2.1-2.2 require?

Each investigator should be qualified to take responsibility for proper conduct of the trial and give evidence of it, be familiar with appropriate use of the investigational product as set out in the protocol, IB, product information or other sponsor material, be able to show (for example from past or current data) that the agreed number of eligible participants can be recruited in the agreed period, and have enough time, qualified staff and suitable facilities for as long as the trial is expected to run.

ICH E6(R3) - Good Clinical Practice 2.1-2.2...

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

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
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