What does 2.12-records require?

The investigator or institution should maintain trial records as Appendix C and regulations require and control all essential records it generates before and during the trial, retain them for the regulatory retention period or until the sponsor confirms they are no longer needed if that is later, with measures that keep them available, accessible and readable and that stop unauthorised access and accidental or early destruction, keep the sponsor informed of who is responsible for the records during retention (for example if the site closes or the investigator leaves), and make all requested trial records directly available to monitors, auditors, the IRB/IEC or regulators.

ICH E6(R3) - Good Clinical Practice 2.12-records...

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-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