What does 2.12-systems require?

For systems the investigator or institution uses to hold trial data, data should be shielded from unauthorised access, disclosure, spread or alteration, and from improper destruction or accidental loss. The site should give appropriate individuals secure, attributable access to its own systems, tell the sponsor when access to sponsor systems must change or be revoked, apply the section 4 computerised system requirements to systems it deploys specifically for trials in proportion to risk, keep traceability of data collection equipment given to participants and train participants in its use, and report to the sponsor (and IRB/IEC where applicable) incidents that may significantly or persistently affect trial data or system security.

ICH E6(R3) - Good Clinical Practice 2.12-systems: For...

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
2.13 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