ICH E6(R3) - Good Clinical Practice P9: Generate reliable results through fit-for-purpose information, systems and validated computerised systems, robust record management, secure retention of essential records and transparency through registration and results posting

What does P9 require?

The quality and quantity of information should be fit for purpose and enough to support confidence and good decisions. Systems for data capture, management and analysis and for assuring information quality should be fit for purpose, capture what the protocol requires and be proportionate to risk and data importance; computerised systems should be fit for purpose (for example through risk-based validation) with critical quality factors addressed in design or adaptation. Records, including data, should be managed so integrity and traceability are kept and personal information protected, sponsors and investigators should keep essential records secure for as long as required and made available to regulators, monitors, auditors and IRBs/IECs on request, and trials should be registered promptly in public databases with results posted, considering objective, non-promotional communication of results to participants.