ICH E6(R3) - Good Clinical Practice C: Manage essential records: identify which are essential by risk and relevance, keep them identifiable, version controlled and approved, hold them in TMF and ISF repositories with a location record, file them promptly, retain them complete, readable and directly accessible with traceable changes, use certified copies, share appropriately and keep them for the required period

What does C require?

Essential records let the investigator's and sponsor's GCP and regulatory compliance and the reliability of results be evaluated, support oversight and monitoring, and are used in audits and inspections; which records are essential depends on design, conduct, risk-proportionate approaches and relevance. Records should be identifiable, version controlled where appropriate and show authors, reviewers, approvers, dates and signatures where needed; arrangements should cover access and retention for records kept by service providers; records should be kept in or referenced from sponsor and investigator repositories (trial master file and investigator site file), with a record of where all essential records, including source, are located and storage systems that support identification, version history, search and retrieval; filing should be timely, with some records in place before the trial starts; records should stay complete, readable and readily available for direct access by regulators, monitors and auditors, with traceable alterations; originals are generally retained by whoever generated them, each party keeps its own records at the end (including copies obtained, for example SUSAR reports via a sponsor portal); copies replacing originals must meet certified copy requirements; sharing should respect blinding and data protection; and the appendix tables list the records typically expected and who holds them.