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ACRP-MDP: ICH and ISO 14155-Referenced Medical Device Trial Conduct

ACRP-MDP · Work through your exam, one topic at a time.

All guide sections

ICH and ISO 14155-Referenced Medical Device Trial Conduct

The framework

ISO 14155 (Good Clinical Practice for clinical investigations of medical devices) is the backbone, harmonized with ICH E6 GCP principles. Know that ISO 14155 addresses the sponsor, monitor, investigator, and ethics committee roles, plus the CIP, informed consent, and documentation. ICH E6 supplies overarching GCP principles (ethics, data quality, traceability). Expect questions testing which party owns which obligation.

Core conduct concepts

  • Risk-based monitoring: monitoring intensity proportionate to risk; on-site and centralized components.
  • Source documents and ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
  • Deviation vs. violation: a deviation is an unintended departure; a violation is an intentional or gross departure. Both require documentation; violations escalate.
  • Unanticipated serious adverse device effect (USADE) and the serious adverse device effect (SADE) definitions-know them cold.
  • Vulnerable populations and the additional safeguards for consent.
  • Investigational device traceability from manufacture to subject.

Traps and a rule of thumb

A frequent trap: assuming the monitor "ensures" compliance. The monitor verifies; the investigator remains responsible for conduct at the site, and the sponsor for overall oversight. Another trap: treating all adverse events as reportable to the ethics committee-only certain events (e.g., USADEs, related serious events) trigger expedited reporting per the CIP.

Rule of thumb for reporting: related + serious + unexpected = expedited. If any element is missing, timelines differ. Always defer to the CIP, which may be stricter than baseline regulation.

Worked example

A subject experiences a serious adverse event that the investigator judges possibly related to the device, and it was not anticipated in the CIP. This is a USADE and requires expedited reporting to the sponsor and ethics committee within the timelines the CIP specifies. Document in source, reconcile the CRF, and preserve device accountability records.