BS EN ISO 14155-2:2009

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects. Clinical investigation plans

This standard is the second part of BS EN ISO 14155 Clinical investigation of medical devices for human subjects, and should be read in conjunction with that standard.

Part 2 of BS EN ISO 14155 is intended to assist manufacturers, sponsors, monitors and clinical investigators in the design and conduct of clinical investigations. It is also written to assist regulatory bodies and ethics committees in their roles of reviewing Clinical Investigation Plans (CIP). The CIP is a framework within which appropriate experience, insight, judgement, qualification and education need to be applied. The scientific rigour of a CIP can be verified and possibly improved by an independent review of the CIP.

BS EN ISO 14155-2 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.

BS EN ISO 14155-2 does not apply to in vitro diagnostic medical devices.

Contents of BS EN ISO 14155-2 include:

• Scope
• Normative references
• Terms and definitions
• Requirements
• Clinical Investigation Plan (CIP)
• General information
• Identification of the clinical investigation plan
• Clinical investigators, principal clinical investigator, co-ordinating clinical investigator, investigation centres/site(s)
• Sponsor
• Monitoring arrangements
• Data and quality management
• An overall synopsis of the clinical investigation
• Approval and agreement to the clinical investigation plan
• Identification and description of the medical device to be investigated
• Preliminary investigations and justification of the study
• Literature review
• Previous clinical experience
• Device risk analysis and risk assessment
• Objectives of the clinical investigation
• Design of the clinical investigation
• Statistical considerations
• Deviations from the clinical investigation plan
• Amendments to the clinical investigation plan
• Adverse events and adverse device effects
• Early termination or suspension of the investigation
• Publication policy
• Case Report Forms
• Bibliography

BS EN ISO 14155-2:2009 replaces BS EN ISO 14155-2:2003 which has been withdrawn.