DIN EN ISO 14155-2:2009-11

This standard is the second part of EN ISO 14155 ""Clinical investigation of medical devices for human subjects"", and should be read in conjunction with that standard. The standard is intended to assist manufacturers, sponsors, monitors and clinical investigators in the design and conduct of clinical investigations. It is also intended 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.