Regulatory and other references (a) List of International Standards, if any, complied with in full or in part. (b) Statement of conformity with national regulations, where appropriate. (c) List of references, if relevant. CLINICAL INVESTIGATION PLAN 1.1 General 1.1.1 Introduction This document specifies the content of a clinical investigation plan (hereinafter to be referred as CIP). If the required information is written in other documentation, for example the IB, such documentation shall be referenced in the CIP. The content of a CIP and any subsequent amendments shall include all the topics listed in this document, together with a justification for each topic if this is not self-explanatory.