Introduction The introduction may contain a brief statement placing the clinical investigation in the context of the development of the investigational medical device and relating the critical features of the clinical investigation (e.g. objectives and hypotheses, target population, treatment and follow-up duration) to that development. 6. Investigational medical device and methods 6.1 Investi ...

ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs in certain situation where, the approval of a new drug may be based on the clinical data generated considering surrogate end-point rather than using standard outcome measures such as survival or disease progression which are reasonably likely to predict clinical benefit, or a clinical end point. 8. Surrogate ...