(1) "clinical investigation" means the systematic study of an investigation medical device in or on human participants to assess its safety, performance or effectiveness; (m) "clinical investigation plan" means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, w ...

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 ...