(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, withdrawal and statistical consideration and record keeping pertaining to clinical investigation; (n) "clinical performance evaluation" means the systematic performance study of a new in vitro diagnostic medical device on a specimen collected from human participants to assess its performance; (o) "clinical research organisation" means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of clinical investigation or clinical performance evaluation;