(1) "clinical investigation" means the systematic study of an investigational 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; (p) "conformity assessment" means the systematic examination of evidence generated and procedures undertaken, by the manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore conforms to the essential principles of safety and performance for medical devices; (q) "controlling officer" means the officer designated under rule 10; (r) "custom made medical device" means a medical device made specifically in accordance with a written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility for the sole use of a particular patient, but does not include a mass production of such device; (s) "Ethics Committee" means the committee referred to in rule 50; (t) "Form" means Forms specified in Appendix to these rules; (u) "Good Clinical Practices Guidelines" means Good Clinical Practices Guidelines issued by Central Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India;