Clinical investigational plan amendments, if it becomes necessary, to so amend it, before initiation or during the course of a clinical investigation, shall be notified to the Central Licensing Authority in writing along with approval of the Ethics Committee, if available, which has granted the approval for the study. No deviations from or changes to clinical investigational plan shall be implemented without prior written approval of the Ethics Committee and the Central Licensing Authority except when it is necessary to eliminate immediate hazards to the study subject or when changes involve only logistic or administrative aspects of investigation. All such exceptions shall be immediately notified to the Ethics Committee as well as to the Central Licensing Authority within 30 days. (2) Responsibilities of Sponsor: (i) The sponsor is responsible for implementing and maintaining quality assurance system to ensure that the clinical investigation is designed, conducted, monitored, and that data is generated, documented, recorded and reported in compliance with clinical investigational plan and Good Clinical Practices (GCP) Guidelines issued by the Central Drugs Standards Control Organization, Directorate General of Health Services, Government of India and applicable rules.