- After grant of permission referred to in rule 52, the following conditions shall be complied with by the applicant, namely:-(i)clinical investigation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee;(ii)clinical investigation shall be conducted in accordance with the approved clinical investigation plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organization and provisions of the Seventh Schedule;(iii)clinical investigation shall be registered with the Clinical Trial Registry of India before enrolling the first participant for such clinical investigation;(iv)annual status report of each clinical investigation, as to whether it is ongoing, completed or terminated, shall be submitted to the Central Licensing Authority by the sponsor, and, in case of termination of any clinical investigation, the detailed reasons for the same shall be communicated to the Central Licensing Authority within thirty days of such termination;(v)information about any report of suspected unexpected serious adverse event occurring during clinical investigation on the subject shall, after due analysis, be submitted by the sponsor to the Central Licensing Authority within fourteen days of the knowledge of its occurrence as specified in the Seventh Schedule and in compliance with the procedure specified in these rules;(vi)in case of an injury or death during clinical investigation of a subject of a clinical investigation, the applicant shall provide complete medical management or compensation in accordance with these rules;(vii)the premises of the sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical investigation sites shall be open for inspection by officers of the Central Licensing Authority who may be accompanied by officers of the State Licensing Authority or outside experts, to verify compliance of the requirements of these rules for conduct of clinical investigation;(viii)the clinical investigation shall be initiated by enrolling first participant within a period of one year from the date of grant of permission, failing which prior permission from the Central Licensing Authority shall be required to initiate clinical investigation;(ix)the Central Licensing Authority may impose or exempt any condition while granting permission in respect of specific clinical investigations, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of clinical investigation.
