agents, contractors and sub-contractors, and clinical investigation sites shall be open for inspection by officers of the Central Licensing Authority authorised in this behalf who may be accompanied by officers of State Licensing Authority or outside experts under these rules to verify compliance of the requirements of these rules for conduct of clinical performance evaluation; (vi) the clinical performance evaluation shall be initiated 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 such clinical performance evaluation; (vii) the Central Licensing Authority may impose or exempt any condition while granting permission in respect of specific clinical performance evaluation, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of clinical performance evaluation.