60. Conditions for permission to conduct of clinical performance evaluation.
- After grant of permission referred to in sub-rule (5) of rule 59, the following conditions shall be complied with by the applicant,-(i)clinical performance evaluation shall be conducted in accordance with the approved clinical performance evaluation plan and Good Clinical Practices Guidelines;(ii)clinical performance evaluation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee;(iii)clinical performance evaluation shall be registered with the Clinical Trial Registry of India before enrolling the first participant for such clinical performance evaluation;(iv)annual status report of each clinical performance evaluation, 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 performance evaluation, the detailed reasons for the same shall be communicated to the Central Licensing Authority within thirty days of the date of termination;(v)the laboratories or other institutions taking part in the evaluation study or 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 authorized 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.
