2023-08-05T04:54:18
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
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