Device accountability Description of the procedures for the accountability of investigational medical devices should be maintained. 1.12 Statements of compliance Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 186 of 248 (a) Statement specifying that the clinical investigation shall be conducted in accordance with the ethical principles as prescribed in Good Clinical Practices. (b) Statement specifying that the clinical investigation shall not begin until the required approval from the Ethics Committee. (c) Statement specifying that any additional requirements imposed by the Ethics Committee or Central Licensing Authority shall be followed, if appropriate. (d) Statement specifying the type of insurance that shall be provided for subjects, if appropriate. 1.13 Informed consent process (a) Description of the general process for obtaining informed consent, including the process for providing subjects with new information, as needed. (b) Description of the informed consent process in circumstances where the subject is unable to give it; in the case of emergency treatment, process should be clearly specified.