Data management (a) Procedures used for data review, database cleaning, and issuing and resolving data queries. (b) Procedures for verification, validation and securing of electronic clinical data systems, if applicable. (c) Procedures for data retention. (d) Specified retention period. (e) Other aspects of clinical quality assurance, as appropriate. 1.9 Amendments to the clinical investigation plan Description of the procedures to amend the Clinical investigation plan. 1.10 Deviations from clinical investigation plan (a) Statement specifying that the investigator is not allowed to deviate from the clinical investigation plan, except without appropriate notifications or approvals from Ethics Committee and Central Licensing Authority, as the case may be. (b) Procedures for recording, reporting and analyzing clinical investigation plan deviations. (c) Notification requirements and time frames. (d) Corrective and preventive actions and principal investigator disqualification criteria. 1.11 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.