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.