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 pl ...

Introduction The introduction may contain a brief statement placing the clinical investigation in the context of the development of the investigational medical device and relating the critical features of the clinical investigation (e.g. objectives and hypotheses, target population, treatment and follow-up duration) to that development. 6. Investigational medical device and methods 6.1 Investi ...