Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 113

Maintain and archive records (evidence of trial conduct). Maintain records that demonstrate the conduct of the trial. Archive records so that they are retrievable and for the duration required by applicable regulations. The investigator will have access to trial data at all times. (ICH E6(R2) 4.9 Records and Reports, 5.5 Trial Management, Data Handling, and Record Keeping, Chapter 29 Essential Documents).