Employees - Records
Test facility management need to ensure that a sufficient number of qualified personnel are available - for the timely and proper conduct of the study.
An organisation chart is expected to be available to demonstrate the roles and reporting relationships of personnel in the test facility.
Test facility management needs evidence that suitably capable staff have been employed, so should ensure that personnel records are maintained.
Click the image to see what records should be kept.
Test facility management should also ensure personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions for each professional and technical individual.
