Raw data - Changes to Raw Data
Good Laboratory Practice also provides clear instructions on how to amend raw data. Rollover the image to find out more:
This makes changes traceable - informing the reader who made the change, when and why they made it.
Because of the increasing use of computers for data collection, the principle is restated for computerised data capture. Click here to find out more
Data generated as a direct computer input should be identified at the time of data input by the individual responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example by the use of timed and dated (electronic) signatures. Reason for changes should be given.
