Paragraph 22 Conduct of the safety study

A unique identification should be given to each safety study. All items concerning this safety study should carry this identification.

The safety study should be conducted in accordance with the study plan.

All data generated during the conduct of the safety study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated.

Any change in the raw data should be made so as not to obscure the previous entry, and should indicate the reason, if necessary, for change and should be identified by date and signed by the individual making the change.

Data generated as a direct computer input should be identified at the time of data input by the individual responsible for direct data entries. Corrections should be entered separately with the reason for the change, the date and the identity of the individual making the change.