Paragraph 29 Obligations as to post-authorisation safety studiesF1

the study protocol; and

the abstract of the final study report and the final study report.

all study information is handled and stored so as to allow for accurate reporting, interpretation and verification of that information;

the confidentiality of the records of the study subjects remains protected; and

the analytical dataset and statistical programmes used for generating the data included in the final study report are kept in electronic format and are available for auditing and inspection.