The role ‘drug safety officer’ was made to keep a clear view of the CRF, without letting the user make changes. This role does not differ much from the auditor, except that he does not have access to Patient self-service, and is allowed to export.
A drug safety officer can for example:
- Look at patient details.
- Look at CRF information.
- Look at commentary and queries.
- Export data.
A drug safety officer cannot:
- Add, change or remove any kind of data.
- Change the settings of the application or study.
- Look at the patient self-service