The medical advisor will conduct or support the development of all required documents within a clinical trial (e.g. protocol, informed consent) and search for approval by the sponsor.

The safety officer is responsible for the review of all study related documents and the detailed safety review of all incoming CRFs within 24 hours after receipt. Previously not recognised or not appropriately reported Serious Adverse Events or Unexpected Adverse Events may be notified to the sponsor within 24 hours and documented on an initial SAE report form.

If data are missing, incomplete or inconsistent, the safety officer may contact the investigator directly for clarification of those issues and document this in an SAE follow-up report.

On request, detailed SAE case narratives may be prepared to document relevant safety issues for responsible authorities (e.g. within the safety reports or within the final study report). An SAE reconciliation process is recommended in order to achieve consistency between clinical and safety database.

The service may also include Safety Reports and preparation of PSURs.