Safety narratives in CSRs

According to the ICH E3 Guideline (Structure and Content of Clinical Study Reports), each study report (CSR) must contain a section on Safety (section 12). Most of the content here are listings, but section 12.3.2 requires Narratives of Deaths, Other Serious Adverse Events and Certain Other Significant Adverse Events.

A narrative is a brief textual description of the case. An interesting question is, where the content for these narratives comes from and who is supposed to to provide or write it. This could be either the Drug Safety (Pharmacovigilance) unit, or Medical Writing. Drug Safety could argue that the basic ocntent already exists as part of the CIOMS (Council for International Organizations of Medical Sciences) forms that are used for SAE reporting (reporting of Serious Adverse Events) and that have been submitted to the authorities already. On the other hand, Medical Writing could argue that these narratives are too lengthy and elaborated and not suitable for inclusion into the CSR. In addition there might be diverging data elements, such as reference dates.

A solution might be to use the clinical database to generate the CSR Safety Narratives automatically. One could develop a standard text, which is then filled with database content. This would create narratives that all have the same "look and feel", even though they might render somewhat "mechanic" texts. There are also some advantages:

• There are no more data divergence problems, since all data comes from one system. However, it should be checked whether the number of items being subject to reconciliation needs to be increased to ensure that all data being used for creating the narrative from the clinical system is consistent with the corresponding elements in the Drug Safety system.


• The narratives can be kept brief and there is no need for harvesting CIOMS forms. Those could be made available to the authority upon request.


• If the data extraction process is validated, there is no need for output validation of each narrative.


• The narratives must not be reviewed by medical experts with regard to correctness.

If any of you has experience regarding this issue, I would really appreciate your feedback.