Reference Safety Information (RSI) is a document containing a cumulative list of all the adverse events observed during a clinical trial. The document details the seriousness/non-seriousness of the adverse events along with the description of their nature, and frequency. The purpose of an RSI may vary from situation to situation, such as providing information about the safety profile of an Investigational Medicinal Product (IMP) to an investigator or reporting the assessments of adverse reactions. In addition, RSI can also be documented with information on safety risks or potential drug interactions.

Format of an RSI

The RSI must enlist a detailed description of every adverse event observed during clinical trials. All the adverse events are listed under body system organ class. This is followed by a description of the nature of the adverse event. After this, the seriousness of the event/severity is recorded followed by the frequency of the event.

The RSI is updated only once a year to align with the annual period of a development safety update report (DSUR). Therefore, the data of DSUR is used as supporting evidence for the RSI. Also, a substantial amendment has to be submitted in case any changes are made to the RSI.

RSI does not include safety information with respect to

  • Any adverse events or serious adverse events which are not related to IMP
  • Adverse reactions, which are not serious
  • Unexpected serious adverse reactions which can prove to be fatal and are required to be reported as suspected unexpected serious adverse reactions (SUSARs)
  • Serious adverse reactions which have been observed only once, unless they are critically related to the IMP
  • Serious adverse reactions which are expected in the products of similar therapeutic class
  • If an IMP is not supposed to cause any serious adverse reactions, then along with RSI, a statement must be mentioned stating that no serious adverse events are expected to expedite reporting of SUSARs for the IMP in the DSUR

The RSI plays an important role during clinical trials. Therefore, authoring a compliant RSI addressing all the adverse events is critical. Are you looking for assistance with respect to RSI? Reach out to an expert at sales@freyrsolutions.com.