The REporting a Time-to-onset Analysis using the Individual Case Safety reports in  PharmacoVigilance (RETAICS-PV) is an international collaborative which aim at developing the first reporting recommendations for studies using a time-to-onset (TTO) analysis in databases of primarily spontaneously reported individual case safety reports (ICSR).

As part of the utilization of the individual case safety reports (ICSR) database, time-to-onset (TTO) analyses based on drug-related adverse event reports in the database is actively being performed in conjunction with disproportionality analyses.

Several reporting guidelines have been developed for observational studies. However, these guidelines are outside the scope of reporting TTO analyses. Therefore, TTO analyses are often poorly reported and interpreted.

The RETAICS-PV is to increase transparency by providing researchers with the minimum reporting requirements necessary to adequately communicate the methods and results of TTO analyses.

September 1, 2025: Start of the open-text survey on items to be included in the guideline.

June 30, 2025: Start of recruitment for working committee members.

June 18, 2025: We registered our project on the Equator-Network.

June 11, 2025: We launched the project's homepage.