A study-specific AE Reporting plan should describe which AEs will be reported. AEs may be described in a very specific list that relates to the research. For other projects it may be more appropriate to describe the AEs in a general, rather than a specific way.
Make sure the AE Reporting is explicit in stating that any AEs with a causal relation to the research will be reported and adopt the timing on the IRBMED Standard Timetable for those AEs.
It is often helpful to also indicate AEs or types of AEs that will not be reported. For example, designate predictable events for the population being studied that are not attributable to the research as events that will not be reported as AEs, even if the data is collected for study purposes (e.g. death in a elderly population with a history of stroke and diabetes; incarceration in a longitudinal study of drug abusers).
Separate aspects of the AE reporting plan into categories when appropriate (e.g. separate descriptions or tables for different cohorts). Designate what will and will not be reported using terminology as general or as specific as is appropriate.
The AE reporting plan may be submitted as a standalone document, as part of a data and safety monitoring plan (DSMP), or as part of a protocol.