Analysis Component: Reporting Event

[ASL-rmarshall]

In the ARS, a "Reporting Event" is defined as a set of analyses performed to be a defined reporting requirement. There may be multiple reporting events for any given study.

Different reporting events:

• May have different purposes, for example:
  • Reporting events related to the primary purpose of the study (addressing the study objectives) – such as CSR and interim analyses – will be based on the objectives and estimands defined for the study.
  • There are other reporting events that have different purposes – e.g. PSUR, IDMC. How are the analyses related to these reporting events going to be identified / defined?
• May be scheduled at different timepoints – e.g.:
  • Main analysis occurs when the last subject has reached a defined timepoint.
  • Interim analysis when there has been a defined number of occurrences of a specific event within the subject population.
  • Safety report after each regular defined interval.
• May be for a specific subset/cohort of subjects