B.9.1 Specification of safety parameters.
B.9.2 The methods, extent and timing for recording and assessing safety parameters. Where any trial-related committees (e.g., IDMC) are utilised for the purpose of assessing safety data, procedures, timing and activities should be described in the protocol or a separate document.
B.9.3 Procedures for obtaining reports of and for recording and reporting adverse events.
B.9.4 The type and duration of the follow-up of participants after adverse events and other events such as pregnancies.