Methods and Timing of Assessing, Recording, and Analyzing Safety Data Sample Clauses

Methods and Timing of Assessing, Recording, and Analyzing Safety Data. Methods and timing of assessing safety data are discussed in section 3.11. Procedures for recording safety data are discussed in section 13.1, and methods of analyses are discussed in section 9.7. Furthermore, all adverse events will be reviewed on a periodic basis (eg, scheduled safety reviews for study drug) as interim/preliminary safety databases become available (see section 7). An independent, external DSMB will oversee the safety of the patients enrolled in the study and monitor the occurrence of flare throughout the study (see section 3.6). This study may be prematurely terminated if, in the opinion of the DSMB or the sponsor, there is sufficient and reasonable cause. Written notification documenting the reason for study termination will be provided by the terminating party to all involved.