Common use of ASSESSMENT OF SAFETY Clause in Contracts

ASSESSMENT OF SAFETY. Assessment of possible (serious) adverse events (AEs/SAEs) after surgery (e.g. intestinal bleeding, bowel perforation) from randomization until reaching the primary endpoint or 12 months post enterostomy closure. AEs and SAEs have to be reported in the eCRF. Serious adverse events will be reported to the Ethics Committee according to the Declaration of Helsinki.

ASSESSMENT OF SAFETY. ‌ Assessment of possible (serious) adverse events (AEs/SAEs) after surgery (e.g. intestinal bleeding, bowel perforation) from randomization until reaching the primary endpoint or 12 months post enterostomy closure. AEs and SAEs have to be reported in the eCRF. Serious adverse events will be reported to the Ethics Committee according to the Declaration of Helsinki.