In CIHR-funded trials it's very clear. The requirement for registration and reporting of adverse effects is mandatory. It's part of the contract that we sign with the investigator when we give out the grant. Should the terms of the contract not be respected, they would be in breach of the contract, actually. They would be in breach of the TCPS's tri-council policies on ethics for trials, in which case that would come under the secretariat on ethics, which would recommend—would recommend to me, actually—a number of sanctions, the first one usually being non-eligibility for future funding at CIHR.
On November 20th, 2014. See this statement in context.