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Alert Level 2 update

Usually, to resume a study after a temporary halt requires that an amendment is first submitted for review by the HDEC. For studies now seeking to resume after the government-mandated lockdown, this is not necessary as long as those studies will be resuming according to the previously approved protocol.

If the protocol has been amended in any way, including so as to mitigate risk of COVID-19 infection, then it should be submitted as an amendment. All studies should note the period of suspension and the date at which the study resumed in their next annual progress report.