Welcome to CAREB - Bienvenue a l'ACCER

Dear CAREB members,

To those attending the CAREB annual conference in Montreal with a particular interest in external SAE reporting.... Laurel Evans and Janet Manzo will be providing an update from the CAREB SAE Working Group on May 1 at the 11:30 to 12:15 Panel Session. We are hoping that we will have Health Canada's response in time to include in our update.

On August 21, 2009, the Board of Directors of CAREB issued a draft guidance document on the reporting of external (non-local) SAEs" for a broad, 90-day consultation period. CAREB received constructive feedback from multiple stakeholders, which the CAREB SAE working group (WG) incorporated into a revised draft guidance document entitled "Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada". In addition, the SAE WG compiled a background document, highlighting the involvement of CAREB in this issue in Canada. In anticipation of the session, the two DRAFT documents are now available (attached and posted to the CAREB website).

CAREB DRAFT Guidance - Reporting of Unanticipated Problems including AEs

CAREB DRAFT AE Guidance Background Document

Bring your questions/comments to the meeting!