Update on the CAREB Guidance on SAE reporting

To the biomedical research community in Canada,

On August 21, 2009, the Board of Directors of the Canadian Association
of Research Ethics Boards (CAREB) issued a Draft Guidance on Reporting
of External (Non-Local) SAEs to Research Ethics Boards in Canada for a
90-day consultation period. The Draft Guidance was broadly distributed
(to the research ethics community, the biomedical research community,
biomedical networks, clinical trial sponsors and Health Canada).

We received constructive feedback from multiple stakeholders including
pharmaceutical and cooperative group sponsors and research ethics boards
(REBs). We have not yet heard from Health Canada.

The CAREB SAE Working Group will review the comments and incorporate
them into a revised Guidance as appropriate. In the meantime, we are
also communicating with Health Canada to obtain their input.

CAREB is a grassroots national membership organization intended to
represent the interests of all Canadian REBs and to reflect REB
perspectives and concerns.

If you have any questions or concerns, please contact the CAREB Board of
Directors at "board@careb-accer.org" .

Best regards,

Alex Karabanow
CAREB President