Dear EMPOWER Collaborators,
Please remember to submit the amended EMPOWER Protocol Version 2.0 to your local ethics committee. For sites that are not yet active, also include the revised Informed Consent Form Version 2.0.
Once approval is obtained, forward a copy to the EMPOWER CC in order to have the CTSI submitted to Health Canada and to receive the revised Manual of Procedures and study tools.
NOTE: Sites must continue to recruit study participants and conduct the trial according to Protocol Version 1.2 until ethics approval has been received for Protocol Version 2.0, training on the new protocol version has been completed, and the CTSI has been submitted to Health Canada by the EMPOWER CC.
Thank you for all of your hard work, continuous effort and ongoing support of the EMPOWER study.
Keep up the great work!