Dear EMPOWER Collaborators,
We are pleased to announce that the EMPOWER Protocol Version 2.0 has been approved!
Revisions to the protocol reflect the feedback we have received from several of our sites, and address various recruitment challenges. The following is a summary of the major changes that we anticipate will increase recruitment opportunities and simplify the workload for sites:
- An expansion and clarification of the inclusion/exclusion criteria to be less restrictive and more inclusive,
- Details regarding the purpose, process and timeline for the conduct and reading of ECGs; and
- Clarification of study procedures and requirements for the conduct of the trial.
The EMPOWER Coordinating Centre (CC) has emailed each site a copy of the amended version of the protocol (Version 2.0), as well as other required documents, for review by their Qualified/Site Investigator prior to submission to their local REB/IRB. A revised version of the Manual of Procedures (MOP) will be sent to sites individually as approval is obtained.
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.
Thank you for all of your hard work, continuous effort and ongoing support of the EMPOWER study.
Keep up the great work !