Q. How will the core lab information be transferred?
A. There will only be one essential core lab:
• Echo core lab: information will either be transferred using MEDCON or sent on an anonymised CD. For specific details on parameters, please contact the CTU. An SOP is in development, however please store images on site for the time being.
Q. What will happen to the echo sent to the core lab?
A. The secondary endpoint of LV function will be determined by the echos sent to the core lab.
Q. What are the other core labs?
A. These will be optional for sites that wish to participate in them.
• ECG core lab: the best way to store ECGs would be to make a photocopy and keep with the CRF. An SOP is in development which will describe the transfer procedure.
• Viability core labs: An SOP is in development which will describe the transfer of DSE/MRI data, until then this data should be stored on site.
• ICD core lab: this is being run by Jonathan Behar (email@example.com). If your site has expressed interest in contributing to the ICD core lab, Jonathan will be in contact shortly after the first patient has been recruited.