Cardiology Research at Columbia University Irving Medical Research Center developed this screening consent form document as an alternative to a full consent process for studies in which the anatomy plays a key part in inclusion/exclusion. This allows their team to send standard of care images and data to sponsors in order to determine eligibility before we conduct a full consent process with the patients. Typically their physicians will see patients in the clinic, send them for standard of care testing (lab work, CT, echo, etc). It isn’t until after the treating physician reviews the images, that they can determine which (if any) study the patient might be eligible for. Having the patient sign the screening consent during their clinic visit saves the patient from having to come back to the clinic to sign a study specific consent and reduces the time from the patients initial visit to the time they are treated.
Note: This consent form was not developed by MDIC, but has been shared for use by MDIC stakeholders with permission by Columbia University.