Awareness : Newsletter Articles

Clinical Research Participant Enrollment and Tracking In Velos

All human participants (inpatient and outpatient) enrolled in clinical research protocols conducted at the University of Miami Miller School of Medicine (including any University of Miami facility, all affiliated and satellite locations as well as at any Jackson Health Systems (JHS) facility) must be registered in the Velos clinical trial management system, if the clinical research protocol meets any of the following criteria:

  • The clinical research protocol involves testing a drug, device or biologic; The clinical research protocol involves a pharmacovigilance study;
  • The clinical research proposal involves the study of an interventional or surgical procedure;
  • The clinical research protocol involves clinic visits or conducting procedures, lab tests and/or medical interventions on a research subject billed through a commercial laboratory.

Research protocols not meeting the above criteria:

  • Research protocols limited to the following activities are not required to be registered in Velos; however, these must be registered in a university-recognized electronic system/database that is compliant with HIPAA and electronic security regulations.

    For all studies monitored in Velos, each participant should be entered within 48 hours of obtaining informed consent.  The de-enrollment status of each participant should also be entered within 48 hours of study withdrawal or the completion of all in-person study visits.

    Please refer to the Clinical Research Participant Enrollment and Tracking Policy for the policy and procedures that should be followed.