Study Selection

How Does RCQA Select Studies to be Reviewed?

RCQA creates an annual Quality Review Plan which lists the studies selected for routine reviews during the coming year. Studies are selected using a risk-based approach based on the following criteria, which include, but are not limited to:

  •   Investigators who are holding an IND or IDE
  •   Expected level of risks to subjects/vulnerable populations
  •   Studies with a complex study design/protocol
  •   Federally-funded studies
  •   Investigators who are first time Principal Investigators
  •   Investigators that have not been previously audited
  •   Investigators with a history of non-compliance
  •   Investigators who received a Form FDA 483
  •   Investigator-initiated studies
  •   Therapeutic areas/departments/divisions not previously audited or not audited within the last 3 years
  •   Investigators storing and dispensing investigational product
  •   Investigators working outside their area of specialty
  •   Investigators with a high number of studies
  •   Social-behavioral studies
  •   Studies affected by revisions to regulations, University policy or procedure