Within the PCR group, the ITR team conduct qualitative (interviews) studies and/or surveys in the context of a clinical trial to obtain feedback from clinical trial participants (patient, caregiver, investigator or study staff) on various topics i.e., understanding patients’ experience with their condition, its impacts on their lives, exploring treatment benefit, describing trial participant experiences and identifying aspects of burden from their participation. ITR can be implemented using an embedded design (e.g., ITR is defined as clinical trial activity in the clinical trial study protocol and ICF) or associated design (ITR is covered under separate protocol, separate ICF, and IRB/EC approval, with separate site recruitment and contracting).