IEC and data privacy are covered in the protocol.
Good point about (S)AEs related to other eventual medications the patients may be taking. This would be required by standard practice, but the requirement could be reinforced in the protocol.
To provide the missing clarification: This Natural History study is for a rare genetic disease. There is no recommended / required change to standard of care; all "interventions" are for diagnostic purposes (blood draws, ultrasound, physiotherapy tests / measurements, etc.), to develop a clearer picture of the disease progression. There is no treatment intervention, only physical intervention (as described above) and psychological intervention (completion of questionnaires, e.g. QoL). The regulatory definitions are unclear in this area - hence the study team's questions on requirements. The plan is to follow GCP as/where applicable/possible, but in the area of safety reporting, more guidance would be appreciated. Hence, my question