Table 1 Domains and their attributed risk elements

Participant Safety and Rights

Informed consent

AE/SAE reporting and documentation

Inclusion/exclusion

Overall Study Management

Recruitment

Retention

Study procedures and endpoint assessment (e.g. bio sampling, imaging quality)

Participant schedule (e.g. timeframe of visits)

AE/SAE management

Device/ Medication Management

Administration

Accountability/ storage

Study Data

Data quality – completeness, consistency, timeliness

Documentation/ storage