Site staff readiness and training

In conventional trials, sites traditionally serve as central locations for patient recruitment, monitoring and data collection, and regulatory compliance. In a DCT these traditional roles change, shifting some trial activities away from sites to remote settings.

Privacy & data protection

The successful and sustainable adoption of DCTs hinges on robust data privacy and protection measures. Moving trial activities outside traditional research sites significantly increases the complexity of data flows and amplifies privacy and data protection challenges, such as participant personal data being shared to third party service providers.

PI responsibilities, oversight and safety reporting