According to CTTI guidance, when should planning for decentralized elements begin?
Answer
During the protocol development stage.
The CTTI emphasizes that planning for decentralized elements must commence early, specifically during the protocol development stage, to ensure all logistical and technological requirements are integrated from the outset.
Related Questions
What is the primary shift defining decentralized clinical trials (DCTs)?What characterizes a hybrid decentralized clinical trial model?Which technologies are paramount for remote data capture in DCTs?Besides shipping investigational product, what else do Direct-to-Patient (DtP) services coordinate?What critical enabling factor ensures a DCT is more than just disconnected digital tasks?How does the workload for site staff primarily shift in a decentralized structure?What aptitude do successful site personnel need beyond traditional clinical research management in a DCT?How do decentralized trials impact participant recruitment and retention benefits?According to CTTI guidance, when should planning for decentralized elements begin?What action prevents massive data reconciliation efforts late in decentralized trials?