What information describes the expected duration of subject participation and the sequence of all trial periods?

• A. The expected duration and sequence/duration of all trial periods, including follow-up
• B. The recruitment timeline
• C. The site locations
• D. Data management plan

Answer: (A)

Understanding how the protocol describes the duration of subject participation and the sequence of trial periods is essential. This information is captured as the study timeline or participant timeline, detailing how long a subject will be involved (from screening through follow-up) and the order of all phases and visits. It’s what guides scheduling, monitoring, and the informed consent process, ensuring participants know the time commitment and investigators can plan procedures accordingly. Recruitment timelines, site locations, and the data management plan serve other purposes: recruitment timing, site logistics, and how data are collected and handled, not the overall participation duration or the sequence of study periods.