Inclusion/Exclusion Criteria
A characteristic that participants must have to be eligible for the study.
What is an inclusion criterion?
The timing and sequence of all assessments, tests, and procedures throughout the study.
What does the Schedule of Events outline?
To ensure the safety of study participants and the integrity of the data collected.
What is the primary purpose of the DSMP?
Using the final study synopsis and protocol template to draft the initial protocol.
What is the first step in developing a clinical trial protocol?
Having a concurrent illness or condition that could interfere with the study results or participant safety.
What is an example of a common exclusion criterion?
Visit windows and/or timing allowances to accommodate participant availability and ensure protocol flexibility
What are elements of the SoE that help to accommodate participant availability and ensure protocol flexibility?
Safety monitoring procedures, reporting of adverse events, and data review processes.
What elements should be included in a DSMP?
The Protocol Initial Review Checklist
What is one document that should be reviewed and incorporated into the protocol during development?