Decision Tree for Data and Safety Monitoring Plan -- Text Version

Decision Trees      How to Write a Human Subjects Application

1. Entity responsible for monitoring is described? and
2. Policies and procedures for adverse event reporting are described? and
3. Plan is appropriate with respect to risks to participants, complexity of study design, and methods for data analysis? (NIH requires a Data and Safety Monitoring Board for multisite clinical trials of interventions with potential risk to participants.)

Is this plan acceptable?

To continue, click Yes or No