Decision Tree for Data and Safety Monitoring Plan -- Text Version
Decision Trees NIAID Human Subjects Application and Grant Handbook
Is the Data and Safety Monitoring plan complete?
- Entity responsible for monitoring is described? and
- Policies and procedures for adverse event reporting are described? and
- 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, choose Yes or No |
