Decision Tree for Data and Safety Monitoring Plan

Table of Contents

• Graphical Flowchart
• Text Version of Flowchart
• Summary of Codes

See the main index of Decision Trees or Research Using Human Subjects

Graphical Flowchart

Credit: NIAID

Text Version of Flowchart

Step 1. Are human subjects involved? (even if exempted under 45 CFR Part 46)?

• If yes, continue to Step 2.
• If no:
  • The policy does not apply.
  • Human Subjects Code: 10.
  • End.

Step 2. Is a Clinical Trial (of any Phase) proposed?

• If yes:
  • Continue to Step 3.
• If no:
  • Plan not required.
  • End.

Step 3. Is Data and Safety Monitoring information provided?

• If yes:
  • Continue to Step 4.
• If no:
  • Absent. (Negative impact on score, bar to award, or application not reviewed)
  • End.

Step 4.

• Is the Data and Safety Monitoring plan complete?
  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 multi-site clinical trials of interventions with potential risk to participants.)
• Is this plan acceptable?
  • If yes:
    • Acceptable.
    • End.
  • If no:
    • Unacceptable
    • Negative impact on score.
    • End.

Summary of Codes

No specific codes are associated with evaluation as Acceptable or Unacceptable.