Who approves my data monitoring plan?
Though your monitoring
plan has gone through peer review, you will
work with NHLBI to make the final decision about safety monitoring before you
send the protocol to your IRB or before you begin the study. Discuss
this topic with your Program Director early in the process
and decide on an adequate plan. Then submit your protocol
with the data monitoring plan to your IRB for review. NHLBI
requires that your IRB approve the monitoring plan as well
as the protocol, consent forms and other documents.
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov