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.