Ive heard that I need to present plans for data safety monitoring in some applications. What is expected?
In the NIH Guide of June 2000 and June 1998 ((http://grants.nih.gov/grants/guide/notice-files/not98-084.html), NIH announced that investigators must submit a monitoring plan for phase I, II and III clinical trials to the funding Institute and Center (IC) before the trial begins. Further, a general description of the monitoring plan must be submitted as part of the research plan section of the application. Reviewers will comment on the adequacy of that general plan. They will look to see if it is appropriate with respect to the data management plan and potential medical safety risks. In particular, the general plan will be examined for a description of how Adverse Events will be reported to the IRB, NIH, the Office of Biotechnology Activities (if required) and the FDA. Your NIDA project officer can help you determine the elements you need to address in this general description. Guidelines for developing a data and safety monitoring plan are available at the NIDA website at http://www.dr
