Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees

الملخص

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.