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The following report template is intended to provide guidance and serve as a reference document for investigators, study staff, data managers, study statisticians and others involved in creating and submitting periodic reports to a Monitoring Body (e.g., Data and Safety Monitoring Board, Safety Officer).

Guidance for grantees who need to create a data and safety monitoring plan - multi-site - open session

Download the Guidance Document

Final

Issued by: National Institutes of Health (NIH)

Issue Date: December 01, 2018

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.