title: Considerations in developing data and safety monitoring plans: a framework.
authors.affiliation: Institute for Clinical Research and Health Policy Studies and The Department of Medicine, Tufts-New England Medical Center, NEMC Box 63, 750 Washington Street, Boston, MA 02111, USA.
authors.forename: Deborah R
authors.initials: DR
authors.lastname: Zucker
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D006801:Humans; D012449:Safety