Data Safety and Monitoring Plan Example Form

Instructions and help about Data Safety And Monitoring Plan Example

a data and safety monitoring plan or dsm p is the system for appropriate oversight in monitoring of a clinical research study addie SMP promotes the integrity and validity of a study and enhances the safety and protection of the research subjects subject safety and data integrity and validity are its foremost considerations the National Institutes of Health recommends that all studies even those that pose little likelihood of harm should have a data and safety monitoring plan that is commensurate with the level of risk of the investigation the DSM P does not replace the investigators responsibility for required reporting the dsm p and/or date and safety monitoring board dsmb are intended to be complementary to other institutional and or governmental obligations a dsm p may vary between studies depending on its nature size complexity and risk level the plan require certain information for every study assessment of level of risk a plan for safety review by whom and how often with annuall