ANALYSES references should be for non-NIH funded studies, refer to “DSMB”; When approximately 50% of patients have the” DMC.” Sample text: completed the study through Visit X, an interim analysis for safety will be conducted by an independent data monitoring committee. Serious adverse events will be monitored by the committee on an ongoing basis throughout the study. STATISTICS Describe plan for analyzing the primary endpoint. Primary Analysis Plan Rationale for Number of Subjects BACKGROUND Identify the product to be studied, and describe it briefly. Overview of Non-Clinical Studies Provide a brief summary of the non-clinical data that has clinical significance. Overview of Clinical Studies For more detail refer Provide a brief summary of the clinical data that are relevant to the study. to the Investigator’s Brochure. (or, for approved drugs, to the Prescribing information.
ANALYSES references should be “DSMB”; for non-NIH funded studies, refer to the” DMC.” Sample text: When approximately 50% of patients have completed the study through Visit X, an interim analysis for safety will be conducted by an independent data monitoring committee. Serious adverse events will be monitored by the committee on an ongoing basis throughout the study. STATISTICS Primary Analysis Plan Describe plan for analyzing the primary endpoint. Rationale for Number of Subjects BACKGROUND Identify the product to be studied, and describe it briefly. Overview of Non-Clinical Studies Provide a brief summary of the non-clinical data that has clinical significance. Overview of Clinical Studies Provide a brief summary of the clinical data that are relevant to the study. For more detail refer to the Investigator’s Brochure. (or, for approved drugs, to the Prescribing information.
Protocol_TemplateFEB2017.docx