Visit X Time Point Introduction Background Information This section is to include brief background information for this trial. It will not be a copy of the background information from a grant application. Include: A brief description of the health problem that the study will address The name and description of the study intervention/study product(s) Discussion of important research relevant to the study that provides background and scientific justification for the study (include findings from in vitro studies, preclinical in vivo studies, and relevant clinical trials) A brief description of the study’s overall goal Applicable clinical, epidemiological, or public health background or context of the Importance of the study and any relevant treatment issues or controversies <Insert text> Rationale for the Proposed Study Include a description of, and justification for, the route of administration, dosage, dosing regimen, intervention periods, or behavioral intervention methods and selection of study population. Include a statement of the hypothesis. <Insert text> Correlative Studies <Insert text> Potential and Benefits Include in Sections 0 and 0 a discussion of known risks and benefits, if any, to human participants. Be sure that information in these sections is consistent with your consent document.
Visit X Time Point Introduction Background Information This section is to include brief background information for this trial. It will not be a copy of the background information from a grant application. Include: A brief description of the health problem that the study will address The name and description of the study intervention/study product(s) Discussion of important research relevant to the study that provides background and scientific justification for the study (include findings from in vitro studies, preclinical in vivo studies, and relevant clinical trials) A brief description of the study’s overall goal Applicable clinical, epidemiological, or public health background or context of the Importance of the study and any relevant treatment issues or controversies <Insert text> Rationale for the Proposed Study Include a description of, and justification for, the route of administration, dosage, dosing regimen, intervention periods, or behavioral intervention methods and selection of study population. Include a statement of the hypothesis. <Insert text> Correlative Studies <Insert text> Potential and Benefits Include in Sections 0 and 0 a discussion of known risks and benefits, if any, to human participants. Be sure that information in these sections is consistent with your consent document.
SKCC%20Protocol%20Template%20-%20Interventional%20(2017-02-09)%20FINAL%20clean.docx