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Phase III Trials

NIH’s definition of a Phase III clinical trial is quite broad, including drug studies, device studies, behavioral interventions, epidemiological studies, community trials, and more. Phase III trials are usually large, prospective trails that compare two or more interventions against other standard or experimental interventions.

Data Management and Sharing Plan Format Page

Description

Optional format page for preparing the plans required in applications subject to the Data Management and Sharing (DMS) and/or Genomic Data Sharing (GDS) policies for due dates on or after January 25, 2023.

How to Access

Data Management and Sharing Plan Format Page

Instructions

Instructions for developing a data management and sharing plan are included in the latest version of the NIH Application Guide (research; career development).

Samples
Writing a Data Management and Sharing Plan

Updated Date
January 2023

Sex As a Biological Variable

NIH expects that sex as a biological variable (SABV) will be factored into research designs, analyses, and reporting in pre-clinical and clinical studies. Accounting for SABV helps interpret and validate research findings, as well as enhances the rigor, reproducibility, and applicability of biomedical research. But how exactly do you account for SABV?