Clinical research can be complex and is governed by many laws, regulations, and policies that depend upon the nature of the research. Some factors to consider include whether investigational (unlicensed) products are to be studied, the type of disease or condition, restrictions on participation, potential risks, and whether a study will occur in more than one country.
The reference materials below are grouped according to the stage of research: How a study should be planned or designed; how a study should be conducted; and how the conduct of the study should be monitored.
Please note that no single list of reference materials is comprehensive. The documents provided here are relevant to many NICHD-supported clinical research projects and are intended as examples.
When using these resources, please keep in mind that laws and regulations must be followed, while guidance documents and points to consider are generally binding if institutional resources or collaboration is involved.