NIH Protocol Template for Behavioral and SOcial Sciences Research INvolving Humans
This tool from the NIH offers a template for writing experimental protocols. It is an effective resource for communicating the science, methods, and operations of a clinical trial, to allow for efficient review by peers and oversight bodies, to facilitate reporting of information into ClinicalTrials.gov, and to guide replication of studies. Use of the template will also help ensure adherence to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines. Though not required, the template can be especially helpful for investigators less familiar with the information and level of detail expected in a clinical protocol.