What data and data documentation will I deposit?

The deposition is centered around the Full Data Package, which is comprised of the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code from a PCORI-funded research project.

The concept of a Full Data Package is drawn from the 2015 Institute of Medicine Report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Our rationale for requiring the Full Data Package is to support the transparency and usability of the data and increase the likelihood that third-party requestors can analyze the data without additional assistance from the original investigators.