Sub-study and Ancillary Study Proposals

Process and Format

Revised: 15 Sept 2008

For all proposals submitted to the Natural History and Pathogenesis Committees Definitions

• “Sub-studies” are investigator-initiated studies that utilize previously collected data or samples from ARDSnet clinical trials. The studies may be related to the clinical issues addressed in the original trial, but the existing data and samples may also be used to address other questions.

• “Ancillary studies” are investigator-initiated studies that involve an extension of the main goals of an ARDSnet trial, and usually require collection of additional data or samples. Additional funds, independent of the ARDSnet contracts, are generally required for ancillary studies.