The CDASHIG Comments (CO) domain describes free text collected alongside other data on typical CRF pages (e.g., Adverse Events) when there is not a specified variable for the free text. The CDASHIG CO domain has no mandatory data elements for inclusion in a separate Comments CRF, and the recommendation is to avoid creating a General Comments CRF.
A stand-alone Comments (CO) domain CRF was intentionally not included in the eCRF Portal. CDASHIG recommendation is to avoid creating a General Comments CRF; however, implementers may still decide to include a free-text comment field within any CRF utilizing CDASH variable naming conventions (e.g., COVAL) when deemed appropriate. Refer to the CDASHIG for further recommendations on the CO Domain.