Table 2.

Hierarchical nesting architecture of CDE framework with a detailed view of the CDEs contained in the donor information subsection

Module	Section	Subsection	CDE
Project
Research System
Manufacturing/Production	Source/Donor	Donor information	Donor organism
			Sex
			Age
			Race
			Ethnic group
			Donor genetic information
			Health/disease status when obtained
			Donor permission
		Anatomical origin
		Source cell information
	Critical Quality Attributes
	Critical Process Parameters
In-depth Product Characterization
Outcomes/Findings

The module column lists the five modules of the framework. The section column details the sections of the manufacturing/production module. The subsection column details the subsections of the source/donor section. The CDE column lists the CDEs that belong to the donor information subsection.