OnCore: DFD - Rare Disease

Field Name	Definition	Requirement Entry Instructions	Responsible for Entry	QA
Rare Disease	Indicates whether a rare disease is under study of the protocol.	Required Oncology: Rare disease should be set to 'Yes' if one or both of the following cases apply: The disease is defined as rare (<6/100,000 a year) on the Rare Cancer List. The disease is a molecular or biologically defined subset such that annual incidence is <20,000 in the USA. Non-oncology: Select 'Yes' for diseases that affect fewer than 200,000 people in the United States per year.	PC Console edit / PRMC Coordinator (UWCCC) or Protocol Coordinator	No

Field Name

Definition

Requirement
Entry Instructions

Responsible for Entry

Rare Disease

Indicates whether a rare disease is under study of the protocol.

Required

Oncology: Rare disease should be set to 'Yes' if one or both of the following cases apply:

The disease is defined as rare (<6/100,000 a year) on the Rare Cancer List.
The disease is a molecular or biologically defined subset such that annual incidence is <20,000 in the USA.

Non-oncology: Select 'Yes' for diseases that affect fewer than 200,000 people in the United States per year.

PC Console edit / PRMC Coordinator (UWCCC) or Protocol Coordinator

Keywords:

rare disease

Doc ID:

103287

Owned by:

Molly H. in SMPH Research Applications

Created:

2020-06-23

Updated:

2025-06-06

Sites:

SMPH Research Applications