OnCore: DFD - Annotations: Does this study have an external DSMB (or equivalent)?

Field Name	Definition	Requirement Entry Instructions	Responsible for Entry	QA
Data and Safety Monitoring Board: Does this study have an external DSMB (or equivalent)?	Non-UW entity (e.g., sponsor/CRO, NCI) is responsible for monitoring study data.	Not Required Oncology: Select 'Yes' if external DSMB Non-oncology: Not used	PC Console edit / Regulatory Coordinator	No

Field Name

Definition

Requirement
Entry Instructions

Responsible for Entry

Data and Safety Monitoring Board: Does this study have an external DSMB (or equivalent)?

Non-UW entity (e.g., sponsor/CRO, NCI) is responsible for monitoring study data.

Not Required

Oncology: Select 'Yes' if external DSMB

Non-oncology: Not used

PC Console edit / Regulatory Coordinator

Keywords:

DSMB

Doc ID:

138543

Owned by:

Molly H. in SMPH Research Informatics

Created:

2024-07-19

Updated:

2024-09-19

Sites:

SMPH Research Informatics