For protocols entered into OnCore for non-oncology, what data must be documented or tracked?

Purpose

This document describes the information required for data entry for non-oncology protocols OnCore.

Responsibilities

The study team is responsible to enter the required information.

Instructions

The following information should be entered for protocols maintained in OnCore:

  • Protocol information such as title, sponsor, accrual goals, and study completion dates, etc.

  • Regulatory and committee information such as approval dates, change of protocol dates, consent version dates, etc.

  • Research group information such as staff assigned to the protocol, fund account information if billable procedures.

  • Subject demographic information.

  • Study visit documentation to confirm procedures were performed, etc (note: for studies that include billable UWHC/UWMF procedures, this information must be entered within 24 hours of conducting the study visit to ensure all parties are billed appropriately).

Document History

Document History
Reviewed Date Change Reason Approver
01/02/2024 Updated document style. Marc Buehler


Keywords:
faq oncore required requirement mandatory information 
Doc ID:
12776
Owned by:
Marc B. in SMPH Research Informatics
Created:
2009-11-30
Updated:
2024-01-02
Sites:
SMPH Research Informatics