MARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: UKMCC-007.

00 Title: OnCore Type: Draft Approval UKMCC Director UKMCC Associate Director of Clinical Research 1. PURPOSE a. The purpose of this document is to describe the process for using OnCore. 2. SCOPE a. This procedure applies to all University of Kentucky Markey Cancer Center and the University of Kentucky Markey Cancer Center Affiliate Network personnel. 3. RESPONSIBILITIES a. All University of Kentucky Markey Cancer Center and the University of Kentucky Markey Cancer Center Affiliate Network personnel are responsible for following this SOP. b. Study staff will be responsible for the following, at minimum: i. Updating protocol status in OnCore ii. Registering patients in OnCore iii. Entering SAEs in OnCore iv. Assuring current study documents are attached in OnCore Signature Date

4. CROSS-REFERENCES a. None 5. ACRONYMS AND ABBREVIATIONS a. CCART Clinical Care and Research Team b. MCC-CRO Markey Cancer Center Clinical Research Organization c. MCC-CRO ARA - Markey Cancer Center Clinical Research Organization Administrative Research Associate d. UKMCC University of Kentucky Markey Cancer Center e. UKMCCAN - University of Kentucky Markey Cancer Center Affiliate Network f. PRMC Protocol Review and Monitoring Committee g. SIP Study Information Portal 6. DEFINITIONS a. None 7. PROCEDURE a. When a protocol is submitted to the MCC-CRO for review by the PRMC, it will be entered into OnCore by the MCC-CRO ARA staff according to the New Protocol Submission Form and the protocol. The PRMC number, study staff/managing group, CCART, and program area for the protocol are determined by the MCC-CRO ARA and entered in OnCore. b. The PRMC process and review details for each protocol will be tracked in OnCore. c. The DSMC timeline, determined by the PRMC at initial review, will be entered into OnCore. d. The DSMC process will be tracked in OnCore. e. The SIP will be configured for each study upon protocols submission. f. The OnCore Data Management Specialist will perform periodic quality checks on OnCore data to ensure that the data is current and accurate g. An OnCore account request form must be completed in order to request an Oncore user account, deactivate an OnCore user account, add protocol/treating staff, or remove protocol/treating staff .
CRP SOPs\Draft New Markey SOPs\ SOP Template 10-2010 Revised

i. Upon submission of the requested user account, the OnCore Administrator and the OnCore Data Management Specialist will determine the extent of access for the user based on their job responsibilitiesand the access requested. ii. Once a new account it created, the OnCore Data Management Specialist will provide appropriate training. h. The OnCore Data Management Specialist and the OnCore Administrator will assist with any difficulties utilizing OnCore. 8. DOCUMENTATION REQUIREMENTS a. The OnCore Account Request Form will document new user accounts and any changes to user accounts. 9. ATTACHMENTS a. None 10. REFERENCES a. None 11. REVISIONS HISTORY a. Revision: 00 b. Date: 22 November 2011 c. Description of Change: Initial document

CRP SOPs\Draft New Markey SOPs\ SOP Template 10-2010 Revised