National Cancer Institute (NCI) Study Close under the caBIG TM Program SOP No: CR-008 Effective Date: XX/XX/XXXX Ensure all coding of clinical events has been completed to date, including SAE reconciliation Study Coordinator Study Coordinator and Clinical Data Management Quality Assurance Auditor Gain joint agreement from the Statistician and Clinical Data Management for clinical database closure Inform Quality Assurance than the database is ready for QA Audit Audit the database for accuracy and completeness Ensure all required activities have taken place Provide Study Coordinator and Clinical Data Management with any questions/comments Resolve QA Auditor concerns, as appropriate Provide QA Auditor with resolutions and/or any changes made to database Audits changes and reports back to Study Coordinator on audit results Inform Study Programmer that the clinical research database can be extracted for analysis 1

National Cancer Institute (NCI) Study Close under the caBIG TM Program SOP No: CR-008 Effective Date: XX/XX/XXXX Close the clinical research database upon the request by the Study Coordinator, restricting all write- access to the clinical research team Study Programmer Statistician Notify the members of the Clinical Study Team the date of the database closure Create data exports or extracts of the clinical research trial data to support interim data analysis by the Statistician Review data to check for accuracy and completeness Perform interim analysis of the data according to the methodology outlined in the SAP and using tested programs Study Coordinator Request the Study Programmer re-open the database Resolve errors Review output for data accuracy and layout of tables, listing, and graphs 2 1 Errors? No Yes 1

National Cancer Institute (NCI) Study Close under the caBIG TM Program SOP No: CR-008 Effective Date: XX/XX/XXXX Report and coordinate with Clinical Study Team, Clinical Data Management, and QA Auditor on any data issues Statistician Analytical Programmer Request any additional programs or changes to existing programs 2 Resolves issues by modifying programs per IT-005 (SOP for Standard Programming) Update the SAP per CR- 013 SOP for Statistical Analysis Plan and develop new programs per IT-005 SOP for Standard Programming Communicate analysis results to appropriate authority (i.e., Clinical Study Team, FDA, DSMB or IRB) for reporting, as required 3 Addition al program s or changes ? Yes No

National Cancer Institute (NCI) Study Close under the caBIG TM Program SOP No: CR-008 Effective Date: XX/XX/XXXX Ensure any changes made to the clinical database during the interim analysis process are properly documented Study Coordinator and Clinical Data Management Study Programmer Ensure the QA Auditor has audited any changes made to the database 3 Removes restrictions on write access to the clinical research study to allow for continued data entry Request, if appropriate, Study Programmer create data exports or extracts of updated clinical research trial data for analysis Requests the study to be re-opened after analysis is complete Study Coordinator Inform the Programmer that the analysis is complete