New Research Access Processes IU Health Research Access Team Effective August 15, 2019 9/18/2019

Research Access Key Points Paper request process retiring effective August 15 REDCap for Non-IU Health; SOLAR for IU Health Approved (all) and managed (non-IU Health) by IU Health Research Access Team Lawson and eLMS (learning management) Mandatory annual education modules Current IRB Approval/Exemption Cerner access levels will be aligning with Model Implementation Dates: New Users- August 15, 2019 Existing Users- August 15-December 31, 2019

Research Access- REDCap/SOLAR Type of access needed Who requests access How to submit a new request Research Monitor Research staff responsible for the protocol to be monitored Click on this link to complete the REDCap survey-   https://redcap.uits.iu.edu/surveys/?s=X837WXEF7R Note: You will need the full name and e-mail address of the monitor as well as the OnCore protocol no. Additional details on this process can be found in the Research Monitor Policy and a companion job aid. Research Study Staff (Not employed by IU Health or not medical students) Individual needing access https://redcap.uits.iu.edu/surveys/?s=AC7JXK9XEY Note: You will be asked to provide the name and phone number for your supervisor/manager in the event that follow-up is needed and a copy of one of the current IRB approval letters for your studies. Research Study Staff (IU Health Employees) Individual needing access or their manager Click on this link to request research access- https://iuhservicemanager.iuhealth.org/CherwellPortal/winlogin Note: You will need your NT logon and password.

Research Access- Works Web Works Web is the new IU Health web interface used for launching streamed applications such as Cerner via Citrix Navigate to https://works.iuhealth.org in your internet browser. Sign in using your IU Health user name and password. Perform Duo authentication. (IU DUO users will need a separate IU Health DUO account.) Click on Cerner Home Remote icon. (This may take a few moments to open.) Click on the PowerChart PROD icon.

Research Access- eLMS Sign in to Works Web. Click on eLMS icon. If the icon is not in your favorites folder when you open IU Health Works Web, click on All Apps and scroll down to eLMS. Click on the star to turn it gold and add to your favorites.

Research monitor access

Research Monitor Access Changes Replacing Patient Lists with PowerChart Research Viewpoint Will require protocols and subjects be up to date in OnCore and PowerTrials Access requested by the research staff via a REDCap survey and managed by IU Health Research Access Team in PowerTrials Provisioned for the life of the trial New Policy Access granted via PowerTrials- important to keep OnCore and PowerTrials synced Alternative to PowerTrials is printed source documents that must remain on-site under the purview of the principal investigator or delegated study team. Monitors will be provided job aid and copies of applicable policies via e-mail at the time access is granted. Research staff initially requesting access will be copied. Monitors will need to take mandatory training through eLMS Implementation Date Range: August 15 for new requests August 15-December 31 for existing monitors

Research Monitor Access Steps Initial REDCap request submitted by research study coordinator or manager Must provide full name E-mail address, phone contact information OnCore protocol(s) that monitor will need access to IU Health Research Access (IUHRAT) reviews for completeness and sends REDCap survey to monitor for additional demographics and data security agreement Monitor completes survey and is approved by IUHRAT and sent to Lawson. Monitor is granted access to Cerner PowerChart. E-mail sent by IUHRAT team System logon and temporary password Job Aid Policies Instructions on accessing eMLS for mandatory training Research coordinator/manager who initiated request receives copy of e-mail notification sent to monitor minus the logon and password information. Monitor completes eLMS and notifies IUHRAT. IUHRAT adds monitor to protocol(s) in PowerTrials IUHRAT will removed the monitor from the protocol in PowerTrials when the IRB Study Closure notification is received from OnCore.

Research Monitor Access- Viewpoint Open Research Viewpoint Click on Protocol hyperlink

Research Monitor Access- Viewpoint Click on Enrolled Patients tab

Research Monitor Access- Viewpoint Click on hyperlink Patient Name to open medical record

Research Monitor Access- Viewpoint

NON-iu health employee research access

Non-IU Health Research Access Steps Initial REDCap request submitted by research study coordinator Demographics Supervisor contact information Data security agreement IU Health Research Access (IUHRAT) reviews for completeness, approves and assigns level of access Added to Lawson and access is provisioned to Cerner PowerChart E-mail sent by IUHRAT team System logon and temporary password Job Aid Policies Instructions on accessing eMLS for mandatory training Coordinator completes eLMS

IU health employee research access

IU Health Research Access Steps Use new SOLAR process https://iuhservicemanager.iuhealth.org/CherwellPortal/winlogin Click on the “Submit a SOLAR” link. Click on the” Create a New SOLAR” button. Sign the SOLAR Data Stewardship Agreement. Select the “Cerner” option and then Select “Clinical Research”

IU Health Research Access Steps Complete/Verify the contact information and complete the business justification section. Then click “Next”. Pick either “Add Access” for new or changed access or “Remove Existing Access” to inactivate access. Select one of the following positions. Once selected, click “Add to Cart” Submit your ticket by clicking on “Submit Order” Access with be approved by manager first then sent to IUHRAT for level of access review and approval.

Research Access Summary Paper request process retiring effective August 15 REDCap for Non-IU Health; SOLAR for IU Health Approved (all) and managed (non-IU Health) by IU Health Research Access Team eLMS mandatory annual education modules Current IRB Approval/Exemption Cerner access levels aligning with Model Implementation Dates: New Users- August 15, 2019 Existing Users- August 15-December 31, 2019 by invitation

Resources Access Support IUHealthResearchAccess@iuhealth.org PowerTrials/OnCore RPE Support Cheryl Yacone BSN, RN Sr. Clinical Analyst, IS Research Team cyacone@iuhealth.org (317) 963-0545 OnCore Support oncore@iupui.edu (317) 278-2600 Office of Clinical Research Website (training materials) https://ocr.iu.edu/ 9/18/2019