Research Coordinator Conversion Guide

Introduction ................................................................................................................................................ 2

Getting Started ............................................................................................................................................ 3

Update your study administrative record ..................................................................................................... 4

Create the Patient Timeline (only applicable for 2 studies) ........................................................................... 7

Personalize your encounter linking reports .................................................................................................. 8

Link upcoming appointments to your study ............................................................................................................ 8

Review upcoming visit types ..................................................................................................................................... 9

Link upcoming admissions to your study (if applicable) ......................................................................................... 9

Link upcoming surgeries to your study (if applicable) ........................................................................................... 10

Review your participant enrollment information ........................................................................................11

Study Monitor Access .................................................................................................................................12

Release charts to study monitors in EpicCare Link ................................................................................................ 12

Introduction We are gearing up for our Epic go-live!

The purpose of this guide to is assist you in completing pre-live conversion activities needed for a successful clinical research go-live, including:

Confirming that your study is configured correctly in Epic.

Verifying your study participants are correctly enrolled in Epic.

Walking you through steps to create timelines for your study participants (only applicable for 2 studies).

Ensuring your first research visits after go-live are correctly associated with your study.

Before you begin Follow the topics below in order to ensure that your study is ready to be managed in Epic appropriately at go-live. If you do not conduct these activities prior to go-live, you’ll need to complete them upon going live.

Considerations for not doing this prior to go-live include:

The study administrative records will not have your study-specific set-up in place until you complete these steps.

Study teams who manage their studies outside of OnCore will need to be especially thoughtful to specify the study PI and study coordinators as soon as possible upon going live to ensure that study team members have access to the appropriate documentation tools in Epic.

Patient-study associations will need to be validated on the fly, alongside other work after going live.

Report personalization, which will improve efficiency in performing encounter-study association, will

not be available at go-live until these steps are completed. Encounter linking will need to be done on the fly as the patient comes in instead of being able to proactively link encounters from the report.

Resources The following resources are posted within Epic on your Learning Home Dashboard as well as Infoscope and Scout.

Item Description

Research Coordinator Conversion Guide Step-by-step instructions on pre-go-live updates to complete

Research QA Checklist An outline of the study-based tasks that need to be completed prior to go live

Epic/OnCore Status Crosswalk Outlines the OnCore statuses and equivalent Epic enrollment statuses along with Pre-Consent, Inactive, and Active bucket

Research Admin Field Ownership Doc Delineates which fields in the Study Maintenance record are owned by Research staff, OCRICC, analysts, or other

Getting Started You’ll be performing the following conversion steps in your live Production environment using your actual login credentials.

Logging in for the first time Before you begin the conversion steps, you’ll need to check that you have the appropriate security in Epic to do so.

1. Confirm you have received Froedtert Network Login Credentials (these will also double as your Epic login ID and password)

2. Log in to the Froedtert network via Froedtert Access 3. Confirm you have the Epic icon and a PLY icon.

a. The Epic icon is what we call Production environment b. PLY is our training environment. We highly encourage you to practice here to gain familiarity

with the application prior to working in production (Epic). 4. Log into Epic using your FH Network credentials

Locate Research tools in Epic Once you’re logged into Epic, you’ll want to verify your security is correct and that you have the Research tools. Do a quick check to confirm:

1. Locate the Chart Search box in the upper right hand corner of your screen 2. Type in the following terms and verify that your search displays the name of the activity (this means

you have access to it) a. Research Studies b. Research Administration c. Report Library

3. Next, locate your Learning Home Dashboard a. Select the My Dashboards tab on your home workspace

Note Critical Information The infographic below denotes important information for your conversion. Be to read these as you see them throughout the document.

Important information will be displayed here

Update your study administrative record The following activities will be completed vis the Study Maintenance activity. This record has a number of fields used for the administration of the study within Epic. At times, it is not the research coordinator who is responsible for a given field. Please reference the Research Record Field Ownership aide on your Learning Home Dashboard for more information on specific fields and their respective ownership.

Update the study type (OnCore and non-OnCore studies) All active studies will need their study type updated.

1. Click Study Maintenance on the main toolbar.

2. Enter the study's name and ID, and click Accept. 3. On the General Information form, enter the correct study type.

Optionally Update the study links (OnCore and non-OnCore studies) You have the option to specify to specify links to point to the research protocol document, a recruitment website, or another resource useful for researchers or patients. These links can appear:

In Hyperspace in the Research Studies activity In MyChart as part of a recruitment effort

1. On the Studies Activity Setup form, enter the URL, Display Name, and where you’d like the link to show.

Optionally Update the adverse events (OnCore and non-OnCore studies) If you will be documenting adverse events in Epic, you have the option of using adverse event term sets CTCAE version 4.03 and 5.0. The default is set to version 5.0. You only need to make an update if you’ll be documenting adverse events in Epic and will be using CTCAE 4.03 instead of 5.0.

1. On the Studies Activity Setup, navigate to Adverse Events > Term Sets and update to the appropriate version.

Please work with the PI and your study team to discuss the instances in which this field will be

utilized.

Studies utilizing a previous version of the CTCAE should not use this activity. The default of

version 5.0 will remain, but would not be utilized by the study team.

Optionally Update ROI Special Attention default (OnCore and non-OnCore studies) If HIM release of information staff should contact you before releasing the patient’s record to someone other than the study monitor, you can update the ROI Special Attention field on the Report Groupers form in the study record. By default, all studies will be marked as “Always ok to release” unless you specify otherwise.

1. On the Report Groupers, navigate to ROI Special Attention and update to “Contact study team” or “Never ok to release” as needed.

“Never ok to release” status would be determined via OCRICC through the vetting process. Staff

would be directed as appropriate if their study is impacted

Optionally Update study notification defaults (OnCore and non-OnCore studies)

Please contact the PI or Research Coordinator before adding the notifications on their behalf

You have the ability to change who will be automatically notified for things such as study patient admissions, appointment changes, and procedure results. By default study coordinators listed in the study record will be notified of study patient admissions, emergency room arrivals, and procedure results. You only need to make adjustments if you need to turn off notifications or change the recipients. Overriding defaults must be done per study/trial.

The following updates will be made on the Automated Actions form in the study record if applicable:

1. Add a Trigger Action and a Follow-Up Extension of:

Notification Desired Trigger Action Follow-Up Extension to Select

If you want both coordinators and the PI to receive notifications about admissions and emergency room arrivals

ADT Event RSH ADT EVENT NOTIFICATION – COORDINATORS AND PI

If you want to turn off notifications for admissions and emergency room arrivals

ADT Event OVERRIDE STUDY NOTIFICATION OF ADT EVENT

If you want both coordinators and the PI to receive appointment change notifications

Appointment Notification

RSH APPOINTMENT NOTIFICATION - COORDINATORS AND PI

If you want to turn off notifications for appointments

Appointment Notification

Suppress Research Study Appointment Notifications

If you and the PI want to receive all results connected to the study

Procedure Result RSH RESULTS ROUTING STUDY USERS- CC COORDINATORS AND PI

If you and the PI only want to receive abnormal results connected to the study

Procedure Result RSH RESULTS ROUTING STUDY USERS- CC COORDINATORS AND PI ABNORMAL ONY

If you only want to receive abnormal results connected to the study

Procedure Result RSH RESULTS ROUTING STUDY USERS- CC COORDINATORS ABNORMAL ONLY

Specify which users are involved with the study (non-OnCore studies) You must list coordinators on the Users and Providers form in order to assign them as the research coordinator for a patient. Staff members listed here have additional study-specific access for tasks such as running reports and linking encounters to the study.

1. For studies entered manually in Epic, enter the names of the users who will be involved with this study on the Users and Providers form, such as the following:

Principal investigator

Study coordinators

Other Providers (use this field for co-Is and sub-Is)

Specify study status (non-OnCore studies) All active studies will need their study type updated.

1. Click Study Maintenance on the main toolbar.

2. Enter the study's name and ID, and click Accept. 3. On the General Information form, enter the correct Study Status.

Optionally specify study arms (non-OnCore studies) If your study has branches or arms, you can specify those in Epic. This will allow you to associate your study patients to a particular arm in the Research Studies activity.

1. On the Study Calendar form, navigate to the Study Branches field and specify your arms in the Branch ID and Branch Name fields.

Confirm your study has migrated appropriately Verify that your study migrated from OnCore to Epic with a subset of patients. Send an email to

oncore@mcw.edu to confirm that your study has moved appropriately.

Create the Patient Timeline (only applicable for 2 studies) When you enroll a patient in a study with a defined billing protocol, you can generate that patient's timeline. A patient's study timeline includes the date ranges when each set of charges is expected to occur. Timelines help the system determine where to route charges. These charges generally correspond to specific study visits or a related group of study visits.

When you create a patient timeline, the system uses the billing protocol for the study to generate a specific timeline for the patient.

Timelines for impacted studies will need to be done as soon as possible upon going live. Any

charges that are generated for the patient without the timeline applied will not be pre -routed to

the appropriate billing bucket and will need to be done manually by OCRICC and/or MCW billing

specialists.

Studies Going Live on 10/21/20

PRO00033707 (MCW IRB) Teneobio- TNB-383B: A Multicenter, Phase 1, Open-label, Dose-escalation and

Expansion Study of TNB-383B, a Bispecific antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

NMDP RR 19-108 (Central IRB) CTN-1703-1801: A Randomized, Multicenter, Phase III Trial of

Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-

Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Create the timeline

1. Click Research Studies on the main toolbar and select your patient.

2. In the Patient Timeline and Associated Encounters section, click Create a Timeline.

3. Select the appropriate billing calendar for the study and click Accept.

Note: If there is only one billing protocol for a study, it will appear automatically.

4. Typically, you would enter the date for the patient’s initial study visit in the From Date field. For conversion, however, we’ll only include visits occurring after go-live, on October 21, 2020. Determine which visit will be the first to occur at or after go-live, and specify the expected visit date for that visit in the From Date, then press Tab.

Including dates prior to go-live in the patient timeline may cause charges for services rendered

prior to go-live to be caught for Research Billing Review. After creating your patient timeline, only

link patient encounters to the study starting with visits scheduled for October 21, 2020 and

beyond.

5. In the Patient Timeline window, click Set Subsequent Dates to automatically fill in the dates for the

rest of the patient calendar according to the study calendar.

6. Click Accept.

Personalize your encounter linking reports You will personalize reports that will be used for encounter-study linking. These include reports that show: upcoming appointments, upcoming admissions, and upcoming surgeries.

From the Research Coordinator Radar dashboard, navigate to the Research Reports section.

1. Personalize the Upcoming Appts for Patients Associated with <REPLACE WITH YOUR STUDY> report.

2. Hover over Ready to Run to the right of the report name, click on the dropdown arrow, and click Edit.

3. Click on the Research Study field and replace the Research Study ID with your study.

4. Click Save As.

5. When prompted to specify a new report name, update the portion of the report that says “<REPLACE WITH YOUR STUDY>” with your study’s name.

6. If you’d like to share this report with any other coordinators, go to the General tab and insert the other study team members’ names in the Share Report > With Users field.

7. If your study patients will have research-related admissions, personalize the Upcoming/Current Admissions for Patients Associated with <REPLACE WITH YOUR STUDY> report using the same steps listed above for the upcoming appointments report.

8. If your study patients will have research-related surgeries, personalize the Upcoming Parent Admissions Linked to Surgical Cases for Patients Associated with <REPLACE WITH YOUR STUDY> report using the same steps listed above for the upcoming appointments report.

Link upcoming appointments to your study From your version of the report, you can review upcoming visits for your study participants and verify any study-related visits scheduled for go-live and beyond are appropriately linked to the study.

1. Run your saved report created from the Upcoming Appts for Patients Associated with <REPLACE WITH YOUR STUDY> report.

2. Review the appointments to determine which, if any, are already linked to your study.

3. If an appointment is not linked to your study but should be, select that appointment and click Link to Study on the report toolbar.

4. Select the study to which the appointment should be linked. 5. If this study has a billing protocol, you’ll be prompted to link this appointment to a specific day on the

patient’s timeline. This is only applicable to the studies piloting this tool. If your study isn’t a pilot, skip this step.

6. Click Accept.

Review upcoming visit types Effective 10/21/20, updates to the following visit types will take place as part of the Epic Research Application go-live. Present-day scheduling workflows will remain the same.

For those who use ERS/NRS today, little should change. Research staff will indicate the appropriate Visit Type to be utilized.

Any future needs/use for those visit types will be tied to specific research projects and will be vetted as part of the operational planning done for such research projects through FH OCRICC.

o Vetting of individual research occurs with the FH leadership of that department.

Notify schedulers if any upcoming appointments need to be updated.

Visit Type Status on

10/21/20

Definition

New Research Patient- NRS [113]

Will remain A patient who is new to the specific study/trial for which the appointment is being requested. This will be determined by research staff and communicated for scheduling purposes.

Established Research Patient - ERS [112]

Will remain A patient with an active or follow-up status on the study/ clinical trial for which the visit is being requested. This will be determined by research staff and communicated for scheduling purposes.

Research Visit [18] Retired N/A – Appts with this visit type will be converted prior to go live. Communication will be sent to those impacted with further direction.

Link upcoming admissions to your study (if applicable) From your version of the report, you can review upcoming planned admissions for your study participants and verify any study-related admissions planned for go-live and beyond are appropriately linked to the study. Complete the steps below if applicable to your study

1. Run your saved version of the Upcoming/Current Admissions for Patients Associated with <REPLACE WITH YOUR STUDY> report.

2. Review the admissions to determine which, if any, are already linked to your study.

3. If an admission or pre-admission is related to your study, select that encounter and click Link to Study on the report toolbar.

4. Select the study to which the admission should be linked. 5. If this study has a billing protocol, you’ll be prompted to link this appointment to a specific day on the

patient’s timeline. This is only applicable to the studies piloting this tool. If your study isn’t a pilot, skip this step.

6. Click Accept.

Link upcoming surgeries to your study (if applicable) From your version of the report, you can review upcoming planned surgeries for your study participants and verify any study-related surgeries planned for go-live and beyond are appropriately linked to the study. Complete the steps below if applicable to your study

1. Run your saved version of the Upcoming Parent Admissions Linked to Surgical Cases for Patients Associated with <REPLACE WITH YOUR STUDY> report.

2. Review the surgeries to determine which, if any, are already linked to your study.

3. If a surgery is related to your study, select that encounter and click Link to Study on the report toolbar.

4. Select the study to which the surgery should be linked. 5. If this study has a billing protocol, you’ll be prompted to link this appointment to a specific day on the

patient’s timeline. This is only applicable to the studies piloting this tool. If your study isn’t a pilot, skip this step.

6. Click Accept.

Review your participant enrollment information

Before you begin

Confirm that the study was brought over from OnCore

As part of the Research implementation project the patient-study association status list was standardized with OnCore’s status list. Your patient’s association status was updated to reflect the new statuses. Use this opportunity to review your study participants’ enrollment information for accuracy.

To pull up the Research Studies activity for each patient:

1. Click Research Studies on your main toolbar. 2. Look up your patient and click Accept. 3. Review the study-specific enrollment information for your patient for accuracy. 4. For studies managed in OnCore, if changes are needed, these changes should be made directly in

OnCore and the updates will be interfaced into Epic. 5. For studies managed outside of OnCore, make any necessary changes indirectly in Epic from the

Research Studies activity.

Generate a list of all patients associated with your study in Epic

1. Run the Patients Associated with My Studies report from your Research Coordinator – My Studies dashboard.

2. From the results, you can select a patient and click Research Studies in the report toolbar to jump to their Research Studies activity.

3. You can use this report to quickly generate a list of patients to review, rather than looking them up via the Research Studies activity individually. View the Research SnapShot for more information.

4. Be sure to verify all your patients are appearing in the report as expected before using it as a work list.

Study Monitor Access

Release charts to study monitors in EpicCare Link External study monitors can review documentation completed in Epic via EpicCare Link. If you plan to have monitors completing monitoring visits at or shortly after go-live, you can release the needed patient charts to them for review proactively.

Note: Monitors that are already in EpicCare link will continue to use the system in the same way.

Monitors in EpicCare Link prior to New Monitors in EpicCare Link 10/21/20 and

later

Pre Go-Live Research Monitors will continue with the current process post go-live in which each monitor has their own Patient/Provider group.

The releasing of records will stay as it is today post go-live.

Post Go-Live Monitor requests will be approved by the appropriate research staff for that study.

Existing monitors who need access to new patients/studies will continue with their current process that is in place prior to 10/21. *Monitor will notify HIM upon request of new study/patient relationship

After study monitors receive access to the EpicCare Link web portal, you'll use a report to release information to them.

1. Run the Patients Associated with My Studies report from your Research Reporting Home dashboard. 2. Open the report results. 3. Select the patients whose records you want to release to the study monitor.

4. Click Release to Study Monitor on the toolbar. 5. Select the study, patient group, and the dates the information should be available to the study

monitor.

6. Click Release.

You can view release information in the Study Monitor Release Information section of the Research Snapshot and in the Study Monitor Releases for My Studies component on the Research Reporting Home dashboard.