EPIC Research and RAC - University ... - University of …media.news.health.ufl.edu/misc/rac/rac_internal/RAC_EPIC...EPIC Research and RAC ... (in xxxx‐xxxx format) o Billing contact

EPIC Research and RAC 2/14/2012

Page 1 Research Administration and Compliance

Table of Contents

1. RAC Review for Epic Upload ....................................................................................................................... 2

Set Epic Study Upload Box ............................................................................................................................... 2

Obtain (W)IRB Number .................................................................................................................................... 2

Create Epic Study Code ..................................................................................................................................... 3

2. Epic Study Creation – Automatic Program <Coming Soon> ......................................................... 4

3. Create Studies in Epic via Hyperspace ................................................................................................... 5

RAC Epic Access ................................................................................................................................................... 5

Study Creation Data Preparation .................................................................................................................. 5

Log In to Epic Production Hyperspace ....................................................................................................... 5

Verify Study Does Not Already Exist in Epic ............................................................................................ 7

Create a New Study in Epic .............................................................................................................................. 8



1. RAC Review for Epic Upload

Set Epic Study Upload Box

Beginning December 1, 2011, all UF clinical research studies that meet at least ONE of the following criteria must be uploaded into Epic:

The study has protocol‐required potentially billable service(s) that will be conducted in a Shands or UFP facility (regardless of payer), OR

The study involves an investigational drug or device.

During RAC review, the RAC secondary reviewer will determine if a study meets the Epic upload requirement, and set the Epic Upload box in RAC DB accordingly.

If Epic Upload box is set to “Yes”:

Secondary reviewer will determine the Guarantor Type for the study. Check the Medicare Status on top of the billing grid. There are three options to choose from:

RAC DB Guarantor Type Epic Guarantor Type Name Epic Guarantor Type ID

104 Research Research 104 124 Req V70.7 & Q Modifiers Medicare Qualifying Study 124 125 Device Req CMS Approval Device/CMS Study 125

Primary reviewer will fill out the following required fields in RAC DB for Epic study record creation:

o Study short name from the SRIC form

o Study title from the protocol or ICF

o PI name & PI UFID (in xxxx‐xxxx format)

o Study Coordinator & SC UFID (in xxxx‐xxxx format)

o Billing contact name (in last name comma space first name format), phone and fax number (in 352‐000‐0000 or 352‐000‐0000 x00000 format), email address, and PO Box number.

Obtain (W)IRB Number

IRB01

Upon receipt of the IRB packet, IRB‐01 staff will email the IRB‐01 number to the FLA/secondary reviewer who originally sent the FLA to IRB‐01. The secondary reviewer will add IRB‐01 number into the RAC Database by copy and paste method only to the appropriate record (add “‐H” to the end if it is not already there). Example: 651‐2011‐H. Create a subfolder in the study folder on S drive titled “IRB‐01+IRB#”. Example: IRB‐01 651‐2011‐H. Save the email from IRB‐01 into this subfolder as the source document.



WIRB

Effective from 11/20/2011, the FLA/secondary reviewer will place the RAC# (PS Proposal# or PI UFID as appropriate) on all FLAs. As of (date TBD) the research team will be required to provide the RAC# on their WIRB submission under “Institutional ID” in order for WIRB to accept the submission.

RAC secondary reviewers will look up the WIRB number in the WIRB database or the WIRB report (RAC access to the WIRB database is still pending), and enter the WIRB number into the RAC Database (add “G” to the end if it is not already there) by copy and paste method when possible.

IRB Number Format

IRB Office IRB Number Format Example

IRB‐01 Current

XYYYYH X: sequence# without leading zeros YYYY: 4‐digit year Letter H: study is approved by IRB‐01

7‐2011‐H 27‐2011‐H 207‐2011‐H

Click# Pending – coming soon

IRB‐03

XYYYYJ X: sequence# without leading zeros YYYY: 4‐digit year Letter J: study is approved by IRB‐03

7‐2011‐J 27‐2011‐J 207‐2011‐J

WIRB

YYYYXXXXG XXXX: 4‐digit sequence# (with leading

zeros if necessary) YYYY: 4‐digit year Letter G: study is approved by WIRB

20110007G 20110027G 20110207G

Create Epic Study Code

Secondary reviewers will create the Epic StudyCode based on the IRB# in the RAC database. The StudyCode is a study administrative record identifier in the Epic system and must be unique for each record.

General Epic StudyCode Format

The general format for the Epic Study Code is IRB# with “‐GNV” added to it. See examples below (record #100, #101, and #102).

Study with Multiple Billing Plans

A study (one IRB number) may have multiple protocols with different R99#s or billing plans.

Secondary reviewers will determine if multiple Epic records are required. If yes, secondary reviewer will notify primary reviewers to create multiple records

in RAC database ‐ each with a unique RAC#.



Secondary reviewers will assign unique StudyCode to each record. See examples below (record #103‐107).

Epic Study Record ID

Epic Study Code (W)IRB# Definition

#100 27‐2008‐H‐GNV 27‐2008‐H Study approved by IRB‐01, conducted in Gainesville.

#101 20080045G‐GNV 20080045G Study approved by WIRB, conducted in Gainesville.

#102 27‐2008‐J‐GNV 27‐2008‐J Study approved by IRB‐03, conducted in Gainesville.

#103 20081234G‐GNV‐Aim2 20081234G

Study approved by WIRB; *Aim 2 = second record for the study (second billing plan record) conducted in Gainesville.

#104 20090027G‐GNV‐Healthy 20090027G

Study approved by WIRB. Two protocols “Healthy” and “MRI” with separate R99#s. Both protocols are conducted in Gainesville. #105 20090027G‐GNV‐MRI

#106 27‐2010‐J‐GNV‐Arm1 27‐2010‐J Study approved by IRB‐03, conducting

2 arms in Gainesville. #107 27‐2010‐J‐GNV‐Arm2

Note: We do NOT upload any protocol /arm being conducted in Jacksonville.

2. Epic Study Creation – Automatic Program <Coming Soon> HSC IT is working on a (semi‐)automatic program to create study records in Epic upon IRB approval. The program will pull data from IRB and RAC database…

RAC will review exception/error reports for the Epic automatic study upload program.

Reports under development: PI mismatch in IRB & RAC DB… RAC DB reports ….

<Coming Soon>



3. Create Studies in Epic via Hyperspace RAC may receive Epic study upload requests from research teams through the listserv EpicUPLOADREQUEST‐[email protected]. Upon receiving the request, RAC staff will log into Epic Production Hyperspace and manually create the Epic study record.

RAC Epic Access

Access to Epic Production Hyperspace must be acquired from AHC IT Identity and Access Management. Contact Sharon or Sandra to request Access. A valid Shands ID will be assigned with the Epic security template “RAC User‐ AMB/IP Research Administration Compliance T00190”. This template, available only to RAC staff members, provides the ability to create research studies in Epic.

Study Creation Data Preparation

Before going into Epic to create the study record, check the study record in the RAC Database:

Look up the study in RAC database. Confirm the Epic Upload box is set to ‘Yes’. If Epic upload box is set to “Yes”, confirm all the required data elements are filled out. See Set the Epic Study Upload box section in this document. If data is missing, or to confirm information in the RAC database, you can use the Study Upload Template: S:\DOCOM\RESEARCH ADMIN\Epic\Epic Study Creation via Hyperspace\Study Upload Template.xlsx to request information from the research team.

Confirm the correct IRB number by looking the study up in the IRB‐01 database (see Lynn or Sharon) or WIRB database (see Mary Ellen). Also see Obtain (W)IRB Number section in this document. Note: Eventually we will all have access to these databases so we can look up IRB#s.

Create the Study Code if necessary. See Create Epic Study Code section.

Log In to Epic Production Hyperspace

1) Open your web browser and visit https://citrix.shands.org. Login with your Shands ID using the default Shands domain.

You will be taken to the next screen.



2) Click on the Epic Production –Hyperspace icon and wait until the Epic Hyperspace

login screen appears (there will be a significant delay).

3) Enter your Shands ID and password again, click on the LOG IN button to log in.

4) On the next screen, type in Epic VIEWONLY in the Department field, then click OK.



Verify Study Does Not Already Exist in Epic

You must first verify that the study does not already exist in Epic before you create a new record. Go to the Epic button > Patient Care > Research Study Maintenance.

The study Select screen will appear.

You can search the study by the IRB# or the study short name in the search box.

Search by IRB#: type “irb.” followed by the first few characters of the IRB#, including dashes (e.g., irb.27‐2008).

Search by Study Short Name: type the first few letters of the study short name to

search (e.g., CCTRN).

If the study does not exist in Epic, proceed to create the study record in Epic.



Create a New Study in Epic

1) Go to the Epic button > Patient Care > Research Study Maintenance.

2) The study Select screen will appear. Click on Create.

3) The study Create screen will appear.

ID is the Epic Study Record ID. Write down and/or enter it in RAC database.

4) The study information screen will appear. The Study Short Name you have entered

on the last screen will appear in the Study Name field (field 0) below.

Enter Study Short Name from SRIC here.

This is the Epic Study Record ID. Write it down and/or enter in RAC database. You will need this number later in step 11 and 12.

Click the Accept button to go to the next screen.



At this screen, enter the following:

Study code (field 1): Epic Study Code. See Create Epic Study Code section. Location (field 2): Enter ‘30’. Value will change to UF & Shands Gainesville. Guarantor type (field 3): Epic Guarantor Type. See Set Epic Study Upload

Box section. DB GL comp (field 4): Study R99#. Leave blank if no R99#. ICR GL comp (field 5): RAC Logbook #. IRB approval (field 6): (W)IRB#. See (W)IRB# format in Obtain (W)IRB

Number section. Description (field 7): study long name.

Leave other fields on this screen blank.

5) Verify the Study Code, Location, and Guarantor Type (field 1, 2, and 3). Once the next step is completed, the three fields will not allow updates anymore.

6) Click the Create Patient and Associated Guarantor and Hospital Accounts button on the screen above. A Research Study Maintenance pop up box appears indicating this action will create a patient record and associated guarantor and hospital accounts. Click Yes.

0 1: Epic StudyCode 2: Enter 30 3: Epic Guarantor Type

4: R99# 5: RAC#

6: IRB#

7: Study Title

Caution! Only click this button after you have verified Study Code, Location, and Guarantor Type. Once this button is clicked, the three fields cannot ever be changed/corrected.

The EPIC Study Record ID from step 3 appears here.



.

A Research Study Maintenance pop up box appears indicating the accounts were created successfully. Click OK.

7) A Guarantor Demographics section with contact information fields appears. The

Patient/Guarantor Information section contains Patient and Guarantor account information.

8) In the Status field, change the status from Inactive to Active. Then Click the Next

button.

9) Complete the Guarantor Demographics section:

Contact (field 8): Study billing contact name. Format: last‐name, first‐name

Phone (field 9): Billing contact’s phone number

8: Name 9: Phone 10: Fax

11: Email

12: PO Box

Change to Active



Fax (field 10): Billing contact’s fax number

City (or ZIP) field 11: Billing contact’s email address

Address (field 12): Billing Contact’s PO Box. Format: PO Box 123456.

10) The Research Users screen will appear. Add PI and study coordinator(s) by following the steps in below:

Click on the magnifying glass to pop up the search box.

Enter the name as “LAST, FIRST MI”, (enter a space between the “,” and “FIRST name”) click on the magnifying glass. The search result contains contact information to help you verify that you have the right person. You can search on partial names, but you must start with the first letters of the last name.

11) After PI and study coordinator(s) are added, click the Accept button. The Research Study Maintenance window closes. The study record has been created.

12) Go back to the RAC database, and add the Epic Study Record ID that you obtained from Step 3 to the appropriate study record in the RAC database, if you did not add it at Step 3. Add your initials to the Epic Record Created By box in the database.

13) Be sure to add the study record that you have just created to the Epic Upload tracking file on the S drive: S:\DOCOM\RESEARCH ADMIN\Epic\Epic Study Creation via Hyperspace\Epic Study Creation Tracking.xlsx. You will need the Epic Study Record ID.



14) Email study team that the study has been uploaded to Epic. Below is a sample email template: Dear XXX, A Study Admin Record has been created for your study (IRB#: <Insert IRB#> and short name: <Insert IRB#>) in Epic. Please log in to Epic Hyperspace to verify the study information and start adding participants as appropriate. You are encouraged to visit the RAC website to get more information on Epic study and participant management. Study Admin Record in Epic: http://rac.med.ufl.edu/manage_study/participantregistration/study_in_epic/

Manage Study Participant in Epic: http://rac.med.ufl.edu/manage_study/participantregistration/participant_epic/

RAC Guide to fields in Epic Research Screens: http://media.news.health.ufl.edu/misc/rac/forms/RAC_Handouts/RAC_Guide_to_Fields_in_Epic_Research_Screens.pdf

Please feel free to contact the RAC office if you need additional assistance.

Documents

EPIC Research and RAC - University ... - University of …media.news.health.ufl.edu/misc/rac/rac_internal/RAC_EPIC...EPIC Research and RAC ... (in xxxx‐xxxx format) o Billing contact