uTRAC Knowledge Base

Simple Amendment - e.g. Change of Sponsor

noreply@blogger.com (uTRAC Tips and Tricks) — Thu, 08 Sep 2011 16:07:00 +0000

From the start up page of the study application click “New Amendment” this will take you to the Clinical Trial Amendment page.

Check the “Administrative Changes” box and type a brief explanation in the “Comment” field and select “OK”. This will take you to the first page of the Basic Information section. From the “Jump To” menu located in the grey navigation bar just below the red logo bar. Select “Study Sponsor” out of the drop down list.

If you are changing the Primary Sponsor you may clear the field by selecting “Clear” in the text field begin to enter the sponsor – a search drop down will appear, you may select the sponsor from this list. If the sponsor does not appear in the list you may submit a request to have the sponsor added to the database (submit request to utrac-support@umail.utah.edu).

Save and Exit – you are now on the Draft Amendment page from here select the down arrow in the “My Activities” bar. Select “Approve Amendment” In the Approve Amendment window there should be no other items to be approved and since the only change was to the Sponsor leave the Check Box unchecked. Select “OK”

You will now be at the Historical Revision level to navigate back to the start up page use the “bread crumb” links in the grey navigation bar just below the gold menu bar (click on the study name)

How to load documents to uTRAC while using the Application Portal

noreply@blogger.com (uTRAC Tips and Tricks) — Tue, 16 Aug 2011 15:55:00 +0000

First you need to create a "New Folder" and have it located in the right area and add the files you want to up load uTRAC – here is how.

Open Windows Explore
Select > OS (C: )
Create a ‘New Folder’ (Name it something to help you find it later)

Load all the files you are going to upload to uTRAC into this folder

To test:
Logon to the Application Portal
Double click on ‘My Documents’
Click ‘Folders’ located in second menu from the top left of screen
When prompted - Select ‘Full Access’
Scroll down to ‘C$ on 'Client' and click on it.

When it expands you should be able to see files located on your computer’s OS (C: ) drive look for the ‘New Folder’ you created previously and loaded all the documents in.

From uTRAC ‘Attachment’ page
Select ‘ Browse’ on the line item you would like to upload a document to.
From the ‘Choose File’ selection window – select ‘My Computer’ (on left side of selection window)

When prompted - Select ‘Full Access’ > OK
Scroll down to ‘C$ on 'Client' and click on it.

When it expands you should be able to see files located on your computer’s OS (C: ) drive look for the ‘New Folder’ you created previously and loaded all the documents in.

Click to open and select the file you want to upload

How does EPIC Handle Research Patients Enrolled in Multiple Studies

noreply@blogger.com (uTRAC Tips and Tricks) — Fri, 15 Jul 2011 17:31:00 +0000

Did you know that if patients are enrolled in more than one study, and two or more of the studies clear their charges in the same EPIC WQ, that patient’s charges will fall into the WQ only once for review. You are able to determine if a patient is enrolled in more than one study by looking under the “Line Count” column located within the WQ. If one or more of your patients is enrolled in more than one study, please follow these directions:

1) If you don’t know what other studies the patient is enrolled in, open the patient’s charge session, click on the “Jump To” tab, and select “Registration.” Go to the “Documents” section to see what other study cohort boxes display for the patient. If you do not recognize the PI listed in the cohort name and cannot determine if the other study’s charges fall into the same WQ, please contact Summer Davis (summer.davis@hsc.utah.edu; 801-213-3606) before proceeding to resubmit the charges.

2) If you know that the other study clears charges for the patient in another WQ, please proceed to resubmit the charge for the patient as you normally would. However, if you know that the other study clears charges in the same WQ, continue to step three.

3) Instead of resubmitting the charge out of your WQ, please click on the “Accept” tab within the charge session, log a comment stating that the charge is unrelated to your study (include your IRB# or PI in the comment), and then click the “Accept” button WITHOUT checking the “resubmit” box.

4) Once you leave the charge session, highlight the session you just reviewed, and look for your comment located in the charge session’s history. If there are no other comments, leave the charge in your WQ for the other team/teams to review. However, if you see that the other study team/teams have already logged a similar comment stating they have reviewed the charge, go ahead and resubmit the charge session from you WQ.

Did you know…what negative quanity in ePay means?

noreply@blogger.com (uTRAC Tips and Tricks) — Tue, 21 Jun 2011 19:47:00 +0000

A negative quantity on an ePay in uTRAC represents a charge correction from Epic? The initial billing error has to be approved as a positive quantity, post CRCE review and approval, following the export to PeopleSoft a negative quantity will be sent and require approval to balance the study account.

uTRAC Workflow of Stages

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 08 Jun 2011 21:58:00 +0000

New Amendment in uTRAC - Did You Know?

noreply@blogger.com (uTRAC Tips and Tricks) — Fri, 08 Apr 2011 17:14:00 +0000

New Amendment in uTRAC

From the study level

1. Click on 'Amendment' tab (lower middle of screen)

2. Click on 'New Amendment' button (left side menu)

3. Identify what type of amendment you are creating

4. Write a description

5. Click 'continue'

If you are not planning on editing the PBG/budget then click 'continue'

In order to create a cohort amendment:

From the 'Project Amendment' level)

1. Click 'My Activities'

2. Select 'Create Amendment'

Re-name the new cohort and click 'ok'
To change a specific section of the PBG click on 'SmartForms' drop down and then choose the form you would like to amend.

Follow the same directions used to insert procedures on the PBG:

1. Click 'Add'

2. Enter and select applicable CPT code

3. Choose the 'billing-code'

4. If study billing is the billing code and your study has multiple sponsors identify who is paying/ If the study has a single sponsor then it will automatically bill that sponsor. This is what will change your budget and might require your review.

5. Identify the quantity and when the procedure is being completed.

6. Press 'Continue' if you have other aspects of your PBG (visit schedule, ARUP-billable, personnel, non-billable/non-personnel or any of the pricing pages) please refer to the Draft User Guide.

Choose the applicable 'POS' Place of Service and press 'Continue' or 'Exit', the PBG if complete, after clicking 'Save'.

Continue creating the amendment by using your 'Continue' button or selecting a 'SmartForm' page in the 'Jump To' menu. If you are complete with the amendment click 'Exit'.

If you are not planning on editing your budget then click 'Continue', chances are if you change the study PBG your costs/budget will change. Otherwise click "Continue'.

After the amendment is complete click 'My Activities' and choose "Approve Amendment', then click 'Ok' to finalize changes.

Now the study has a historical revision logged in the history log file located in the 'History' tab toward the middle of screen. The History logs all activity made on the study application. Click on the 'Study Name' (in the upper left under the logo) this is called a breadcrumb and allows you to move back to previously accessed pages. Back on the home page of the study you now may start to enter participants in the 'Active' study state.

Great ClinicalTrails.gov Decision Tool

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 06 Apr 2011 15:00:00 +0000

Shared with us by:

Tonya K. Edvalson, BS, CIP, CCRP

Manager, Research Compliance - Obstetrics and Gynecology Research Network

Manager, Woman and Child Institute

IRB Coordinator - National Children's Study

Exemption for uTRAC

noreply@blogger.com (uTRAC Tips and Tricks) — Tue, 29 Mar 2011 01:49:00 +0000

All clinical research studies are required to use uTRAC. A study is clinical if it involves one or more prospective clinical procedures, services, or other items. By institutional policy, no exceptions can be made to this rule. If you have been directed to open a uTRAC application and you feel the study may qualify for an exemption read on.

Exemptions are applicable to health-related studies that include no prospective clinical items. Such studies are limited to:

a. retrospective chart review
b. registry or survey of health information
c. data coordinating centers
d. clinical research studies that have completed all study participant visits.

To self-certify for an exemption, answer the following questions:

1. Is your study survey, chart review or data entry only?: Yes or No
a. If yes, uTRAC is probably not required. Continue to question 2.
b. If no, uTRAC may be required. Continue to question 2.

2. Does your study involve any prospective clinical items? Yes or No
a. If yes, uTRAC is required unless all visits have been completed. Continue to question 3.
b. If no, uTRAC is not required.

3. Has the study permanently ended all study visits/clinical items? Yes or No
a. If yes, uTRAC is not required.
b. If no, uTRAC is required (see training schedule in right column and refer to the front page for instruction on how to request an account)

If you feel the study qualifies for an exemption download the uTRAC Exemption form and contact the office of Clinical Research Compliance and Education 801-213-3601

The quick guide to creating a uTRAC application

noreply@blogger.com (uTRAC Tips and Tricks) — Tue, 29 Mar 2011 01:33:00 +0000

Goal: assist the user in creating a uTRAC application without background information. For detailed information about each section refer to the uTRAC user guide manual

1. To create a study click “New Clinical Trial”
2. To access an already existing clinical trial’s home page click on the name
3. To access a specific SmartForm (page in the application) click the drop down arrow next to “SmartForm” and choose the page on the applicable trial.

If creating a new clinical trial then you will see the first page of the application, you cannot continue on to the rest of the application until the page has been saved.

Red asterisks are required fields throughout the application. Help text appears on the right hand side to aid your response.

1. Enter page information. Your Financial Analyst (FA) could be “unassigned”, yourself or another appropriate individual who oversees the study finances. Note: For someone to view the study they will need to be added to the study’s contacts.(Base Information Page 1)
2. Press “save”
OR
3. Press “continue”, save and continue to save the information entered on the pages.

Click Image to View

Add or Remove Contacts (ePay Reviewers, etc.) - This is How

noreply@blogger.com (uTRAC Tips and Tricks) — Mon, 28 Mar 2011 22:26:00 +0000

Add or Remove Contacts

To add contacts or ePay Reviewers; the individuals you choose to be the reviewers will need to take the ePay Reviewer Training (check the training column on the right side of our website www.medicine.utah.edu/crce for trainings) after they complete the training they are granted an ePay Reviewer user role in uTRAC.

Then you will need to add them to the study's contact list – you may do this in one of two ways; if the study is in an editable state you may go to Basic Information Page 1 and add them as a contact on question 7.0. If the study is in the Awarded or Active state then you may go to the dashboard (first page after accessing the study) and go to ‘My Activities’ and look for 'Add or Remove Contacts'

Note: Contacts will need uTRAC user accounts to be able to edit or approve applications.

Link to IRB (ERICA) - Did You Know?

noreply@blogger.com (uTRAC Tips and Tricks) — Fri, 25 Mar 2011 19:08:00 +0000

That prospective clinical research is required to be in uTRAC and a link to the IRB application needs to be linked to the uTRAC application before the IRB pre-board review or before you can enroll participants. If you already have an approved ERICA application you will need to attach your uTRAC application through an amendment or continuing review. Create an uTRAC application and please follow the directions below to link.

For new ERICA applications: log into ERICA > go to section 5.1 . select the applicable study design(s): at least 'prospective clinical research' and click 'save' > go to the uTRAC Application page (from Jump To Menu in ERICA) and attach the existing uTRAC application.

For previously approved ERICA applications: log into ERICA> create an amendment/continuing review > go to the 'edit/modify application' button > make sure section 5.1 is correct and at least 'prospective clinical research' is checked and click 'save' > go to the uTRAC Application Page (from Jump To Menu in ERICA), and attach the existing uTRAC application.

www.research.utah.edu/irb

FYI: The information from ERICA is update nightly to uTRAC

Awarded to Active - Did you Know?

noreply@blogger.com (uTRAC Tips and Tricks) — Fri, 25 Mar 2011 18:57:00 +0000

...that the move from 'Awarded' to "Active' takes only a moment?

>From 'Awarded' under 'My Activities' select 'Activate Proposal'
>From the 'Activate Proposal' pop up window under 'My Activities' select 'Edit Award Information'
>From 'Edit Award Information'

If you do not have a Sponsor Award ID enter 'N/A'
Enter your study account number (chartfield/GL) and select 'Validate Chartfield'

Upon validation, select 'Ok' - the study moves to 'Active'

Validate an MRN - Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Fri, 25 Mar 2011 18:51:00 +0000

In uTRAC you only have to validate an MRN, for a research participant if the research study information is going to be exported to EPIC? If the study data is not exported to EPIC then an MRN is not required to validate allowing the complete entry of participant information without it.

To move the study from 'Awarded to "Active' a question is asked if the study should be exported to EPIC, if there are any billable items then exporting to EPIC is required. If all research procedures are being completed by study effort (facility cost cannot be performed by effort) then utilizing EPIC is not needed and participant tracking is currently optional in uTRAC.

Best and fastest way to acquire prices in uTRAC - copy an existing study

noreply@blogger.com (uTRAC Tips and Tricks) — Tue, 22 Mar 2011 15:20:00 +0000

If you aren't going to be opening a new study in uTRAC soon, then the best and fastest way to acquire pricing would be to make a copy of an existing study - here is how....

Go into an existing uTRAC application.
Under “My Activities,” pick “Make a Copy”
Save the copy as a template, not as a new study.
The template will be housed under the Template menu.
Anytime you need pricing, you can use the template (remember that you need to select Save or Continue to save the page):

Under the Sponsors page, Add 4 different sponsor types (1- primaryand 3 co-sponsors) to a llow for obtaining different prices: Industry (e.g. Johnsons and Johnson), Foundation (e.g. foundation), Federal (e.g. NIH), Institution (e.g. University of Utah
Under the Contact and Title (of Basic Information page 1), last question, put in
how many years you expect the study to be. This will give you the inflation factor.
If you need ARUP pricing: under the Descriptions and Services (of Basic Information
page 2), question 7.0 (near the bottom), make sure that you select ARUP as an ancillary
service - this will bring up the ARUP PBGs 3.1.1 & 4.1.1
to minimize the amount of data that needs to be enter into the template application go
to the Description and Services (Basic Information page 2) question 8.0 should be
marked "No" participant will not be billed then save or continue.
Go into the Protocol Billing Grid page.
Under the SmartForms menu, select any of the PBGs 4.1 through 4.3 (ARUP PBG is 4.1.1)
You may now enter CPT codes to acquire the pricing

Note: ARUP pricing - Enter ARUP 00xxxxx ( x = number). In many cases, you can
also enter a description (e.g. CBC), but be careful for multiple tests with similar
descriptions.

Turning the Template into a project:

If after you create the template and you find that you need to turn it into a study
project you may copy the template and rename it the project name. This will preserve
the original template and give you all the information you previsouly entered.

Note: http://www.aruplab.com/ is a great resource to locate the ARUP codes for labs

uTRAC Update - Epay now Exporting to PeopleSoft

noreply@blogger.com (uTRAC Tips and Tricks) — Thu, 10 Mar 2011 20:11:00 +0000

Updates
1. Study ePAYs are now exporting to PeopleSoft daily, which means your ePAY charges are now being debited from your study accounts.

2. In order for ePAYs to upload to PeopleSoft, uTRAC requires that chartfield activation and expiration dates be entered at time of study activation in uTRAC. Please review your uTRAC studies to ensure this critical piece of information is in place. For existing activated studies that do not contain activation or expiration dates, study teams will need to edit the study uTRAC award information. Following are instruction for doing so:

   a. From the “My Activities” bar, select the “Update Proposal Award Information” activity.

   b. Select the “Edit Award Information” activity from the Project Budget’s “My Activities” drop-down menu.

   c. To Add or Edit the Activation/Expiration date, press the “Edit” button next to the chartfield.

   d. After the date(s) have been updated, press “OK” and then press the “Validate Chartfield” activity.

Generate Visit Schedule & PBG Billables - Reminder

noreply@blogger.com (uTRAC Tips and Tricks) — Thu, 10 Mar 2011 20:10:00 +0000

Reminders
1. When enrolling a participant into uTRAC, please make sure to generate a visit schedule. This prompts uTRAC to effectively upload the participants to EPIC.
2. Participant information will not upload to EPIC if the associated PBG does not contain a billable item in PBG (s) 3.1/4.1 or 3.1.1/4.1.1.

EPIC Price & uTRAC Price - Question & Answer

noreply@blogger.com (uTRAC Tips and Tricks) — Thu, 10 Mar 2011 17:13:00 +0000

Q - Is the 'Epic List' price supposed to be the same as the price given in uTRAC?.

A - Epic maintains the master list price. uTRAC maintains the research charge master. Epic sends uTRAC the list price and uTRAC completes the adjustment; list price minus the net (research) price is the adjustment. Your study account will pay the net (research) price.

New Amendment - Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 23:36:00 +0000

If your study is in the Awarded or Active states & information changes you may open a 'New Amendment' - here is what you do:

1. Click on the 'Amendment' tab (in middle) or the 'New Amendment' button (left side)
2. Identify what type of amendment you are creating (i.e. PGB), write a description, continue

On the 'Project PBG Amendment' level select 'My Activities', select 'Create Amendment' re-name the new cohort and click 'Ok'

To change a specific section of the PBG click on 'SmartForms' from the drop down menu and select the PBG you want to edit (follow the same instructions used to insert procedures on the PBG). Conitue creating the amendment by using 'Conitue' or selecting the 'SmartForms' or 'Jump to Menu' when you are complete click 'Exit'.

After the amendment is complete (from the Historic Amendment level) select 'My Activities' and choose 'Approve Amendment' then click 'Ok" to finalize the amendment.

RSH: Charge Hold (WQ 1843) in EPIC

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 23:22:00 +0000

RSH: Charge Hold (WQ 1843) in EPIC is the WQ that holds all charges listed as “research: yes” in the Research/Transplant field. These charges are held for a maximum of 3 days to give study teams time to enroll their unanticipated new study patients into uTRAC.

When to Validate MRN - Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 21:52:00 +0000

You must validate an MRN in uTRAC’s participant enrollment function ONLY IF your study requires upload to EPIC. The upload to EPIC is required institutionally only when the study includes clinical services that must be billed through EPIC.

The EPIC upload is also required by the CCTS for all studies except “space- only” studies. If you do not need EPIC upload, you may enroll participants without using them MRN. You may also indicate exemption from EPIC upload in uTRAC’s Awarded state before adding the GL (general ledger) number assigned to the study. Note also that, apart from CCTS requirements, studies that include no EPIC billables have been exempted temporarily from participant tracking. Voluntary tracking is recommend.

How to Link ERICA and uTRAC Applications - Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 21:35:00 +0000

...if your study includes any clinical items, you must link your uTRAC and ERICA applications (while the ERICA application is in an 'Open' state). You cannot enroll patients in uTRAC until the link is made. Here is what to do:
1. Create an application in uTRAC
2. If the ERICA application is uneditable, create a quick amendment. The IRB understands the need for the link and does not need much information from you.
3. While the ERICA application is editable, go to section 5.1, choose 'prospective clinical research' and click 'save'
4. Go to the 'uTRAC Application' page (in ERICA) from the jump-to menu and 'select' the correct uTRAC application
5. Double check in uTRAC that the link has occurred before having the PI submit the amendment

Activating Study Proposal - Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 21:25:00 +0000

When activating your study proposal from the ‘Awarded’ state; the export to EPIC question is very import. If ‘no’ is selected, and study related charges occur then the precautions /flags set in place to a avoid inaccurate billing will not occur in EPIC.
Review the information on the page for accuracy. Your study should not be exported to EPIC if you do not have any billable procedures; instead the study staff is performing all procedures by effort (facility and professional).
1. Click SmartForm dropdown arrow next to “My Activities”
2. Select “Edit Award Information”
3. Enter study ID numbers, use N/A if no related number exist and validate the General Ledger number(s)
4. Press ‘OK’ button to identified budget has awarded and to activate proposal

Then repeat steps 1 through 4 above if multiple budgets are present

uTRAC Vist Log - Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 21:07:00 +0000

A Visit Log needs to be created in uTRAC after each study visit takes place. This satisfies the patient tracking requirement in uTRAC.

EPIC to associate patient – Did You Know

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 20:43:00 +0000

In order for EPIC to associate a patient to study and route charges to research WQ, the patient must be enrolled into uTRAC, not just screened: on the Cohort Assignment page, question 1.0 must be filled in, “yes” needs to be selected on question 2.0, and a study cohort box must be selected. Even if randomization has not occurred yet, you will want to select a cohort to the patient before that is it takes place if you want charges to be tagged are research review. If the cohort assignment can be changed after randomization.

Research check box EPIC - Did You Know…

noreply@blogger.com (uTRAC Tips and Tricks) — Wed, 09 Mar 2011 20:34:00 +0000

… Which box to check in EPIC for study visits?
1. Usually, you will only need to check one box for study visit: a study cohort box located under the “Documents and Add’ l” section. The checking of this box alerts EPIC to direct the charges to be billed to either the study or patient, based off of the study’s PBG.

2. You should never check the “Research / Transplant” box, located under the “ Visit Info” section, UNLESS there is no study cohort box available to check (which will only happen if the patient has not been properly enrolled into uTRAC). The checking that the “Research/Transplant” DOES NOT route charges to the correct research WQ, nor does it direct charges to be billed based off a PBG. The only thing checking the “Research /Transplant” box will do, is it will hold charges for a maximum of three days to allow study teams to enrolled their new patients into uTRAC and then to go back and check the study cohort box for the appointment in EPIC.