Pages & Content

Thursday, September 08, 2011

Simple Amendment - e.g. Change of Sponsor

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)

Tuesday, August 16, 2011

How to load documents to uTRAC while using the Application Portal

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

Friday, July 15, 2011

How does EPIC Handle Research Patients Enrolled in Multiple Studies

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.

Tuesday, June 21, 2011

Did you know…what negative quanity in ePay means?

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.

Friday, April 08, 2011

New Amendment in uTRAC - Did You Know?

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.

Wednesday, April 06, 2011

Great ClinicalTrails.gov Decision Tool



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