The Radiology Research Services System (RRSS)...2017/06/17  · Radiology Research Services System:...

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University of Kansas Medical Center The Radiology Research Services System (RRSS) User Handbook 1/20/2016

Transcript of The Radiology Research Services System (RRSS)...2017/06/17  · Radiology Research Services System:...

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University of Kansas Medical Center

The Radiology Research Services System (RRSS) User Handbook

1/20/2016

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Radiology Research Services System: User Handbook 1

Contents

The Radiology Research System Overview .................................................................................................................2

Creating a REDCap Account ........................................................................................................................................4

Accessing the Radiology Research Services System in REDCap .................................................................................4

1. Protocol Review ......................................................................................................................................................5

Radiology Research Imaging Needs Identified Survey ...........................................................................................6

Site Survey/Scanner Qualification Requests ..........................................................................................................8

2. Study Initiation Activities ..................................................................................................................................... 11

Radiology Research Approval Notification Survey .............................................................................................. 11

3. Study Procedures ................................................................................................................................................. 12

Request Information Forms................................................................................................................................. 12

Research Study Uploading Request Forms .......................................................................................................... 14

Answering Queries .............................................................................................................................................. 15

Requesting Radiologist Reads ............................................................................................................................. 17

Study Closeout Activities ......................................................................................................................................... 17

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Radiology Research Services System: User Handbook 2

The Radiology Research System (RRSS) Overview The Research Division within the Department of Radiology provides specialized imaging services for research

studies conducted at The University of Kansas Medical Center and other affiliated locations. These services

include, but are not limited to: study protocol review, site survey/scanner qualification completion, corelab

image uploading, specialized radiology reads, and specialized PET/CT scanning.

In order to more effectively support the growing need of these requests, the Radiology Research Team has

created a secure, centralized REDCap database to house all requests and send notifications. The system is

designed as an integrated two-part database to incorporate information at both the study and patient levels to

efficiently track, service, and bill for ancillary research services in the Radiology Department.

Involvement of study coordinators in this process is summarized as follows:

Protocol Reviews

1. Radiology research administrators will send a survey link to study coordinators for completion.

2. Study coordinators will open the survey link, fill in data fields, and submit the survey to document/confirm radiology needs for the clinical research study. Radiology research administrators will be notified of survey completion.

3. Radiology research administers will notify the study coordinator when the study has been approved.

Image Uploading and Special PET/CT Requests

1. Study coordinators will complete request forms by using the Radiology Research Services System REDCap database.

2. Radiology research administrators will be notified of the requests, confirm them, and notify study coordinators when the service has been completed.

3. Documented information will then be exported to support billing operations.

4. Study coordinators will be able to answer all queries from corelabs using the REDcap database.

Site Survey/Scanner Qualification Requests

1. Study coordinators will use a survey (link found on our website) to submit site survey requests.

2. Radiology research administrators will be notified of requests, complete the request, and notify study coordinators.

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Study Life Cycle + RRSS

Protocol Reviews

1

Study Initiation Activities

2

Study Procedures

3

Study Closeout Activities

4

1. RR reviews protocol for imaging & special research procedures. 2. RR sends SC “Radiology Research Imaging Needs Identified” survey.

A. SCs submit Site Survey/Scanner Qualification Request, if necessary. B. RR completes request & notifies SC.

3. RR receives IRB approval notification & approves study. 4. RR sends SC “Radiology Research Approval Notification” survey.

5. SC uses REDCap to request uploads & answer queries. SC uses O2 to request special reads.

6. RR completes upload/reads & notifies SC. 7. RR bills studies for services.

8. RR receives IRB notification and closes study.

RR = Radiology Research SC = Study Coordinator

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Creating a REDCap Account You will need REDCap to access the Radiology Research Services System. To create an account:

1. Visit https://redcap.kumc.edu/

2. Enter your KUMC username and password.

3. Follow the prompts to create an account.

4. Check your KUMC email and click on the link in the email to verify your REDCap account

Accessing the Radiology Research Services System in REDCap After logging into REDCap, you will see your homepage. Click on the “My Projects” tab.

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A listing of all projects to which you have access will appear. The Radiology Research Services System projects

are titled “1.2 Radiology Research Services Requests”and “1.3 Radiology Site Survey/Scanner Qualification

Requests.” If you do not see these links in your “My Projects” tab, you have not been given access to them.

Please email [email protected] for access.

1. Protocol Review When the radiology team has reviewed a protocol and determined radiology services may be involved, project

directors or study coordinators will receive an email notification (see below) to complete a survey.

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Radiology Research Imaging Needs Identified Survey After clicking the link in your email, the survey will appear. You cannot save a partially-completed survey to

revisit later, so you will need to complete the survey in one sitting.

This person will receive an

email notifying him/her of

this designation (if different

than the person filling the

survey) and will receive all

subsequent system

generated notifications

(along with the person filling

this survey).

This section will expand if

“Sponsor,” “Grant,” or

“Other” is chosen to enter

the sponsor or grant name.

This section will expand if

“Yes” is chosen to enter a

different PI name.

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Email

[email protected]

if you have special training

needs.

Be sure to complete ALL

required fields and then click

“Submit.” You and

[email protected]

will receive confirmation of

your submission.

These fields and some fields

below will differ based on the

needs identified in the

protocol.

The date entered here

generates a calendar invite to

[email protected].

If the date changes, email us.

This section will expand if

“Yes” is chosen to enter

comments.

A link to the “Site

Survey/Scanner Qualification

Request” survey will appear

“Yes” is chosen.

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Site Survey/Scanner Qualification Request If a site survey or scanner qualification request is necessary, you can find link to this survey on our website:

http://www.kumc.edu/school-of-medicine/diagnostic-radiology/radiology-research/research-

administration.html.

Since you cannot save a partially completed survey, the survey must be completed in one sitting.

Be to complete ALL required

fields and click “Submit.” You

and

[email protected]

will receive a notification of

your submission.

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After radiology has completed the request, you will receive the following email:

REDCap holds records of all site survey/scanner qualification requests and completions for reference in the

event of queries. To look up records, find the “1.3 Radiology Site Surveys/Scanner Qualification Requests” link in

your REDCap list. Click on any of the visible forms on the left to view your upload request and completion

records. The “Site Survey/Scanner Qualification Request Completion (Rad Research)” form will be most helpful

to answering queries. If you know the record number of the request, choose it from the dropdown box.

Otherwise, you can search by study name, sponsor name, or other identifier in the Data Search box.

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In this instance, you can see information from Idea32 study record from the “Site Survey/Scanner Qualification

Request Completion (Rad Research)” form. Since you have view only access, you may print this screen or

download the confirmation document for your records, but you cannot change any of the information.

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2. Study Initiation Activities

Radiology Research Approval Notification Survey After the study is IRB and radiology approved, the study coordinator will receive the email below. You should

click on one of the links in the email to complete the brief survey.

After clicking on the link in your email, the survey below will appear. Simply click on the “submit” button to

document you received the activation notification.

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3. Study Procedures

The Request Information Form After a study has been approved, study coordinators will enter patient data and request radiology services in

REDCap. (See the section on “Creating a REDCap Account” for more information on opening an account.)

1. Click on the “1.2 Radiology Research Services Requests” link from the “My Projects” tab.

2. Click on the “Request Information” link.

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3. You will see the screen below. To add a new record, click the “Add New Record” button.

4. The following screen appears. Complete the fields as appropriate.

Enter your name and email.

REDCap automatically

generates the Study ID. You

can think of this as a REDCap

record number.

Click “Save and Go To Next

Form” to complete your

request.

“Attach” your upload request

to the correct study from the

dropdown list.

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The Research Study Uploading Request Form

If you have filled as much info into

the data fields as possible, choose

complete. Choose incomplete or

unverified if you would like to

come back later to fill missing data

fields. (This form need not be

marked complete for the request

to be submitted to Radiology

Research.)

If the uploading

request is for a scan

that was completed

in the past, enter the

past scan date.

If the uploading

request is for a scan

that was completed

in the past, you can

enter today’s date if

you need the scan

ASAP. However, it

will take Radiology

Research up to 3-5

business days to

complete the

request.

Click “Save Record” to save your

request and return to the form’s

homepage. If the form is marked

“complete,” your request will be

sent to Radiology Research when

you click the “Save” button. If the

form is marked “Incomplete” or

“Unverified,” the request will NOT

be sent to Radiology Research.

If you ever need to go back

to the previous form to fix

or view something, you

can click on the form’s link

here. If you have completed as much

data into the data fields as possible,

choose “Complete.” When you click

the “Save” button below, your

request will be submitted to

Radiology Research if this form is

marked “Complete.” Choose

“Incomplete” or “Unverified” if you

would like to come back later to fill

in missing data or verify data. When

you choose either save options

below, your request will NOT be

submitted.

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Radiology research will receive notification of your request and you will receive an email confirmation of your

request. After your request has been completed, you will receive the following confirmation email.

Answering Queries REDCap holds records of all upload requests and completions for reference in the event of queries. To look up

records, find the “1.2 Radiology Research Services Requests” link in your REDCap list. Click on any of the visible

forms on the left to view your upload request and completion records. The “Research Study Uploading Request

Completion (Rad Research)” will be most helpful to you in answering queries. If you know the record number of

the request, chose it from the dropdown box. Otherwise, you can search by patient name, MRN, or other

identifier in the Data Search box.

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In this instance, you can see Dr. Seuss’ upload record from the “Research Study Uploading Request Completion

Rad Research)” form. Since you have view only access, you may print this screen or download the confirmation

document for your records, but you cannot change any of the information.

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Requesting Special Radiologist Reads When special radiologist reads or scan parameters are necessary, please inform radiologists and technologists

via O2 imaging orders, NOT REDCap. If special imaging or reads are necessary for this study patient, in the

“additional clinical indications” field, enter **Research: [insert instructions] to flag patient (300 character

limit). The text entered in the “additional clinical indications field” will translate to the technologist details

report, control sheet, and radiologist reading palette.

If imaging and reads are performed as standard of care (SOC), DO NOT ENTER any special comments. If you do

not know what to do, please email [email protected] for help. Please DO NOT simply enter

information in the field.

4. Study Closeout Activities Radiology receives notification from the IRB and closes the study.