The Radiology Research Services System (RRSS)

Transcription

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

2 Contents The Radiology Research System Overview...2 Creating a REDCap Account...4 Accessing the Radiology Research Services System in REDCap Protocol Review...5 Radiology Research Imaging Needs Identified Survey...6 Site Survey/Scanner Qualification Requests Study Initiation Activities Radiology Research Approval Notification Survey Study Procedures Request Information Forms Research Study Uploading Request Forms Answering Queries Requesting Radiologist Reads Study Closeout Activities Radiology Research Services System: User Handbook 1

3 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. Radiology Research Services System: User Handbook 2

4 Study Life Cycle + RRSS 1 Protocol Reviews 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. 2 Study Initiation Activities 3. RR receives IRB approval notification & approves study. 4. RR sends SC Radiology Research Approval Notification survey. 3 Study Procedures 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. RR = Radiology Research SC = Study Coordinator 4 Study Closeout Activities 8. RR receives IRB notification and closes study. Radiology Research Services System: User Handbook 3

5 Creating a REDCap Account You will need REDCap to access the Radiology Research Services System. To create an account: 1. Visit 2. Enter your KUMC username and password. 3. Follow the prompts to create an account. 4. Check your KUMC and click on the link in the 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.

6 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 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 notification (see below) to complete a survey. Radiology Research Services System: User Handbook 5

7 Radiology Research Imaging Needs Identified Survey After clicking the link in your , 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 section will expand if Yes is chosen to enter a different PI name. This section will expand if Sponsor, Grant, or Other is chosen to enter the sponsor or grant name. This person will receive an 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). Radiology Research Services System: User Handbook 6

8 The date entered here generates a calendar invite to radiologyresearch@kumc.edu. If the date changes, us. These fields and some fields below will differ based on the needs identified in the protocol. 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. radiologyresearch@kumc.edu if you have special training needs. Be sure to complete ALL required fields and then click Submit. You and radiologyresearch@kumc.edu will receive confirmation of your submission. Radiology Research Services System: User Handbook 7

9 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: 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 radiologyresearch@kumc.edu will receive a notification of your submission. Radiology Research Services System: User Handbook 8

10 After radiology has completed the request, you will receive the following 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. Radiology Research Services System: User Handbook 9

11 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. Radiology Research Services System: User Handbook 10

12 2. Study Initiation Activities Radiology Research Approval Notification Survey After the study is IRB and radiology approved, the study coordinator will receive the below. You should click on one of the links in the to complete the brief survey. After clicking on the link in your , the survey below will appear. Simply click on the submit button to document you received the activation notification. Radiology Research Services System: User Handbook 11

13 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. Radiology Research Services System: User Handbook 12

14 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. REDCap automatically generates the Study ID. You can think of this as a REDCap record number. Enter your name and . Attach your upload request to the correct study from the dropdown list. Click Save and Go To Next Form to complete your request. Radiology Research Services System: User Handbook 13

15 The Research Study Uploading Request Form If the uploading request is for a scan that was completed in the past, enter the past scan date. 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, 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. 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. 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. Radiology Research Services System: User Handbook 14

16 Radiology research will receive notification of your request and you will receive an confirmation of your request. After your request has been completed, you will receive the following confirmation . 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. Radiology Research Services System: User Handbook 15

17 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. Radiology Research Services System: User Handbook 16

18 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 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. Radiology Research Services System: User Handbook 17