Electronic Application (eIRB)
How to Submit a New Protocol Using the eIRB System
All applications for review are submitted using the Velos and eIRB Systems.
Note: Access to UT Southwestern Medical Center's internal research systems (eIRB; Velos) requires an active UT Southwestern Login ID.
If you do not have an active UT Southwestern-issued Login ID, then you will need to obtain one. You will need to contact an administrator in the department of your UT Southwestern sponsor to assist you by first completing the Request to Add a New Person (Not Recruited) form in PeopleSoft, followed by an IAR (Institutional Access Request) form through Information Resources. Each form type requires a minimum of 24 work hours to process.
The eIRB system is designed for online submissions of human subject research protocols, using a web browser. Protocols submitted in eIRB are routed and reviewed electronically. Notification of study approval is sent via email.
Request Access to eResearch
Requesting user access to eResearch requires a valid active UT Southwestern ID, Parkland Health & Hospital System ID, or Children’s Healthâ„ ID. Please click on the link below for instructions on requesting access authorization to eResearch.
Registering the Study in Velos
Velos is a study management tool and is the first step to submitting your Protocol through the eIRB System.
|1.||From the Login screen, type the following information in the corresponding fields:
Then click Login
Note: If you have an earlier version of Internet Explorer 6.0, press the Control key while clicking the Login button. An error screen will display. Press Control and click OK again
|2.||From the Homepage click Manage Protocols from the left navigation toolbar.
|3.||The Velos required fields on the Summary page should include:
|4.||Enter your e-Signature in the e-Signature field (default is “1234”) and click Submit|
Changing the Study Status
When a new study is registered in Velos, the study is assigned a default status of “Not Active.” This indicates that the study is still in a draft state. Once you are ready to send the information to eIRB, you must add a new status of “IRB – Submission Initiated” to trigger the transmission of information from Velos to eIRB. Follow these steps to add or edit a study status in Velos.
|1.||From the Summary page, click the Study Status tab|
|2.||Click Add a New Status|
|3.||Select the Organization, Status Type, IRB|
|4.||Select Study Status of Submission Initiated|
|5.||Select today’s date|
|6.||Enter your e-Signature in the e-Signature field (default is “1234”) and click Submit
Your study has now been sent to eIRB
Completing the eIRB Application
Log into eIRB
- Type your User Name and Password in the corresponding fields. (These will be the same as your UTSW User Name and Password)
- Click Login
- In the right top corner, click My Home
- In the My Home workspace, click the Studies Tab
- Click on the Study Name
If you have several studies you can enter study search criteria such as: Study No., Name, or State, and press Go.
Study Activities you can perform will display on the left:
- Click Edit Study to complete the Smart Form (Note: Use Continue function when completing the form.)
- Click Finish at the end of the application.
- Click to Validate Smartform once you have completed the Smart Form application, and clear any errors that are displayed.
- Click Notify Co-I Regarding Participation if the study has co-investigators listed in item 1.5. The system will send a notice for each Co-Investigator named in the application to follow the link provided and click Approve Participation. All named Co-I’s must approve their participation to move forward with the submission. If a study doesn’t have any co-I’s listed, skip this step.
- Once these steps are completed, only the PI will be able to Submit the study for approval. (Note: Request for Pre-Review activity is currently not available and should not be used.)
Once submitted by the PI, if a study has a Faculty Sponsor listed, the study will be routed to the Faculty Sponsor for approval, and then it will be routed to the Faculty Sponsor’s Department Chair for approval. If a study does not have a Faculty Sponsor listed, the study will be routed directly to the PI’s Department Chair for approval.
If a study application indicated involvement of 1) cancer patients, their caregivers or relatives, 2) cancer prevention, or 3) assessing cancer epidemiologic, imaging or biological markers for early detection or risk stratification, the study would be simultaneously routed to the Department Chair and the Protocol Review and Monitoring Committee (PRMC).
Once approved at the department level (and by PRMC, if applicable), your study will be sent to the IRB.
Please refer to the Study Creation tip sheet for more information.
Training for eIRB can be requested from Academic Information Systems (AIS) trainers by submitting a request to firstname.lastname@example.org.