Basic iRIS instruction
Study Submission in iRIS
Log in to iRIS using your UTHealth user ID and password. Click on Study Assistant link on the right of the screen and choose Add a New Study. Choose IRB application. Complete the IRB application. The IRB application is a smart form and questions will appear based on the answers you choose. When you have completed the application, you will be directed to the Submission Packet screen. Attach the appropriate documents in this panel:
Informed Consent
- Informed Consent
- Any other handouts or material that will be given to participant to assist with the consent process
Review Board Forms
- Memorial Hermann Research Application (if the research involves Memorial Hermann Hospital system data or facilities)
Study Documents
- Protocol
- PI and Co-I CVs (attaching the CVs in the user's profile is preferred. Once it is uploaded in the profile, you will not have to attach the CV for each new submission.
- Case Report Forms (Or data collection forms. Please combine the pages or sections of the data collection form or case report form into one PDF before attaching)
- Recruitment flyers or advertisements
- Investigator brochures (if applicable)
- Correspondence with the FDA (for clinical investigations initiated by a sponsor investigator)
- Letters of approval from other institutions involved in the research (e.g., HISD, Other IRB approvals, etc.)
- Diagnostic Imaging Review and Approval Form (if research involves diagnostic imaging procedures)
- Pathology Review and Approval form (if research involves specimens from Pathology)
When you have attached all the documents, click Signoff and Submit. You will be directed to a panel that lists names of study personnel. Check the boxes next to the names of all the co-investigators so that the application packet is routed to them for signature and COI disclosure. When everyone has signed off, the application will be sent to the CPHS queue. You may check the status of the application at anytime by checking Workflow Tracking.
Tips for Successful IRB Submission
Detailed: Entering a Protocol in iRIS
Detailed: Responding to a Returned Submission
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
|
Committee for the Protection of Human Subjects IRIS Support 713-500-7960 |
|
|
|
CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
||
