iRIS Navigation
ADD A NEW STUDY APPLICATION:https://iris.uth.tmc.edu/
- Log in using yourUTassigned用户ID和密码
- ClickADD A NEW STUDYon the top of the left hand navigation bar.
- Enter the requested information on each screen.
- ClickSAVE AND CONTINUEon the top of the right hand side to save entriesFOR EACH PANEL
- In the last panel, clickAGREEorDISSAGREEon theSTATEMENT OF THE INVESTIGATOR.
- ClickSAVE AND CONTINUE
- FollowROUTING PROCEDURESdescribed below
COMPLETE THE SUBMISSION PACKET:
- ClickTHE GREEN TEXT BOXon theIRBSUBMISSION COMMENTS to add information for the IRB reviewers-(This is optional)
- ClickTHE GREEN BOXIn theINFORMED CONSENTsection
- Click ADD DOCUMENT
- Make the appropriate selection to add from a list or upload an existing document
- Click NEXT SCREEN
- Complete TITLE, VERSION DATE, VERSION NUMBER, LANGUAGE
- Click, UPLOAD YOUR CONSENT DOCUMENT
- Browse to locate the document for upload (Microsoft Word, RTF or PDF file only)
- Once the file is uploaded, click SAVE CONSENT
- In the next screen, click SAVE ATTACHMENTS (make sure box is checked next to consent you wish to attach)
- ClickTHE GREEN BOXin theREVIEW BOARD FORMSsection to complete and attach HIPAA forms, MEMORIAL HERMANN HOSPITAL APPLICATION, etc.
- Click ADD NEW FORM for the appropriate form(s)
- Complete the form(s) and SAVE
- Click SAVE ATTACHMENTS (make sure box is checked next to consent you wish to attach)
- ClickTHE GREEN BOXon theSTUDY DOCUMENTSto upload and attach the protocol, investigator’s brochure, copies of case report forms, etc.
- Click ADD NEW DOCUMENT or ADD MULTIPLE DOCUMENTS
- Complete TITLE, VERSION DATE, VERSION NUMBER, CATEGORY
- Click, UPLOAD
- Browse to locate the document for upload (Microsoft Word, RTF or PDF file only)
- Once the file is uploaded, click SAVE
- In the next screen, click SAVE ATTACHMENTS (make sure box is checked next to consent you wish to attach)
- Click theSAVE FORMon the top of the right hand side.
- IF complete,SIGNOFF AND SUBMIT
CONTINUING REVIEW:
- Log in using yourUTassigned用户ID和密码
- ClickMy Studiesin the left hand navigation pane to view your list of studies
- Click on the study for which continuing review is due
- Within the study’s screen, click onCONTINUING REVIEW FORM
- In the continuing review screen, clickADD NEW FORM
- Complete each panel and click,SAVE & CONTINUE
- In the last panel, clickSIGNOFF AND SUBMIT
- FollowROUTING PROCEDURES
CHANGE REQUEST AND AMENDMENT:
- Log in using yourUTassigned用户ID和密码
- ClickMy Studiesin the left hand navigation pane to view your list of studies
- Click on the study for which you would like to create a change request
- Within the study’s screen, click onCHANGE REQUESTS AND AMENDMENTS
- In the change request screen, clickADD NEW FORM
- Complete information in each screen, clicking,SAVE & CONTINUEto next section after each screen is complete.
- In the last panel, clickSIGNOFF AND SUBMIT
- FollowROUTING PROCEDURES
PERSONNEL CHANGE REQUEST:
- Log in using yourUTassigned用户ID和密码
- ClickMy Studiesin the left hand navigation pane to view your list of studies
- Click on the study for which you would like to create a change request
- Within the study’s screen, click onPERSONNEL CHANGE REQUEST FORM
- In the next screen, clickADD NEW FORM
- Complete the screens, clickingSAVE & CONTINUEafter completing each screen
- In the last panel, clickSIGNOFF AND SUBMIT
- FollowROUTING PROCEDURES
RETURN TO HOME PAGE:
- Once you navigate away from the home page, to return HOME
- Click theHOMEbutton in the upper right, clicking home on the navigation link, or
- ClickBACKbutton on the upper right part of the screen until you reach the home page. Do not click back arrow on the browser.
ROUTING PROCEDURES:
Once you have reached the end of a submission and clicked,SIGNOFF AND SUBMIT,you will be presented with a screen that says,“Does this submission require additional routing for approval?”
- ClickYes or NO
- If you selectNO, clickSAVE & CONTINUE
- APPROVE or DENYsubmission and enterUT IDandPASSWORD
- ClickSAVE SIGNOFF
- If you selectYES, clickSAVE & CONTINUE
- SelectKEY STUDY PERSONNELby putting check marks next to persons to include in signoff
- ClickSAVE & CONTINUE
- In the next screen, you may selectADDITIONAL PERSONNELfor routing and signoff by clickingADD SIGNOFF
- Enter the person’s name and clickFIND.The LDAP system will pull up appropriate names,CHECK THE SELECT BOXnext to the correct name and clickSELECT USER
- In the next screen, use thePULL DOWN MENUwhich appears under the name toSELECT A ROLEfor this person.
- ClickSAVE & CONTINUE
- You will have one more opportunity in this screen to add/remove KEY STUDY PERSONNEL and/or ADDITIONAL PERSONNEL – click appropriate option in the left hand column or select YES or NO to indicate whether you have completed your selections
- ClickSAVE & CONTINUE
- APPROVEorDENYsubmission and enterUT IDandPASSWORD
- ClickSAVE SIGNOFF
*Schematic representationof routing instructions
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 Support713-500-7960 |
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CLINICAL TRIALS RESOURCE CENTEROFFICE OF RESEARCHENVIRONMENTAL HEALTH & SAFETY |
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