Clinical trials have helped us to discover new treatments that make our lives better. Consider making an impact on health care by participating in a clinical trial.
We are fortunate to count on so many giving-hearted supporters, and we want to share some of their stories with you. We want to show you the courage, the determination, and the generosity of spirit that define their journeys with UTHealth Houston.
We are fortunate to count on so many giving-hearted supporters, and we want to share some of their stories with you. We want to show you the courage, the determination, and the generosity of spirit that define their journeys with UTHealth Houston.
Log in using your UT assigned User ID and Password
Click ADD A NEW STUDY on the top of the left hand navigation bar.
Enter the requested information on each screen.
Click SAVE AND CONTINUE on the top of the right hand side to save entries FOR EACH PANEL
In the last panel, click AGREE or DISSAGREE on the STATEMENT OF THE INVESTIGATOR.
Click SAVE AND CONTINUE
Follow ROUTING PROCEDURES described below
COMPLETE THE SUBMISSION PACKET:
Click THE GREEN TEXT BOX on the IRBSUBMISSION COMMENTS to add information for the IRB reviewers- (This is optional)
Click THE GREEN BOX In the INFORMED CONSENT section
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)
Click THE GREEN BOX in the REVIEW BOARD FORMS section 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)
Click THE GREEN BOX on the STUDY DOCUMENTS to 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 the SAVE FORM on the top of the right hand side.
IF complete, SIGNOFF AND SUBMIT
CONTINUING REVIEW:
Log in using your UT assigned User ID and Password
Click My Studies in 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 on CONTINUING REVIEW FORM
In the continuing review screen, click ADD NEW FORM
Complete each panel and click, SAVE & CONTINUE
In the last panel, click SIGNOFF AND SUBMIT
Follow ROUTING PROCEDURES
CHANGE REQUEST AND AMENDMENT:
Log in using your UT assigned User ID and Password
Click My Studies in 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 on CHANGE REQUESTS AND AMENDMENTS
In the change request screen, click ADD NEW FORM
Complete information in each screen, clicking, SAVE & CONTINUE to next section after each screen is complete.
In the last panel, click SIGNOFF AND SUBMIT
Follow ROUTING PROCEDURES
PERSONNEL CHANGE REQUEST:
Log in using your UT assigned User ID and Password
Click My Studies in 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 on PERSONNEL CHANGE REQUEST FORM
In the next screen, click ADD NEW FORM
Complete the screens, clicking SAVE & CONTINUE after completing each screen
In the last panel, click SIGNOFF AND SUBMIT
Follow ROUTING PROCEDURES
RETURN TO HOME PAGE:
Once you navigate away from the home page, to return HOME
Click the HOME button in the upper right, clicking home on the navigation link, or
Click BACK button 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?”
Click Yes or NO
If you select NO, click SAVE & CONTINUE
APPROVE or DENY submission and enter UT ID and PASSWORD
Click SAVE SIGNOFF
If you select YES, click SAVE & CONTINUE
Select KEY STUDY PERSONNEL by putting check marks next to persons to include in signoff
Click SAVE & CONTINUE
In the next screen, you may select ADDITIONAL PERSONNEL for routing and signoff by clicking ADD SIGNOFF
Enter the person’s name and click FIND. The LDAP system will pull up appropriate names, CHECK THE SELECT BOX next to the correct name and click SELECT USER
In the next screen, use the PULL DOWN MENU which appears under the name to SELECT A ROLE for this person.
Click SAVE & 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
Click SAVE & CONTINUE
APPROVE or DENY submission and enter UT ID and PASSWORD
