UMClinicalStudies - How to Add a New Study

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Add a new Study

Please note the following before posting a study:

Allowable Information

The UMClinicalStudies website is designed to post basic information for IRB-approved research studies. Although you can write your posting at any time, postings can only become active (visible to others) after your study has received IRB approval. OHRP and FDA guidelines state that, unlike advertisements, these basic postings do not require IRB review separate from initial or ongoing IRB approval. This guidance helps allow UMClinicalStudies to be a useful, fast, and streamlined resource. However, in order to be considered a 'basic posting', the posting MUST NOT contain certain types of information.

Your posting MUST NOT promise benefits from participating. Your posting MUST NOT discuss the risks of participating. Benefit and risk are complex issues that need to be discussed during an informed consent procedure. The study posting should only provide basic information so that interested persons can contact the study team for further information. If you discuss risks or benefits, or use language that may suggest a risk or benefit (like 'treatment' or 'cure'), the system will give you a warning. You may be contacted and asked to change your posting or your posting may be deactivated.

Posting Accuracy

Any study posting that is visible to the public (active) must accurately display current study information. The UMClinicalStudies study posting must also be synchronized with any other active internet posting pertaining to the same study. For example, a study has a brief description posted on its department's home page. This same study's UMClinicalStudies posting should reflect that same description. Changes made in either place should be synchronized so that the two descriptions are always the same. In addition, internet study postings should be kept current.

It is also important to note that UMClinicalStudies.org is linked with the UMHS consumer website, UofMHealth.org. When patients and the general public search the UofMHealth.org website, their searches will also produce results for studies that are entered into UMClinicalStudies.org. Because consumers will be able to directly click on the link provided that is associated with their search, it is critical that study titles are short and easy to understand, and that a lay description is provided to clearly describe the study details that would be relevant to a participant. By including "tags" or "key words", you will ensure that the appropriate studies are matched to each search. Instructions on how to do this are noted below.

Instructions:

Select "My Studies" under Researchers and login with your Kerberos / Level 1 uniqname and password.
Click on "Add New Study" button.
Read the consent and select "Accept" if you agree with it.
Enter the IRB number of the study you wish to add.
If the study has an IRB number starting with 'HUM', you will be directed to go to eResearch to add the study to UMClinicalStudies. Why?. (If the study has a legacy IRB number - starting with a year like '2004-', please click here for instructions.)
Read the instructions and click the "Gotchya!Take me to my study in eResearch" link.
A new window should open that shows you the eResearch study workspace for the study that you are trying to add. You need to have access right to the IRB application in eResearch to add a study to UMClinicalStudies.org.
Click on 'Edit Study' link under 'Activities' in the left hand column.
In question 8-2.6 or 5-3.10 (Exempt applications only), check the box next to Posting on www.UMClinicalStudies.org. If this box is already checked, skip to step 11. . Postings become active when the UMClinicalStudies.org box in section 8-2.6 is selected and IRB approval is granted. Once your study is active, it can be viewed by potential volunteers, and matched to registered volunteers that have similar eligibility criteria. You can then manage your volunteers and contact them through the www.UMClinicalStudies.org website.
If you have an already approved study, an Amendment will need to be submitted to change your answer to this question. The 'Edit Website Posting' link in step 12 will only appear when the Amendment is approved.
Please Note:
- Changes to the posting information can be completed via the Edit Website Posting Data activity at any time the activity is available.
- The following information is being pulled from other parts of the study in eResearch for the Website Study Posting: study title, study ID, the department associated with the study, the PI's last name, the minimum and maximum ages of participants, compensation, Minority Health Research Program approval, MCRU approval and Cancer Center approval numbers.
Complete rest of the study application if need be and then Save and Exit the application.
Click Edit Website Posting
Enter the information in the fields and complete the form.
Note:
- Posting Activation Date indicates when the study should be posted to the website.
- Posting End Date indicates when the study should be removed from the website.
- A study must be approved by the IRB before it can be posted on the website.
Click OK
You are done editing the fields that re relevant to the UMClinicalStudies website posting. Once your application is submitted and approved, you will have access to the UMClinicalStudies website posting content for edits and recruitment.
Note:
It takes about 24 hours before the posting shows up on UMClinicalStudies if the following conditions are satisfied:
- The study is approved.
- The current date is between the study approval and expiration date.
- The study checked that they would be using UMClinicalStudies for marketing purposes in Question 8-2.6 or 5-3.10 (for Exempt applications only).
- The current date is between the UMClinicalStudies 'Posting activation date' and 'Posting end date'.

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Still need help?

If you need help with UMClinicalStudies, please email us or contact us at 1-877-536-4243. Thank you!