Forms

eResearch

New Project Application

Use the new project application in eResearch for both standard applications and exemption requests. See our Education web-page for workshops on eResearch. For web-posted instructions on eResearch, see IRBMED guidance.

1. Click on the New Project Application link which will take you to the eResearch homepage.
2. To start an application click on the "Log-in" button in the left column.
3. On the next screen, click the "New Study" button in the left column under the Create header.
4. An application opens. Complete the questions on each page. Click the "Continue" button to both save input information and advance forward in the application. This button appears on both the top and bottom of the right side of the screen.
5. Using the "continue" button will invoke 'smart form' logic which will route you to only those sections of the applications you are required to complete.
6. If you 'jump' to different sections of the application your information will be saved but you risk completing sections that are not required.
7. When the application is complete the principal investigator must hit the 'submit' button in the homespace of the application.

Previously Approved Projects

When submitting the renewal application it is helpful to check if the informed consent template has been changed in a manner that impacts your study. See IRBMED News.

1. Click on the eResearch link which will take you to the eResearch homepage.
2. Click on the "Log-in" button in the left column.
3. On the next screen, click the "Approved Studies" tab in the center of the page.
4. Click on the link (i.e., the title) of the particular study you need to amend, renew, terminate, or for which you need to submit an adverse event or ORIO (other reportable information or occurences).
5. Click on the option in the Function tab in the left lower column
6. Use "New Continuing Review" to renew or terminate the study, as appropriate.

Emergency Use Report

Use the new project application in eResearch (see instructions in "New Project" above), indicating in section 1.12 whether the report is for use of an investigational drug or device. IRBMED recommends both calling and emailing the office as soon as the decision to use an investigational agent for clinical purposes is made. After hours and on weekends, in addition to emailing the office, ask the UMHS operator (734-936-4000) to page the IRBMED chair on-call.

Humanitarian Use Device Application

Use the new project application in eResearch after reviewing the Humanitarian Use Device Guidance to determine which type of application you should submit..

eResearch Package Cover Sheet

Use this cover sheet when submitting three-dimensional objects to the IRB Office that are associated with a particular eResearch submission. For example, complete the cover sheet when submitting a DVD with a movie for subjects that was too large to upload into the on-line form. Click here for a sample.

Patient Release Form

Recruitment Advertising Flyer Templates

Researchers are NOT required to use these templates. They are offered as an example of the type of flyer typically approved. You may change the fonts, colors, add logos, artwork, etc. Do not make monetary compensation a larger font than the expected risks.

These templates include the header for 'watermarking' in eResearch. The flyer must be saved and uploaded into eResearch as a .DOC to enable the watermarking function.

• 8-1/2 x 11 Flyer
• 11 x 8-1/2 Flyer

Page updated 8/16/2012