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|eIRB Personal Account Questions:
How can I obtain my eIRB username and/or password?
What can I do if I forget my password?
eIRB requires both a Rutgers NetID and eIRB account. All faculty, staff, and students are provided with Rutgers NetIDs.
All eIRB users require a Rutgers NetID account in order to login.
All non-Rutgers users will be required to request a Rutgers Guest Netid.
To do so, please navigate to the following link: https://requests.rutgers.edu/app/ui/#guestrequest
For any questions regarding the Guest Process, please navigate to: https://requests.rutgers.edu/guestsfaq.htm
For any follow up information about your Guest Account request, please contact the helpdesk 848-445-HELP (4357)
I do not work at Rutgers. How do I get an ID so I can use the eIRB system?
What is the role of the Department/ Division Approver?
The role of the Department/ Division Approver is to administratively review and approve the research study as well as the participation of each member listed on a study before it is routed to the IRB Office for review and approval. If a study involves multiple departments, then each Department/ Division chair or designee must issue their approval for the involvement of their department in the study.
Additionally, the Department/Division Approver for the Principal Investigator is attesting that the PI has the qualifications and resources to conduct the study.
(Department/ Division Approvers are the individuals within each department/division who have signatory authority for a department/division.)
eIRB Basic Terminology:
What is a Project?
What is a Workspace?
|"Project" is the generic term for any reviewable item in the eIRB system. Protocols, Modifications/Amendments, Reportable Events, Continuing Reviews, etc. are all examples of projects.
|"Workspace" is the term used to describe various views in the eIRB system. For example, you'll have a personal workspace where you can view all of the projects waiting for your action. Clicking on a project's name then takes you to the project's workspace. Here you will be able to perform actions associated with the project, such as submitting changes, electronically signing it, or opening an attachment.
What is an Activity?
|"Activities" are what you use to perform actions on a specific project. These take the form of colorful "buttons" which are always located on the left side of the page when you are looking at a project's workspace. The activities there will change depending on where the project is in the review process. Click the activity button to open up a small form containing options and instructions for completing the activity.
What is a Form?
What is a State?
|"Forms" are web pages in the eIRB system that have fields on them which allow a user to input information. For example, when you click on an activity button in the eIRB, it opens the activity form. When you create a new project (such as a protocol), you enter information on the project form.
|A "State" refers to the current status of a project. "In Review" or "Awaiting Assignment" are examples of states. You can always see the current state of a project by opening it's workspace and looking in the upper left corner of the page.
What is a Continuing Review?
|"Continuing Review" is a standard term used to describe an annual IRB review - commonly called a "Renewal" in the Rutgers research community. In the eIRB system, there are two types of Continuing Reviews - an annual progress report (Renewal) and a final progress report (Final Report). To create either one of these project types, navigate to the protocol workspace and click the "Create Continuing Review" button on the left side of the page.
What is a Reportable Event?
|A "Reportable Event" is a general term given to a protocol event which is related to items such as Unanticipated Problems, Adverse Events (reportable and non-reportable), Protocol Deviations, DSMB Reports, and Acknowledgement Requests.
What does it mean when my project is in the "Presubmission" state?
|Projects default to the Presubmission state when they are first created. In this state, the project is fully editable by all study staff with edit rights. The study will stay in this state indefinitely until it is submitted for review.
Navigating the eIRB System:
The protocol disappeared - why can I no longer see it?
|In order to make it easier to determine when something requires your action, items will only appear in your inbox when they are specifically waiting for you or a member of your team before they can proceed further. However, you can always view any of your protocols by clicking the "Studies" link located in the dark red page header.
How do I figure out the status of my project?
|The current status of the project is always displayed in the upper left corner of the project's workspace. Additionally, you can see who (if anyone) is currently working on the project by going to the "Studies" link and looking in the "owner" column. It might be useful to contact the current owner if you need more information about the project's status.
I received an email that I needed to do something, but when I log in nothing is there.
|The most common reasons for this problem are:
1) You have multiple personal workspaces and are currently in the wrong one. For example, Department Chairs have a "Department Approver" workspace that shows work associated with that role, and a "Study Staff" workspace that shows any work they might have as a PI, Faculty Sponsor, etc. To change your workspace, click the appropriate link under "My Roles" on the left side of the page.
2) The project in question had a status change after the email was sent. For example, the protocol may have been withdrawn from review, or someone else in your group may have already responded to the notice and completed the work.
Why am I receiving a "-1" error message?
|An error message containing a -1 usually means that whatever action the system was taking timed out before it could complete. This can occur during times when traffic on the Rutgers network is high. Trying the activity again in a few minutes usually resolves the problem.
Please contact eIRB support at firstname.lastname@example.org if you are consistently receiving -1 errors at a particular spot that does not seem related to network traffic.
Performing Actions in the eIRB System:
How do I add study team members not in the pick list?
How do I withdraw my Protocol/Continuing Review/Modification?
|Navigate to the project you wish to withdraw and click on it to open its workspace. Look for an activity button called "Withdraw" under "My Activities" on the left side of the page. If you do not see this activity, it is because a reviewer currently has ownership of the item. Contact the IRB and have them send the item back to you so you can withdraw it.
How do I make and submit changes?
|Whenever the IRB office requests changes your submission, you can enter the changes directly to the project form. This is similar to the process when you initially entered information to create the application. In order to do so: Navigate to the project's workspace, and click on the "View/Edit" button located on the left side of the page. Enter the changes on the form, then use the "save" and "exit" links to save your changes and exit the form. When you are done, use the "Submit Changes" activity button to send the item back to your IRB administrator.
You can check the "Change Log" tab in the project's workspace to see a log of all the changes you've made after initially submitting the project for review.
How do I create a Renewal or Final Report/Study Closure?
How do I create a Protocol Deviation or Reportable Event?
|Navigate to the protocol's workspace for which you need to create the Renewal/Final Report. On the lower left side of the page, click on "Create Continuing Review" and follow the instructions on the Continuing Review form.
|Navigate to the protocol's workspace for which you need to create the Protocol Deviation/Reportable Event. On the lower left side of the page, click on "Create Reportable Event" and follow the instructions on the form.
How do I submit my project for review?
|Click on the "inbox" tab in your study staff workspace to view all projects currently in the "Presubmission" state. Click on the project to open its workspace. Look for an activity labeled "Submit" on the left side of the page.
Questions Regarding Consent Forms and Attachments:
I need to edit an approved consent form, but it's locked.
|If you are creating an amendment which includes consent form updates, use the draft consent forms as your starting point rather than the approved. These are identical to the approved consent forms except for the "stamped" footer. Once the modification request is approved, the new consent form will get a new stamped footer.
Why are the approved consent forms locked?
|In the past when the IRB approved a consent form, a paper copy was generated which received an ink stamp marking it as an IRB approved form. Now that the approved document is electronic rather than paper, it is necessary to put security measures in place to help ensure that the content in an electronically stamped consent form is not altered while still appearing to have a mark of IRB approval.
I can edit parts of the form but have a problem attaching documents.
I receive a “The page cannot be found.” error when trying to open an attachment.
There are two possible causes for this issue:
1) When you first attempt to upload a file, a pop-up may appear asking you “The application’s digital signature has been verified. Do you want to run the application?” Click on the checkbox next to “Always trust content from this publisher” and press the “Run” button.
2) The eIRB attachment component requires a current version of Sun Microsystems Java to be installed on your computer. Update Java at http://www.java.com/en/download/
The file name must have a recognizable extension (e.g. .doc,.txt, .pdf). The file must be renamed on the local computer and attached again.
Word for Macintosh users, please add the .doc extension.
Word 2007/2010 users, please use Save As Word 97 – 2003 to save with the .doc extension (not .docx). This allows reviewers with earlier versions of Word to view the attachment.
Where can I find consent form templates and other university forms?
Is there a way to spell check projects in eIRB?
Yes, it is possible to spell check content submitted using eIRB forms. While eIRB does not include a built-in spell check tool, you can use the spell checking utilities integrated with the various web browsers that the system supports.
Click Commerce recommends the following:
• Internet Explorer — For Internet Explorer 9 and below, you can use a third-party tool called ieSpell. ieSpell is free to download for personal use. If you want to use it for other purposes, you'll need to purchase a commercial license.
Spell Check IE : Answers.Microsoft.com
• Google Chrome or Firefox 3.0 or later — includes a built-in spell check tool. If you install a dictionary, these browsers check spelling inline on all multi-line text area fields. For single-line fields, you can right-click to use the spell check setting. Right-clicking on a mis-spelled word enables you to view spelling suggestions or add a word to the dictionary.
• Safari for Mac — includes a built-in spell check tool. eIRB does not support the Windows version of Safari.
Does eIRB conform to 21 CFR Part 11 guidelines?
|Yes. eIRB's portal level security and product practices provide a system that satisfies 21 CFR Part 11 requirements when used in combination with university standard operating procedures (SOPs). These policies include items such as password protection, secured physical access to server hardware and other IT-related institutional SOPs.
Where can I find additional help, training and guidance?