June 2021 iRIS IRB Updates Adding Study Personnel
1. Click Setup Study Personnel
2. Enter in a first name and last name.
3. Click Find User/Search Directory
4. Before adding the individual, click on the person icon to check if they have current Human Subjects and HIPAA Research training.
5. If they have current training, click on the green arrow under the column Select.
6. You must now select the role for each person you add to the study. You can designate them as a PI, Additional Investigator, Research Support Staff, Study Contact, or Designated Department Reviewer (SSMR/Department Chair).
7. Once you have selected the role, click Save in the bottom right corner. You will repeat these steps for each person added to the study.
8. You can view your study personnel by scrolling through the bottom of the screen. If you need to remove someone, you can click the red X next to their name. Once you are finished with adding personnel, you will click Close Setup of Study Personnel in the bottom right corner.
Study Personnel Pools
You are now able to create pre-defined study personnel groups to add across multiple submissions—iRIS calls these pools. Pools are useful for teams that have the same individuals for multiple studies.
For this to work, you will add all your study personnel to the study you are currently working on. If that study team will be replicated for multiple studies, you will save that combination of individuals as a Study Personnel Pool.
Things to note. Pools are not made available to every user listed in them. For example, if I create a group, other users in the group will not be able to see it.
Groups can only be edited within an application but groups created on other studies can be added to any future study.
1. Click Create My Personnel Pool
2. You can assign a name to each group that you create. To review your pool, you can scroll through the bottom of the screen. You will have the ability to edit any of your groups; however, you can only edit the groups by adding or removing someone from the study you are currently working on. This will change the group for future use (not on existing studies). Click Save once you are finished reviewing. This pool can be added to any future study.
3. The screen shot below shows what a new study would like if you are adding a group that was created previously. You can choose to Select All or you can choose to add specific people from your pool.
You can update, create, or delete your pools using the menu bar on the left.
Uploading Documents
You can now drag and drop documents into iRIS to add them to your study. Any time you click on Add a New Document, you will see a screen like below to upload the document. If you do not wish to drag and drop the document, you can click on the box to browse your desktop.
When uploading a new document, you will want to add a category to each document you upload. Document categories is not a new function, but this will affect some of the document management functions of this new build.
Document Management
Checking documents in and out, adding existing documents, and creating new versions of existing documents have changed in this new build.
Checking Documents In and Out
1. In your submission form (e.g. amendment, continuing review), click on Select/Revise Existing.
2. Click on Create a Revision next to the document you want to revise.
3. Click Check Out Document.
4. Your document will download at the bottom of your screen. You can open it from that link, or you can browse your desktop for your edited document.
Once you’ve made changes to the document, you will click on Check In Document from this page to upload the revised version. If you need to cancel this revision you can select Undo Check Out Document. This reverts the document back to the previous version number.
Adding a New Document
When you add a new document, you will be prompted with a new set of questions. These questions are meant to ensure that the document you are adding is actually a new document rather than a revision to a previously uploaded document. This process will aid in cleaning up your document storage in iRIS.
1. Click Add a New Document
2. Select the category that applies to your document.
3. If you have more than one document already listed in that category, for example a protocol, iRIS will ask you if this document is a revised version of this document. If this is a new version of an existing document, you will select that document and click Process with Document Upload. If this is an entirely new document, you will click on I want to add a new document that has not been uploaded for this study. This second selection will take you to the document upload screen.
4. After you selected the version 1.0 of the protocol, you will be prompted with a document upload screen. You will notice that this upload screen has already updated your document to version 1.1.
5. This process allows your documents to be housed in the same protocol folder for you to easily see the most current document. This prevents your Other Study Documents and Informed Consent folders from having multiple documents of the same type to exist throughout the life of the study.
Editing Documents in Browser—Stipulations Required
If your document was returned to you with stipulations, you have the ability to revise the document as described above but you also have the ability to edit the document in the browser window. This is helpful for those that need to make quick simple changes. Swapping out language, removing text, etc. This is not useful to edit graphics or to revise documents that have multiple graphs, charts, images, etc. Editing in the browser window could disrupt formatting of the document.
Study Submissions Status Panel
A new panel exists on the researcher home page. This panel is called Study Submissions Status. This panel shows the current status of the individual submissions in the pipeline.
This panel shows where the submission is in the review pipeline, the routing list, and the submission history. This panel allows the researcher to retract a submission, to modify the routing list, respond to stipulations, and sign off on a submission.
1. To see all the details, click on Steps, then click on the plus sign in the first column to see details.
2. If your submission is in the IRB queue, more of the workflow is shown in the details. Note: Pre-Review means that this submission is in the IRB queue and Post-Review means that it has been assigned to someone (not necessarily a chair/vice chair).
Routing a Submission for SSMR/Department Chair Signoff
1. Once you are prepared to submit your study for SSMR/Department Chair review, you will click on Signoff and Submit. Then you will click on Go back to make changes. This will take you to the page to add your SSMR/Department Chair.
2. Click on Add Additional Personnel to the Routing List. If you added your SSMR/Department Chair signoffs to the personnel section of the application, they should automatically pull to this section.
3. Search for the person. Click on the green arrow next to their name to add them. Add their role. Click on Save Add to Routing List.
4. Once you have added your SSMR/Department Chair, you will click on Save-Start Signoff Routing.
