eirb review guide for committee members version 01/05/2015 1

eIRB Review Guide For Committee Members

Version 01/05/2015

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Accessing the eIRB• Follow the link below:

https://compliance.csupomona.edu/tickatlab/default.aspxOR

• Find the link through the IRB website at: http://www.csupomona.edu/~research/irb/index.shtml

OR• Follow the link that will be included in the email sent to you

from tick@lab [this is under development in January 2015]

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Locating the PI’s ProtocolThere are 3 possible places that the PI may place the protocol.

1. Uploaded as an attachment to the file (not applicable for protocols submitted after 01/05/15)

2. Manually entered into the eIRB form

3. ???????????????????????

If the protocol was entered using option number 1, you will (should) find the label (Word Doc.) next to the protocol’s title.

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NOTE, please!Some examples of screens will not look the same because of editing

being done in the eIRB.

The Main Menu Pageclick on Files & Documents

(note: your screen will only show those protocols you are actively involved with; this screen shows the view of a sys administrator)

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NOTE, please!Files are like the whole folder. Inside are documents like the

protocol, ICFs, surveys, etc. Document and protocol are

equivalent. All other “documents” attach to the file.

Option 1: Protocol was uploaded to the file levelAfter you’ve entered Files & Docs, this page will show up. But note that only protocols you are

involved with will show up on your screen. Locate the protocol you are reviewing. Do not enter the protocol yet. Locate the paperclip to the left of the title of the protocol. The paperclip will be

the actual protocol document. So, RIGHT click on the paperclip.

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RIGHT clicking the paperclip should bring up a menu. Choose Edit Attachment. (which means opening and editing the protocol document)

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After choosing Edit Attachment, this pop up will appear. The protocol will be here,

possibly with the ICF and survey as separate attachments as well.

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Posting Comments: Now that you have read the protocol, you are ready to leave your review.Return to the main page that lists the protocols.

Find the protocol you are reviewing and LEFT click on it to open it.

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The protocol does not open up completely just yet, but instead you are taken to this screen where a purple and a blue bar appear.

Hover over the protocol title under the blue bar and LEFT click twice.

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The next screen should look like this (below). Click on the Review button to post your comments.

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The pop-up seen below should appear. On the left side, choose the select the subject

about which you would like to make a comment. Then hit the Start New Topic button.

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After you have typed your comments into the purple box, change the bottom (??) menu option (red circle at right).

When done, hit the Publish button in the middle. This saves the comment as well. When completely done, close the window and exit the protocol and the eIRB.

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Option 2. Protocol has been manually entered into the eIRB form LEFT click on the protocol from the menu.

Notice that “(Word Doc.)” does not appear next to the title.

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Once the file is open, LEFT click twice over the protocol/document to open it.

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Now that it is open, go through each section using the menu on the left hand side.After you read each section, you can leave comments.

To do that, follow the same steps as mentioned before (see slides 11-12, start new topic).

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To find the supporting documents that go along with the protocol, go back to the main menu and RIGHT click on the paperclip next to the protocol’s title (in the purple bar). (Attachments are attached at the file level now; not at the document/protocol level.)

Choose Edit attachment.

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When you are done . . .• When you are satisfied that you have made all the comments you want, there is one

last step. • Go back to the menu by hitting the Back button.

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RIGHT click over the section titled IRBP Document Status (under the blue bar).This should bring up a menu.

Choose the option IRBCO ADMINISTRATIVE REVIEW.From here, the administrative reviewer will send the protocol for the PI for

revisions.

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After the PI has responded to your commentsYou will receive an email informing you that the PI has responded to your comments. You will need to log back into the eIRB and Review their responses.Then decide if they are satisfactory to you and if the protocol can be approved.

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Choose the “All” button at the top to see all the comments. Click on each of your comments to bring up the PI’s response.

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Below is how it will look: your comment and their response right below.

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Be sure to review the updated documents• Besides changes to the protocol, the PI will likely have re-uploaded other revised

attached “documents.” If so, you will need to locate them and review them. They will be uploaded in the manner which was discussed earlier.

• If the protocol was entered manually, the changes which the PI made will be in RED or BOLD in the document.

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When you are completely satisfied with the protocol

Instead of sending the protocol back to the PI for revisions (which you may do as much as needed), choose the option of IRBCO ADMINISTRATIVE REVIEW. Then, email the IRB administrative reviewer to inform him/her that the protocol is ready to be approved by the chair. [Technically, in expedited review with DIR (designated IRB member), you are approving. The chair’s role is to acknowledge the approval and that all appropriate review and approval steps have occurred.]

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That’s it!

You are now ready to complete a review using the eIRB!Please contact one of us if you have any questions.

CONGRATZ.

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NOTE, please!These instructions need critical friends feedback, too. Please

offer your suggestions.