Eirbpre-Review and Sign

eIRBPre-review and Sign

- Step by Step -

version: 19 March 2015

This new process was instituted in the eIRB to enable a group of PIs to work together on their protocol during the DRAFT stage. Many activities occur here, including initiating,editing, reviewing, and e-signing the human studies protocol (which the a-tune software refers to as a document). It is also the stage for attaching other documents like ICFs, surveys, and training evidence at the file level.

The group should email one another as the protocol develops. When satisfied, the PI is the last one to e-sign. That signifies the group is done and the protocol moves to the IRB office for administrative review. Of course, during admin and IRB member review steps, the PI group will have the opportunity to revise whatever is necessary.

Step 1:

-When the PI creates a new protocol, the PI name is automatically entered into sections 1 and 3 below.

-VERY IMPORTANT: the PI has to assign his or her co-PIs manually in sections 2 and 3 in order to give them access to the protocol. Then, they all can do the drafting steps (reviewing, attaching, signing, etc.).

Step 2:

-The PI sends the protocol to co-PI(s). To do this, the PI sets the status “Pre-Review & Sign” by right clicking on the draft version of the protocolas shown. It is recommended to entera comment of explanation, too.

-All PIs assigned in section 3 above will receive a notification email from the system.

Step3:

-The co-PIopens the protocol (1, below).

-Then, s/he clicks on “Review” (2).

-And,leaves any review comments for the PI to consider and apply (3).

-During all of this, the protocol is still in the status of “Review & Sign”. See the column labeled “Document status”.

Step 4:

-When the co-PI(s) have finished entering comments, each needs to e-signthe protocol. This signifies everything is ok. Alternativley, it can be a signal that another review by the co-PI is needed – it would be good to e-mail that to the PI.

-To e-sign, select the option “e-signatures (to provide)” as shown at (1) below.

-E-signing steps:

The signature popup window opens (2).

All PIse-sign the protocol as displayed“required signature that are needed” (2c)

The PI entershis/her Bronco password in the field at 2a.

And click on “Sign” (2b).

The PI name should move from section 2c to section 2d.

All other Co-PIs need to repeat the steps 3 and 4 as needed.

Step 5: The PI should be the last person to e-sign the protocol. This is however a suggestion. The group of PIs needs to work out the strategy for editing and being satisfied that the protocol is ready to go to the IRB for review.

When ready:

-The PI checks-out the protocol (1) to have editing control.

-The green check is displayed, meaning that the PI can edit the protocol (2).

-The PIlooks for “Review” comments made by the co-PI(s) (3).

-And, the PI makesany modifications to the protocol using the appropriate “tab”at the left for which comments have been entered (4).

Step 6:

-The PI e-signs the protocol (1).

-If the PI is the last one to sign, the protocol will move automatically to the next status which is “To IRB office, Admin. Review” (2).

Step 6:

Congratulations! You’ve finished the initial draft and submitted it for IRB review.

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