eIRB Pre-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.).
Be sure to save!
1
2
3
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 protocol as shown. It is recommended to enter a
comment of explanation, too.
- All PIs assigned in section 3 above will receive a notification email from the system.
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Left click on the file to
obtain the versions of the
document/protocol below
Right click on the
protocol for this drop
down menu
Step 3:
-
The co-PI opens 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”.
1
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2
3
There is a save button at the
bottom of this screen!
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.
1
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- E-signing steps:
 The signature popup window opens (2).
 All PIs e-sign the protocol as displayed “required signature that are needed” (2c)
 The PI enters his/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.
2
2a
2b
2c
2d
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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 PI looks for “Review” comments made by the co-PI(s) (3).
- And, the PI makes any modifications to the protocol using the appropriate “tab” at the left
for which comments have been entered (4).
1
2
3
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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).
1
2
Step 6:
Congratulations! You’ve finished the initial draft and submitted it for IRB review.
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