Completeness checklist review –Tips Sheet
1. Where is the completeness checklist located?
The IRB Administrator will upload the completeness checklist on the “Submission Activity” page of the
HS ERA Application for each initial protocol scheduled for convened review. (Click on the eyeglasses)
2. Why should the members review the checklist?
The intension for the checklist is to provide the Chair and the primary/secondary reviewers with all
administrative changes prior to the start of their review so the members can concentrate on the content
of the protocol for their review. The checklist gives a thorough snapshot of the protocol; it will identify
administrative issues across all study documents that will help streamline the member review. The
Chair and the primary/secondary reviewers are required to utilize the checklist as a review tool at the
beginning of the review process so it is clear what administrative issues have already been raised by the
IRB Administrative staff. (This is to avoid unnecessary duplicative work.)
3. What information does the checklist contain?
The checklist mirrors the HS ERA Application. Each question or checkbox in the HS ERA Application is
reflected on the checklist in the order in which it appears in the HS ERA Application. There is a
“General” section that details basic information about the protocol submission. There is a consent form
and HIPAA Authorization section that details the required elements of consent and HIPAA.
4. Where are the Administrative Stipulations located?
The administrative stipulations will be listed in the “Meeting Agenda” and in the “Addendum” that is
uploaded with the completeness checklist. All members should be familiar with the administrative
stipulations as these issues will be included in the meeting vote for the protocol.
5. Contacting the PI/study team prior to the meeting with concerns.
Note that the IRB Administrative Staff will be in contact with the PI/study team during the IRB
Administrative completeness checklist review with any questions that will require additional rationale.
To help streamline the communication process and avoid duplicative efforts; members should email the
IRB Administrator with any questions, concerns, clarifications, etc. for the PI/study team. The IRB
Administrator will appropriately update the Chair, primary and secondary reviewers with the
supplemental information from the PI/study team. Additionally, these email communications will be
documented on the “Submission Activity” page of the HS ERA application.
Take Home Points:

Become familiar with the completeness checklist document and the IRB Administrative review
process.

Know the administrative stipulations identified by the IRB administrative staff before you begin
your review. This will avoid unnecessary duplicative work and you can concentrate your review
efforts solely on the content of the protocol.

Contact your IRB Administrator with any issues or concerns that need to be addressed by the
PI/study team to streamline the communication between the IRB and the PI.