COEUS

Title Line

Frequently asked questions

What is Coeus eIRB?

Coeus, named after the Greek Titan of Intelligence, is an electronic research administration system. After receiving a grant from the National Center for Research Resources in 2002, Yale played a lead role in developing the IRB module with a consortium of institutions and the Massachusetts Institute of Technology (MIT) which served as the lead technical developer. The Yale IRBs have used Coeus for tracking and monitoring protocol submissions since 2004. The electronic protocol submission by the research community and the IRB member’s ability to view the system are the last phases of the development effort.

What does Coeus eIRB actually do?

Coeus’ web-based researcher portal allows the researcher to prepare, submit and track the protocol in a secure environment through all review steps that are defined by Yale policy. The robust routing functionality helps to ensure institutional compliance with such required reviews and notifications. Documented collaboration between the researcher and the pre-reviewers makes sure that a sound protocol is submitted and scheduled for review by the IRB.

How does Coeus eIRB benefit Yale research teams and Yale?

Researchers save time.

  • Researchers no longer need to manually collect signatures and approvals from co-investigators, department chairs and other research oversight committees; nor must they physically visit the IRB office to deliver the protocol submission and pick up correspondence.
  • By electronically submitting an initial protocol application the researcher simultaneously sends out an email to colleagues on the research project informing them that the protocol is being submitted and reminding them of their obligations in accepting to participate in the research, specifically training requirements and disclosure of real or potential conflicts of interest.
  • When submitting to the IRB the researcher is simultaneously submitting others charged with the protection of research volunteers.
  • Yale Researchers and IRBs have an electronic record of the protocol submission, documents, IRB findings and determinations.

What University oversight committees, departments and signature authorities are using Coeus eIRB to review and approve the research?

The following committees and authorities now accept electronic submission of the protocol through Coeus eIRB. They provide comments, approvals and attestations through Coeus eIRB as well.

  • Yale School of Medicine Department Chairpersons and/or their designees
  • Pediatric Protocol Review Committee (PPRC)
  • Yale Center for Clinical Investigations and its Science and Safety Committee when necessary (YCCI and SSC)
  • Yale Cancer Center’s Protocol Review Committee (PRC)
  • Magnetic Resonance Review Committee (MRRC)
  • Yale University Radiation and Safety Committee (YURSC)
  • Yale PET Center

Do other University departments use Coeus eIRB to collect information about research?

Yes, the data collected within Coeus eIRB is shared with other Yale departments to help them with their reporting and ensure Yale and the investigator’s compliance with requisite government requirements and University policy. Departments using Coeus eIRB for informational and operational needs include:

  • Yale Medical Group (YMG)
  • Yale HIPAA Privacy
  • Yale HIPAA Security
  • Yale’s Conflict of Interest and Conflict of Commitment Committee
  • Yale New Haven Hospital
  • Connecticut Mental Health Center
  • Apt Foundation
  • Yale University Departments and Sections, e.g., Psychiatry, Child Study, Nephrology, Digestive Diseases, etc.
  • YSM Dean’s Office
  • Yale’s Deputy Provost for Biomedical & Health Affairs

What are the system and operating requirements for using Coeus eIRB?

  • Coeus eIRB has been successfully used on IBM as well as Macintosh computers.
  • Preferred browsers are Internet Explorer and Firefox.
  • Coeus eIRB can be used via a Yale Virtual Private Network (vpn) from outside of Yale permitting researchers the ability to work away from the office.

When will Coeus eIRB be available to the Yale School of Medicine research community?

January 2009.

Where can I learn more about getting registered and trained to use Coeus eIRB?

You can learn more about training opportunities on the training page.

Who can I contact if I have specific questions about submitting a protocol?

The HIC staff would be happy to answer any questions you have regarding online submissions. In addition, you'll be able to attend one of our scheduled "First Friday" sessions in January or February for additional support. You can bring a protocol with you that you need to submit. Click on the link below to see the schedule.

Outside of training, what other support tools are available to me?

A series of training tools are available to support your learning and use of the Coeus system. Click on the following link to access either our 2-page Coeus "cheat sheet" or our interactive, online training tool which walks you through the step-by-step submission process.

When will Coeus be available to non-Yale School of Medicine researchers?

Late spring, summer 2009

I'll be approving submitted protocols. Do I need to attend special training in order to do this?

No, but you should send a designee if possible and familiarize yourself with the training required of approvers. You can access training materials at www.yale.edu/coeus.

Will the deadline to submit protocols to the HIC for review remain the same -- Tuesdays by noon?

No, the new submissions deadline will be Monday at midnight for electronic submissions and Monday at 4:30 p.m. for paper submissions that are delivered to the HIC office.

How do I access the Coeus eIRB application to submit a protocol?

You can access the application from http://www.yale.edu/coeus.

Can Coeus eIRB be used at the VA?

Unless you have a connection on the Yale subnets you won't be able to access Yale University applications. Yale VPN is not enabled/functional for people using CT-VAMC network connections -- it does not meet VA.gov security specifications.

If someone @WHVA wants a connection via the Yale subnets they need to have a valid Yale NetID, a business need for the Yale connection and then they have to contact Fred Wright (fred.wright@va.gov) to get permission. They would also need separate hardware (another Yale owned computer).

When will paper submissions no longer be accepted?

Currently it’s voluntary for investigators to electronically submit protocols. Paper submissions will no longer be accepted after July 2010. However, the Yale Cancer Center’s Protocol Review Committee (PRC) will only be accepting electronic submissions as of June 1, 2009.

Can I send in an amendment or renewal on a protocol that was originally submitted in paper?

Yes, you can send in an amendment or renewal to a protocol that was submitted on paper provided that the protocol is still active. Simply upload the current consent documents with your request for an Amendment and/or Renewal if the study is still open to enrollment.

How do you create an amendment?

Creating an amendment is a simple process. You can get step by step directions by viewing the Coeus Amendments quick guide. In addition, you can view the online training module about submitting an amendment.

I usually have to upload a marked up copy and a clean copy of the consent documents and protocol. Will I need to do that for amendments?

You will need to send in the marked up copy of any document that you are modifying via the amendment.

Regarding attachments and versions, how does the system know which version of a protocol or consent form is the most recent one?

In “View History” the most recent version will be displayed on the top line. You’ll be able to view older versions within the system, but they’ll be marked as Expired or Not approved.

How do I get a primary reviewer to sign my protocol?

Effective February 1st, Primary pre-Review and signature of a protocol prior to it being submitted to the IRB for formal review is no longer required. A Primary Reviewer may be made available to the Investigator upon request as an investigator is writing a protocol. Otherwise, the Primary Reviewer will be assigned to take a careful review of the protocol just prior to the actual meeting of the convened IRB.

Last update: May 29, 2009 (vm)