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Indiana University
Office of Research Compliance Newsletter 7th Edition
October 14, 2013
Kuali Coeus IRB
In this issue:
 
 
KC IRB Phase II – Is Coming November 11, 2013

What will KC IRB Phase II mean for you?

No more email submissions – the KC IRB system will be used for all submissions

All new protocol submissions, and any changes to existing protocols will be submitted for IRB review via the KC system, including renewals, amendments, non-key personnel updates, and FYIs (prompt reports and noncompliance). KC IRB will not be utilized to notify the IRB of study closure. Study closures should still be submitted via email to irb@iu.edu.

Additional IRB forms eliminated

This phase will bring the removal of four more IRB forms: all three Continuing Review forms as well as the Amendment form.

Streamlined continuing review process

Researchers will answer an online questionnaire to report annual progress, then perform a review of the study status and documents in KC IRB, confirm they are current, and submit. No need to upload all current study documents with renewals!

Researchers will also be able to amend study documents at the time of renewal with a single submission – a Renewal with Amendment.

Non-key investigator updates via KC IRB

Changes to affiliated study personnel who are listed as either Non-Key – Interacting, or Non-Key – Not Interacting, will occur via the KC IRB system. Simply create an Amendment in KC IRB and submit with the protocol type of ‘IRB Review Not Required.’ Look for the corresponding new Training Guide for additional details.

Enhanced access to protocol documents

All active studies have now been updated to include all current study documentation, so researchers and their designees will enjoy access to study documentation 24/7/365.

HSO Website will continue to be the source for required forms

Researchers should continue to first visit the HSO website to obtain the required forms for IRB submissions. These forms will then be uploaded to the KC IRB system.

 
 
KC IRB Reminders, Issues and Fixes
  1. Notifications from KC IRB: Investigators receive notifications when the following actions occur in KC IRB:
    1. An item is submitted for review: any time either a study team member or an HSO staff member clicks the ‘submit’ button to forward a study submission for IRB review, a notification is generated. Keep in mind that in the course of a review, there may be several ‘submit’ notifications generated, since this action occurs both at the initial submission of the item as well as following any pre-review processing.
    2. An item is approved: once the ‘approve’ action is taken in KC IRB, appropriate study team members will receive a notification. Following this notification, investigators may retrieve approved study documents within the KC IRB protocol document.
    3. A study is due for renewal: renewal notifications begin 60 days in advance of expiration and will result in a total of three notifications if a renewal is not submitted.
    4. A study has expired: an expiration notice is sent on the day of study expiration. Please note that the study expires at midnight, so research may continue on the day of expiration. The study is considered expired, and thus study activity must cease, the day following the expiration date.
  2. KC IRB search functionality: Investigators and study personnel reported difficulties utilizing the ‘All My Protocols’ search on the OneStart portal into KC IRB. This search is currently disabled until the functionality has been corrected. In the meantime, investigators may access protocols via the main “Search” also on the OneStart portal.
  3. Renewal reminders: A handful of studies did not receive renewal reminders despite impending expiration dates. The root cause was discovered and a fix has been applied to preclude recurrence.
 
 
IRB Protocol Conversion

Your studies, including submission history and current study documents, are now fully available in KC IRB. During the months of August and September, the HSO oversaw the process of moving all study information and documents into KC IRB from multiple sources. Documents for every active study were converted into KC IRB during this effort totaling approximately 53,000 documents.

 
 
KC IRB Training will continue in October and November

There are a number of ways you can take advantage of KC IRB Training opportunities:

  • Face-to-face Training Sessions: Phase II sessions will feature a presentation from an experienced HSO staff member and trainer. Following the presentation, you will have the opportunity to remain at the computer lab and gain assistance from a staff member while you prepare your KC IRB submission. Bring any relevant study materials on a flash drive and sit with a staff member to submit your study!

    You can register for KC IRB training sessions at the KC IRB Training Sessions page. For Phase II training, be sure to choose a session entitled, ‘KC IRB – Post-Approval Actions.’

  • Open Labs: Already attended a face-to-face session? Ready to submit your new study or post-approval item using KC IRB? Bring your study information and questions and sit down with an experienced HSO staff member in an open lab setting.

    Prior registration is appreciated; choose the sessions entitled ‘KC IRB Training – Help Session and Q&A’ at the KC IRB Training Sessions page.

  • eLearning Videos and Training Guides: In addition to live training sessions, a series of eLearning Videos and Training Guides are available on our website for you to review at the eLearning Videos and Training Guides page.

    Coming soon! New Training Guides:

    • Notifications and Action Lists – Understanding and Managing
    • Post-Approval Submissions – Amendments
    • Post-Approval Submissions – Renewals
    • Post-Approval Submissions – Renewals with Amendments
    • Post-Approval Submissions – Non-Key Personnel Updates

If you have any questions or need assistance registering for KC Training, contact us at kcirb@iu.edu.

 
 
KC IRB Tips

Friendly reminder!

Ensure your CITI education and Conflict of Interest (COI) disclosures are up to date. This information is viewable in KC IRB for IU personnel – simply visit the ‘Personnel’ tab, and click ‘show’ on the ‘Person Details.’ CITI and COI information are listed under the line item of ‘Trained’ and will display ‘Yes’ if both are current.

Organizational Correspondents: Are you a Department or Division which is structured such that a core team of individuals requires access to all Departmental protocols? Contact the HSO to gain automated access for these individuals: email kcirb@iu.edu

Notifications: multiple Kuali systems utilize Action List notifications and thus it can be difficult at times to identify a KC IRB notification. As such, we offer these tips:

  • Ensure your Action List is configured to send an email. Please visit the Human Subjects KC IRB Implementation page for instructions.
  • Emails regarding notifications are sent only to IU email accounts. If you do not regularly utilize your IU email account, please have it forwarded to an email account you monitor frequently.
  • It’s easy to tell to what submission the notification pertains by the study number in the ‘Title’ of the notification:
    • A 10-digit study number alone represents a new study – typically referred to as the ‘parent’ protocol
    • A 10-digit study number with a 4-character suffix represents a ‘post-approval’ submission - either a renewal, amendment, or general information (FYI) item as follows:
      • E.g., XXXXXXXXXXRXXX = Renewal or renewal with amendment
      • E.g., XXXXXXXXXXAXXX = Amendment
      • E.g., XXXXXXXXXXFXXX = FYI
Help is just a phone call or e-mail away!

TIP Please be sure to look at the KC Support and Help information found on the ORA Website under Systems Toolbox: KC IRB.

 
 
Stay tuned. More to come in future KC IRB Newsletters!
 
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