Kuali Protocols

Kuali Protocols is Indiana University’s web-based IRB submission system required for all human subjects research. The submission must be initiated by the investigator or his/her study staff. The IU IRBs are the IRB of record for all IU campuses as well as our medical center affiliates, including IU Health, Eskenazi, and Roudebush VA Hospitals. Additionally, IU allows the use of external IRBs, including independent IRBs and other academic medical center IRBs, under certain circumstances.

Permission to use an external IRB must be requested via Reliance Request in Kuali Protocols. Please contact the Human Subjects Office for additional information.

Kuali Protocols is protected by CAS authentication and can be accessed only by those with an IU computing account (username and passphrase). If you need an IU computing account for the purpose of accessing Kuali Protocols, complete the IU Affiliated Account survey to request an account.

Kuali Protocols and OnCore are partially integrated, which means that information regarding initial IRB Approvals, Amendments, Renewals, Reportable Events, and Closeouts will all flow seamlessly and securely one way from Kuali Protocols into OnCore in real time.

 

The Office of Clinicaonjunction with the Office of Research Compliance (ORC), is implementing a partial integration between O KC IRB, which involves IRB review data only.

Steps for Entry of IRB Review into OnCore

Step 1

Submit your protocol, consents, etc. to the IU IRB.

Step 2

Go to OnCore and enter the IU IRB number.

Step 3

The IU IRB approves your protocol, consents, etc.

Step 4

The protocol’s review data flow from Kuali Protocols to OnCore.

Step 5

You add consent information to the review record in OnCore.

Steps for Entry of Reliance Review on an External IRB

Step 1

Submit your request for reliance on an external IRB to the IU IRB.

Step 2

Go to OnCore and enter the IU IRB number.

Step 3

The IU IRB approves your reliance request. The review data flows from Kuali Protocols to OnCore creating a Reliance Review record. (Add consent information for the IU HIPAA to the reliance request review record.)

Step 4

Create an initial IRB Review record using external IRB information.

Step 5

Add treatment consent information to the Initial Review record in OnCore.

OnCore/Kuali Protocols Integration FAQs

Any of the following reasons below may result in your IRB review not displaying in OnCore:

    • Your review was approved by an external IRB and not by the Indiana University IRB using the Kuali Protocols system.
    • Your review was approved prior to 02/27/2020.
    • Your review was approved prior to the IRB number being entered into OnCore.
    • The IRB number entered in OnCore is incorrect.
    • The IRB review has not received a final action in Kuali Protocols (i.e. the review is only provisionally approved).

Duplicate reviews are typically the result of someone manually entering the review information prior to approval by the IU IRB.

The integration includes Initial Approvals, Reliance Requests, Amendments, Renewals/Continuing Reviews, Reportable Events and Closeouts.

No, we were unable to map documents in this version of the integration.

Currently, there is no standard naming convention for consents in Kuali Protocols that can be mapped directly to OnCore. There are also fields required in OnCore, such as version date, that aren’t available for mapping directly from Kuali Protocols.

Data is available in OnCore once a final action is taken on a review in Kuali Protocols. This occurs in real-time. 

Yes, this number is reviewed and updated in OnCore each time a final action is taken on a review in Kuali Protocols. 

For reviews that do not expire, a default date of 01/01/2500 displays in OnCore. 

No, only reviews with a final action taken on or after 02/27/2020 will display in OnCore. 

Yes, reviews that do not meet the criteria to display in OnCore may be entered manually. If the review should be displaying and is not, contact OCR Research Systems Support for assistance. 

You can contact OCR Research Systems Support by e-mail or phone: 

Email: oncore@iu.edu

Phone: 317.278.2600

Any of the following reasons below may result in your IRB review not displaying in OnCore:

    • Your review was approved by an external IRB and not by the Indiana University IRB using the Kuali Protocols system.
    • Your review was approved prior to 02/27/2020.
    • Your review was approved prior to the IRB number being entered into OnCore.
    • The IRB number entered in OnCore is incorrect.
    • The IRB review has not received a final action in Kuali Protocols (i.e. the review is only provisionally approved).

Duplicate reviews are typically the result of someone manually entering the review information prior to approval by the IU IRB.

The integration includes Initial Approvals, Reliance Requests, Amendments, Renewals/Continuing Reviews, Reportable Events and Closeouts.

No, we were unable to map documents in this version of the integration.

Currently, there is no standard naming convention for consents in Kuali Protocols that can be mapped directly to OnCore. There are also fields required in OnCore, such as version date, that aren’t available for mapping directly from Kuali Protocols.

Data is available in OnCore once a final action is taken on a review in Kuali Protocols. This occurs in real-time. 

Yes, this number is reviewed and updated in OnCore each time a final action is taken on a review in Kuali Protocols. 

For reviews that do not expire, a default date of 01/01/2500 displays in OnCore. 

No, only reviews with a final action taken on or after 02/27/2020 will display in OnCore. 

Yes, reviews that do not meet the criteria to display in OnCore may be entered manually. If the review should be displaying and is not, contact OCR Research Systems Support for assistance. 

You can contact OCR Research Systems Support by e-mail or phone: 

Email: oncore@iu.edu

Phone: 317.278.2600 

Additional Support