Contact Us

Procedure

How to Complete

Agreements for specimen and/or data sharing (DUA,  DTA, MDTA, etc.)

Send agreement via email to CHR_ComplianceApprovals@kpchr.org for review and processing. You can find agreement templates here: KFRI Contract Templates

CITI Account Questions and Training Status

Contact the IRB Coordinator, Andrea.Volz@kpchr.org.

Data Transfer Request (DTR)

Use the simplified form in Compliance Manager to explain how the data will be transferred.  Contact CHR_ComplianceApprovals@kpchr.org if you need access to a study in Compliance Manager.

De-Identified Data and Aggregate Data disclosure approvals

Submit completed De-Identified or Aggregate Data form to CHR_ComplianceApprovals@kpchr.org.  (Note that an Aggregate Data form is only required in certain circumstances – see the Aggregate Data Flowchart.)

eIRB Questions

Email eIRB@kpchr.org.

General compliance questions

Email CHR_Compliance@kpchr.org.

HIPAA Research Training for New Hires

Hiring manager provides new hire with a training PowerPoint and an attestation that the supervisor will have the employee complete.  The PowerPoint is in the new hire packet.

IRB Education and Training

Contact the IRB Manager, Kaija.H.Maggard@kpchr.org .

IRB Review Status and Questions

Contact the assigned IRB Coordinator listed at the top of the page in eIRB. You may also contact the RSPO team at CHR_ResCompTeam.kpchr.org.

Quality Improvement Monitoring Program

Contact the Quality Improvement Compliance Coordinator, Melinda.J.Allie@kpchr.org.

Preparing and Creating an IRB Submission

For help with completing IRB protocols and thinking through study material design, contact an IRB Coordinator, Andrea.Volz@kpchr.org.

Potential HIPAA violations

Email CHR_Compliance@kpchr.org immediately (same day the issue is discovered).

Preparatory to Research (PTR) Request

Submit a completed PTR form to the Manager for Research Analytics, Michael.J.Allison@kpchr.org.

RAMP reviews

Review the options in the IRQ and the Risk Assessment Tool, if applicable.  Contact the Research Compliance Manager, Andrea.M.Seykora@kpchr.org, early in the preparation of your IRB submission with any questions.

Reliance Agreements:

For general help with reliance (or ceding) agreements contact an IRB Coordinator, Andrea.Volz@kpchr.org.

For help with the NIH sIRB mandate, contact the IRB Manager, Kaija.H.Maggard@kpchr.org or IRB Coordinator, Andrea.Volz@kpchr.org.

For help with SMART IRB, contact the IRB Manager, Kaija.H.Maggard@kpchr.org or IRB Coordinator Andrea.Volz@kpchr.org.

Reports of noncompliance or suspected noncompliance

Email CHR_Compliance@kpchr.org.

Reportable New Information (RNI) Questions or Assistance

For help with reporting timelines and what needs to be reported, call or email IRB Manager, Kaija.H.Mggard@kpchr.org.