Institutional Requirements Review

SCTR Communications
March 29, 2022
What's new

The Office of Clinical Research has recently expanded upon the Institutional  Requirements Review (IRR) for research. This process is conducted to verify that study documents are harmonized in a way that ensures regulatory and billing compliance prior to the study being pushed to Epic. Discrepancies found during the IRR review can result in a delay in study activation in Epic by impeding the push from SPARCRequest© to Epic.

The IRR process checks to confirm the following:

  • The IRB approved protocol is the same version reviewed by the PRA team during their initial review.

Because revisions  to the protocol could result in changes to the study billing plan, study teams are responsible for ensuring that the PRA team has reviewed the same protocol version as the IRB.             

If changes are made to the protocol after initial PRA review and before the study has been pushed to Epic (e.g. changes were made to the protocol document to address IRB comments during the IRB review process), the protocol must be submitted for another PRA review regardless of the changes.  Please submit an Additional Review Required request via SPARCRequest©.

  • Cost language included in the informed consent is consistent with language provided in PRA Summary Memo.

If asked to change the cost language in the contract or informed consent that is not in alignment with the PRA summary memo, please contact the PRA Coverage Analyst at the OCR assigned to the study.

  • Appropriate language regarding research participation being documented in the participants legal medical record is included in the informed consent

If the study is going to be in Epic, the Informed Consent needs to reflect the appropriate MUSC standard language.

  • The selections made in SPARCRequest regarding participant de-identification and inclusion of research results in MyChart align with language reflected in the IRB approved Consent.

  • PRA team has reviewed the language in the fully executed contract and budget to ensure alignment with the coverage analysis.

Please direct any questions/concerns about the IRR review to Sarah Snider

Related Link

Office of Clinical Research