Full AAHRPP Accreditation June 15, 2007, Re-Accreditation June 15, 2010
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Five Important Reminders to PIs and Study Staff:
1.) Consent Forms must be executed properly and subjects must be consented on the currently approved consent forms
2.) Consent notes must be enter into the in EMR (see IRB Approval Letter to find out if applicable to your study)
3.) Consents must be scanned into On base
4.) Becoming A Research Volunteer brochure must be given to all subjects at the time of consent
5.) Coordinators and PIs must submit all Monitoring reports (i.e. from CRO) using the reportable events submission forms
The Centers for Medicare and Medicaid Services (CMS) recently announced that effective January 1, 2014, reporting the 8-digit clinical trial number on claims for services provided in clinical trials will become mandatory. The clinical trial number, which has been voluntarily reported since January 18, 2008, will be a requirement for the payment of claims that include items and services provided in clinical trials that qualify for Medicare coverage.
In order to meet this reporting requirement, diagnosis code V70.7/ICD-10 diagnosis code Z00.6; Examination of participant in a clinical trial must be assigned at clinical trial visits. Reporting V70.7 not only will ensure an accurate and complete medical record, it will also be the trigger to the billing staff to assign the clinical trial number to the claim.
The link to the Medicare Bulletin has been attached for review: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8401.pdf
Call or email Tricia Radatz at ext. 84968 or firstname.lastname@example.org for any questions.
The IRB staff would like you to welcome Rachel Phetteplace who has joined the staff as the Human Subjects Protection Manager. Many of you may recognize Rachel as she worked in the Bioethics Department at MetroHealth from 2009-2012. Rachel has a MA is Bioethics and an MSSA in Social work from Case Western Reserve. She has also an IRB member. We are very pleased that Rachel has joined our staff and I hope you will take the time to stop by and meet her and wish her well in her new position.
The term Human Subjects Protection Program (HRPP) refers to all the intregrated activities and departments at MetroHealth that contribute to advancing the protection of subjects in research. The IRB is just one aspect of the MetroHealth Human Subjects Protection Program. As we prepare for our 2015 AAHRPP re-accreditation we are going to be using the term to describe our program because an HRPP is more than just an IRB.