Audit Monitor-RMAS Guidance

Thank you for your participation in our upcoming AAHRPP site visit scheduled for Monday, September 28th and Tuesday, September 29th.

This Institution’s Human Research Protection Program (HRPP) is a comprehensive system to ensure the protection of the rights and welfare of subjects in Human Research. The Human Research Protection Program is based on all individuals in this Institution along with key individuals and committees fulfilling their roles and responsibilities. Your role in our Human Research Protection Program is essential to the successful functioning of our HRPP.

In preparation for the AAHRPP Site Visit, we have extracted key components of our HRPP that are most applicable to your role. Here is what we are asking you to do:

first

Review the PowerPoint presentation that has been created for your role. In this presentation, there will be various documents that are part of our HRPP “Toolkit” that are most applicable to your role.

Audit Monitor-RMAS PowerPoint Presentation

 

second Review the documents that have been highlighted for your role. These documents are available for you below. Start with HRP-101: Human Research Protection Program Plan as this is the document that sums up how our HRPP works. Then move on to the other documents. Should you have questions when going through these documents, don’t forget to write them down. We will be going through these documents (and any questions) at our upcoming training check-in (see #4). 

Audit Monitor-RMAS Guidance Documents

HRP-101 HUA Human Research Protection Program Plan

HRP-060 SOP: Annual HRPP Evaluations

HRP-061 SOP HUA Monthly Evaluations of the HRPP

HRP-070 SOP HUA IRB Records

HRP-071 SOP Standard Operating Procedures

HRP-072 SOP HUA IRB Records Retention

HRP-430 CHECKLIST HUA Investigator Quality Improvement Assessment