ABOUT ACUTE CARE - REGULATORY PROFESSIONALS

The Acute Care Research Regulatory Professionals (ACRRP) group is a novel collaboration of acute care research regulatory specialists representing institutions that comprise Cincinnati’s Academic Health Center (AHC). Formed as an outgrowth of the Acute Care Research Council (ACRC) in early 2016, this first-time alliance includes key regulatory professionals from fourteen acute care research units.

The mission of the ACRRP is to create a collaborative community of Acute Care Research Regulatory Professionals who support innovative and expanded acute care research by:

• Sharing educational resources/expertise and standardizing regulatory compliance best practices

• Creating timely awareness of new regulatory guidelines/policies and pursuing most-efficient implementation strategies

• Strengthening communication among regulatory stakeholders across the AHC, becoming “the place to go” for conversation/resolution of regulatory issues

Acute care research and its corresponding regulatory process are challenged by the:

1. Need to interface with patients 24/7, within minutes to hours of their illness or injury

2. Inability to schedule/recruit patients via traditional means

3. Frequent inability to direct-consent patients due to patient care and family considerations that surround a catastrophic health event

4. Movement of patients throughout the health care system (EMS, ED, Surgery, ICU).

Today, the Acute Care Research Regulatory Professionals group advocates for a common effort to overcome these challenges and others by eliminating regulatory systems’ barriers and increasing institutional cross-support. Through a commitment to process improvement, economies of scale and coordination of activities, this group has realized accomplishments that include:

• Mechanisms to identify/resolve common efficiency barriers — e.g., new CITI training administrative access saves hours/week for UC and CCHMC staff

• Facilitation of a process to standardize/share SOPs commonly used across AHC 

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REFERENCES

• Cincinnati Children’s IRB (note: only accessible from Cincinnati Children’s network)

• University of Cincinnati IRB

• UC Office of Research Events + Training

• UC Health Office of Clinical Research

• DOD Flowchart (presentation by Carolina Rodriguez) 

• CITI Program - News and updates

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CONTINUING EDUCATION RESOURCES

• CCHMC CRP Meetings: 3rd Wednesday of the month, 2pm–3pm (CEUs available); open to all CRPs

• UC Health CRP Meetings: 1st Friday of the month, 9am–10am (CEUs available); open to all CRPs

• CCTST Events Calendar (CEUs available for select events)

• Regulatory Affairs Professionals Society

• Webinars (CEUs available):

  • ADVARRA (Schulman IRB, Kinetiq, Quorum IRB)

  • WCG Webinars

  • Forte Research System

  • FDA Guidance Webinar Series and Archives

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