Savini Consulting: QA/QI Automation for Post Approval Monitoring (A-PRAISE)

Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, Legal Experts, and Investigators!

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It’s amazing where life can take you.

  • First, I’m writing about helpful career hacks and insights.
  • Next, I’m providing regulatory news and sharing recent developments within the research administration and compliance fields.
  • From solo posts to featuring subscribers skilled in their craft.
  • As well as leading voices that cultivate research integrity.

Which leads me to my next point…

I had the pleasure of speaking to Cheryl Savini, President and Founder of Savini Consulting, LLC.

During our session, I had a demo of her team’s powerful (and impressive) tool, A-PRAISE.

For today’s post, I will be sharing why A-PRAISE will boost your HRRP/IRB administrative processes.

Think of A-PRAISE as your secret weapon in automating the post approval monitoring process.

As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution or organization.

Let’s learn A-PRAISE:


What is A-PRAISE?

A-PRAISE stands for “Automated Program for Research Administration, Integrity, Stewardship, and Education”.

This multi-purpose tool aids, optimizes, and simplifies for research portfolio management and quality assurance processes.

  • Have you ever wondered how many NIH grants are in your current portfolio?
  • How about the nature of your IRB studies (e.g., the number of studies that are exempt or include special populations)?
  • How about which IRB studies to review for audit?

If you’re unable to answer these questions via your current systems or procedures, you can count on A-PRAISE. This tool is the solution you never knew you needed. A-PRAISE can enhance quality improvement initiatives within your HRPP/IRB programs.

Why do I love A-PRAISE?

Allow me to share my top five reasons why I am a HUGE FAN of this product!

  • A-PRAISE is smart.
    • A-PRAISE only requires source data to work its magic. You don’t have to worry about multiple spreadsheets or manual data entry.
  • A-PRAISE is not only a tool, but a teacher.
    • Remember when I asked earlier how you would conduct an audit of your IRB studies? Maybe this is your first time performing post approval monitoring and you have no clue where to begin. A-PRAISE provides actionable step-by-step processes on how to conduct various audits. Not only are steps provided, but a schedule of when these steps should be completed.
  • A-PRAISE is holistic.
    • A-PRAISE touches all steps within the post approval monitoring process without the need for additional staff. If you’re a “one-man show”, your worries are over. From push button reports to email generation, A-PRAISE automates tedious workflows. With A-PRAISE, you are in control of your time.
  • A-PRAISE provides actionable recommendations.
    • A-PRAISE conducts a gap analysis your HRPP/IRB program should address to enhance quality. Quality improvement activities could be the creation of training documents or revamping PI forms.
  • A-PRAISE is completely customizable.
    • From dashboards to reports to metrics, A-PRAISE can be tailored to the needs of your program. Needs are variable and change over time. A-PRAISE is proactive and can keep up with changes based on what your program wants to see.

Who can benefit from A-PRAISE?

Though many folks can benefit from A-PRAISE, I immediately thought of two particular groups.

My first thought was for small HRPP/IRB offices or those programs that are currently experiencing staff shortages.

  • Another thought I had were programs who haven’t performed post approval monitoring.

Again, A-PRAISE can teach you about auditing and provide recommendations to further enhance the quality of your daily operations.

Why do we need A-PRAISE?

In an influential LinkedIn post by former OHRP Director, Dr. Molly Klote, we were reminded of the importance of proactive post-approval monitoring. You can review the full letter, but I’d like to highlight a critical aspect directly quoted from the letter:

  • “Initial IRB review and continuing review are crucial gatekeepers, but the true test of our commitment to human subjects lies in our ongoing oversight of research as it is conducted. We must move beyond a reactive stance and only investigator reporting and embrace a culture of continuous monitoring to ensure that approved protocols are executed ethically and in accordance with the approved protocol and regulatory standards. Post approval compliance monitoring should not be used to punish but to educate. We must invest in ongoing education.”

As someone who believes in promoting education and trust within the research and compliance community, this resonated with me. In these times, it’s essential to work smarter not harder. Professionals in this realm must be able to adapt quickly to overcome adversity.

A-PRAISE can be your program’s saving grace.


I hope this post gave you something to think about for your HRPP/IRB operations! There will not be a poll for this post, but readers are strongly encouraged to leave comments. I’d love to know what you think about this product and how your program can benefit.

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