Author: SOCRA

Catching up with 2023 SOCRA President’s Award Winner Tammy Neseth, MA, CCRP, CIP

Tammy Neseth, MA, CCRP, CIP

The global clinical research community will converge live and in-person from September 29 – October 1 at SOCRA’s 2023 Annual Conference in Montreal, QC, Canada. During the event, we will present the President’s Award to Tammy Neseth, MA, CCRP, CIP, in recognition of her exceptional service and commitment to SOCRA’s mission.  

With a foundational career at the Mayo Clinic focusing on colorectal cancer screening, Tammy has worked extensively in the clinical research regulatory and compliance sectors. Her journey includes pivotal roles, most notably as the Director of Operations for the Mayo Clinic Institutional Review Board.  A Saint Mary’s University of Minnesota graduate, Tammy has been a dedicated member of SOCRA since 2003, undertaking leadership positions including (but not limited to) co-chairing the SOCRA Oncology Conference and the SOCRA Site Coordinator / Manager Workshop, leading the SOCRA Southeast Minnesota Chapter, and serving on the SOCRA Certification Committee and Board of Directors. 

Join us as we delve into a candid conversation with Tammy about her career journey, her take on clinical research, her experience with SOCRA, and a wealth of insights and inspiration. 

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Using Evidence-Informed Practices to Improve eConsent

Authors: Annie B. Friedrich, PhD, Erin D. Solomon, PhD, Jessica Mozersky, PhD, & James M. DuBois, DSc, PhD

Author affiliation (all authors): Bioethics Research Center, Washington University School of Medicine, St. Louis, MO, USA

With funding from the National Institutes of Health, our team at Washington University School of Medicine developed an online toolkit, ConsentTools.org, to make consent processes in clinical trials more effective and efficient. It shares information, resources, brief videos, and tools to help clinical research professionals implement several evidence-informed consent practices. These include:

  • Using plain language
  • Using appropriate formatting
  • Assessing for understanding

Randomized controlled trials demonstrated that using these practices can increase participants’ understanding and appreciation of consent information.[1, 2] In this blog post, we explore how to adapt these practices when using eConsent in clinical trials.

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Back Together: 11 Irresistible Reasons to Attend the *Live and In-Person* SOCRA 2023 Annual Conference

Jennifer Li, BSc, CCRP, SOCRA Board President
Quality Manager, Cancer Clinical Research Unit
Princess Margaret Cancer Centre / University Health Network
Toronto, Ontario, Canada

SOCRA’s Annual Conference has been successfully carried out virtually for the past three years. Each event was carefully curated to deliver personal experiences through interactive sessions and virtual meeting spaces for attendees to connect. Despite our best efforts, physical gatherings have a unique energy that virtual platforms can only partially capture. “There’s a powerful dynamic in face-to-face interactions,” said SOCRA Board President, Jenn Li. “It’s in the spontaneous, organic exchanges in hallways and during coffee breaks where some of the most inspiring ideas are born.” And with this in mind, we are delighted that the SOCRA 32nd Annual Conference will be in person this year! 

As we prepare to convene in Montreal, QC, Canada, from September 29 to October 1, 2023, we caught up with Jenn to uncover some of the compelling reasons that make this year’s event a must-go for clinical research professionals. Join us as we delve into the top eleven reasons to attend – and stick around for Jenn’s favorite tips for optimizing your conference experience.  

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Celebrating Clinical Trials Day 2023: Let’s Raise Awareness & Honor Research Professionals

May 20th marks Clinical Trials Day (CTD), an annual day of celebration and reflection for the clinical research community. This date commemorates the day in 1747 when James Lind launched the first-ever clinical trial, laying the foundation for modern clinical research. Since 2005, CTD has been celebrated internationally to raise awareness about the importance of clinical trials and honor clinical research professionals’ contributions.  

In this article, we’ll explore why it’s important to raise awareness about clinical trials and how we can honor the invaluable work of research professionals on this special day. In addition, we’ll explain why supporting and celebrating the people who dedicate their lives to improving public health through clinical research is more important than ever. So, let’s kick off the celebration of Clinical Trials Day 2023 together! 

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My Seat at the (Institutional Review Board) Table

Lauren Surden, MSW, CIP 

Sterling IRB 

I often get asked about the education and experience needed to be selected to serve on an Institutional Review Board (IRB).  The fallback response is that I hold a Master’s degree in Social Work (MSW), however, my education and work experience is only part of what I bring to my seat at the IRB table.  Understanding who makes up an IRB is important in understanding the ethical review process for clinical research. 

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Developing a Test Taking Plan when Pursuing Professional Certifications

Laura R. Holtz

MS, PMP, CCRP

Jessica Rowe

MA, MS, CCRP, CIP

People pursue certifications for various reasons. Some pursue certification for professional credibility or recognition, while others aim to meet position requirements for job opportunities. “Certification demonstrates your commitment to superior professionalism, to upholding industry standards, and for continued learning (www.mbopartners.com).” Regardless of the motivation, all test takers want to be successful. In our respective roles, we are often approached by research professionals with questions about certification and about taking a certification exam. We rely on our backgrounds to construct a reply. Laura Holtz has a background as a teacher and as a project manager. She relies on her experience in those roles to provide guidance regarding certification. Jessica Rowe has a background in academia and in instructing adult students enrolled in graduate courses. She calls upon that experience to provide tips and tools for successfully pursuing professional certification. Of course, both authors rely on their own experiences pursuing their certifications when answering related questions.

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A “WIN” for FDA’s ORA Women Investigators

In Interview with

Andrace De Yampert, MS

This Women’s History Month, we’d like to express our gratitude to those in the clinical research community who dedicate their careers to advancing inclusivity and equality in our field. Whether through small acts of empowerment or sweeping organizational changes, every effort helps pave the way for a brighter future for all.  

In the spirit of empowering women in clinical research, this post will introduce you to the Women’s Investigator Network (WIN) and the women behind it. This distinctive program at the Food & Drug Administration (FDA) Office of Regulatory Affairs (ORA) supports women serving as ORA investigators by providing opportunities for professional development, leadership training, and personal empowerment. With more than 300 members and growing, WIN is a shining example of how organizations can foster a culture of inclusivity and diversity within the clinical research community. 

In honor of WIN’s second anniversary, we caught up with Andrace De Yampert, FDA ORA Office of Bioresearch Monitoring Operations (OBIMO) Program Expert and WIN Vice Chair, to learn more about her, the network, and its impact on women investigators at the FDA.  

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10 Reasons to Attend the 16th Annual Device Research & Regulatory Conference

Angie Rock

MBA, CCRP

Kathi Durdon

MA, CCRP

Early in her medical device research career, Kathi Durdon, MA, CCRP, discovered a gaping hole in the professional conference offerings: most were geared toward pharmaceuticals, not devices – so she created one.

“My initial incentive for starting an annual device conference was because I needed help. I wanted to connect with subject matter experts, get new updates, and share resources. I knew it would be helpful for others, too,” said Kathi. As a member-driven organization, SOCRA enthusiastically supported Kathi’s vision, and the Annual Device Research & Regulatory Conference was born.

“Thanks to SOCRA’s support, I could create a different kind of conference – one where attendees would come every year to discuss and learn about an evolving array of topics. I also wanted a full complement of speakers who are experts in different areas – not just one or two areas,” Kathi recalled.

With Kathi at the helm, the first Device Research & Regulatory Conference was held in 2007, and sixteen years later, it’s still the medical device research “go to” conference. The conference started as a two-day program and then the faculty added a half-day Device Basics workshop thanks to past co-chair, Donna Headlee, RN, BSN, CCRP, who developed and still presents at the program today.

As we gear up for the 16th year, the Device Research & Regulatory Conference is still going strong. And as Kathi prepares to turn over the reins to Angie Rock, MBA, CCRP in 2024, the two gathered to commemorate Kathi’s tenure, to discuss the importance of the program, and to discuss future plans for the conference.

“This conference is Kathi’s brainchild. I’m honored to be a part of this phenomenal program – it is the premier conference for medical device professionals and one of the first that is entirely clinically oriented,” said Angie.

In this post, we’ll outline Kathi and Angie’s top ten reasons to attend this annual conference and why it’s important for device newbies and experts alike.

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Medicare Coverage Analysis – A Billing Compliance Perspectives

Sachit Verma, MD, MBA, FAPCR

Medicare Coverage Analysis (MCA) is a uniform methodology of analyzing the items and services provided in a clinical research study, i.e., a comprehensive review of protocol documents that helps identify the appropriate payor (sponsor or third-party) for each study service, assessment of the protocol driven items and procedures that can be billed to either insurance, as routine cost, or as costs billable to the study sponsors.

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Leveraging eSource as a Study Manager for Remote Monitoring 

By:  Takoda Roland, CTM, CCRA, Associate Director of Clinical Operations, Sitero

 

I have long been a proponent of the potential of eSource and its advantages in clinical trials.  From my experience as a CRA (Clinical Research Associate) I first wrote about eSource in Nov 2018 SOCRA and Jan 2019 ACRP which enabled me to see that clinical research was only just scratching the surface on leveraging eSource to fundamentally change the way we are monitoring clinical trials.  At the time I did not expect to be find myself in a position to make a meaningful shift towards remote monitoring.  Several years later while working as a CTM (Clinical Team Manager) COVID forced CROs (Contract Research Organizations) to rethink their monitoring paradigm.  Drawing from both my own and my team’s experience with eSource, our study was able to successfully implement a remote monitoring process to mitigate the issues of running a clinical trial during a pandemic.  Even as someone who had long advocated for remote monitoring using eSource, I found myself astounded at the success our team achieved.   

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