Digital Tools for Billing Compliance

By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC
Kelly Willenberg & Associates

Abstract: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. This article describes digital tools that clinical research professionals already have that they can use to facilitate billing compliance as well as the benefits and challenges of each tool. Clinical research professionals must determine which tools will be most effective at their site.

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Human Factors Testing and Clinical Research

Tim Reeves, CHFP
Founder and Managing Director
Human Factors MD

Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and transdermal patches. Through human factors studies, researchers evaluate how users and devices perform in low-frequency high-risk situations that may not occur in controlled clinical trials. This article provides an overview of the role of human factors testing in combination product development as well as how human factors studies complement traditional clinical trials in establishing safety and efficiency in drugs and devices.

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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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Developing Effective Study Start-up Processes

Clinical research start-up study

Jennifer Goldfarb, CCRP
Senior Director, Clinical Research Support Office
Children’s Hospital of Philadelphia            

Grace Wentzel, CCRP
Director, Clinical Research Services
The Research Institute at Nationwide Children’s Hospital

Abstract: The study start-up process sets a study up for success or failure. This article provides an overview of study start-up, the players on the study team, and the infrastructure required for successful study start-up. Tools for the study feasibility assessment for dissecting and implementing the protocol and for ensuring compliance are described. Challenges to study start-up and solutions to those challenges are provided.

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Steps to Ensure an A+ on Your IRB Audit (Part 2)

medical practitioners having a meeting in a hospital boardroom

Click here to read part 1

IRB Audits and Inspections

IRB audits can be conducted by federal agencies overseeing research such as the FDA or the Office for Human Research Protections, research bases, study sponsors, and IRBs. Pharmaceutical sponsors do routine monitoring of their studies at regular intervals. The Toledo Community Oncology Program’s research bases only audited the program every three years. This can make it difficult to know about mistakes made years earlier and to put quality assurance processes in place when needed.

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Steps to Ensure an A+ on Your IRB Audit (Part 1)

Pamela Shoup, CCRP
Past Executive Director, Toledo Community Oncology Program
Current Research Manager and IRB Coordinator for the Toledo Clinic, Inc.

Abstract: A well-organized institutional review board (IRB) ensures excellent quality assurance in the regulatory area and enables the IRB to score an A+ on regulatory inspections conducted by the U.S. Food and Drug Administration (FDA). This article describes best practices in IRB management and tools to help prepare for an FDA audit. Lessons learned from experiences at the Toledo Community Oncology Program are highlighted.

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Effective Training Delivery and Evaluation: Professional Approaches and Tools

Group of clinical research professionals

Anatoly Gorkun, MD, PhD, Assoc CIPD
Senior Manager
Scientific and Compliance Training, MedImmune

Abstract: Different professional training techniques can be used to achieve training goals. This article describes how to deliver efficient training sessions that benefit learners, evaluate training sessions, and use the evaluation results to make necessary improvements. Topics covered include learning styles, planning the training, different training styles, monitoring learning progress and adjusting the training, and bringing the training session to a close. Examples of training evaluation tools and their role in continual improvement of training for clinical research professionals are highlighted.

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An Overview of the General Data Protection Regulation (“GDPR”) for Clinical Research Organizations

James F. Bush, Esq. [1]

Abstract

In 2018, the European Union’s General Data Protection Regulation (“GDPR”) came into full force and effect. With the growth of international multi-center clinical research studies, U.S.-based research organizations and investigators will now be governed by the GDPR to the extent that they control or process Personal Data of EU citizens in the course of their research. While efforts to attain compliance with HIPAA and HITECH within the U.S. provide clinical researchers a head-start in attaining compliance with the GDPR, substantial additional efforts must be undertaken to avoid the risk of enforcement penalties for failure to meet the mandates of the GDPR in conducting clinical research. A basic understanding of the important rights granted to study subjects, the jurisdictional reach of the law, logistical and organizational considerations, and the possible risks of enforcement action is now an essential competency for those engaging in clinical research involving EU citizens. The goal of this paper is to provide a regulatory overview of the law and its effect on clinical research in order to enhance the competency of investigators, project managers, and decision-makers involved in such clinical research.

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The Value of Centralized Monitoring

group of clinical researchers

Joanne Malia
Associate Director, Clinical Documentation Management
 Regeneron Pharmaceuticals

Abstract: Regulatory agencies are advocating for sponsors to take risk-based approaches in various clinical trial-related activities, especially in the area of monitoring. Sponsors are looking at and beginning to use centralized monitoring. This article describes centralized monitoring, regulatory and industry expectations and initiatives related to centralized monitoring, the value of centralized monitoring in enhancing data quality in clinical trials, and use and documentation of centralized monitoring,

Disclaimer: The views and opinions expressed in this article are those of the author and should not be attributed to the Society of Clinical Research Associates or Regeneron Pharmaceuticals.

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The Changing Landscape of Human Subjects Research

Amy Waltz, JD, CIP
Associate Director – Regulatory Affairs, Reliance, Outreach
Indiana University

Abstract: Understanding context is key to understanding the regulations and complying with regulatory requirements. This article explores the historical context and events that shaped the current human subjects protection regulations and how changes in human subjects research and public perception have impacted the proposed revisions to the human subjects protection regulations. The 2017 revisions to the Common Rule (45CFR46) and the impact of these revisions on government funded research are also addressed.

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