Addressing Compliance Gaps with Focused Training Programs

Naila Ganatra

Naila Ganatra, MEd, General Manager, Barnett International

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Rather consistently over the years, several general areas have comprised the most usual areas of clinical investigator noncompliance, although there are emerging signs that CDER is finding more cases of significant noncompliance today.[1] Overall, the following five areas represented the most frequent citations in CDER-issued Form 483-Domestic Inspectional Observations in FY2017:

  • Failure to follow investigational plan/protocol (26% of sites cited);
  • Inadequate/inaccurate records (14% of sites cited);
  • Inadequate drug accountability (3% of sites cited);
  • IRB communication (2% of sites cited); and
  • Failure to obtain and/or appropriately document subject consent (2% of sites cited).

For trials conducted outside the U.S., the list of most frequent citations is similar, and given year-over-year trends, it is likely that many of the above deficiencies will remain on the top 5 lists in 2018. Why is it that we as an industry cannot meaningfully impact these statistics?

It can be argued that all of the above areas of noncompliance can be easily addressed with focused training programs. When the root cause of the learning need is clearly identified, a well-designed training solution with relevant case scenarios, practice in building new skills, and measurement of learning outcomes can be quite powerful. Training, thoughtfully designed and done well, can present a prime opportunity to address knowledge gaps, and ultimately, circumvent the types of issues that are seen over and over again in common inspection findings.

Despite numerous ROI-focused studies that demonstrate the positive outcomes on well-designed training initiatives on overall job performance, employee engagement and retention, and ultimately costs, all too often we hear that training budgets are minimal (or non-existent), and employers commonly delay training due to their employees’ inability to take time away from critical work tasks. However, it is important to remember that the key benefits of well-planned training initiatives include:

  • Improved overall employee performance
  • Improved job satisfaction and morale
  • Increased adherence to quality standards and role requirements
  • The opportunity to identify and address knowledge gaps and weaknesses
  • Reduced employee turnover and an enhanced company image

Given technology advances in training, many training platforms are available to meet the demands of busy professionals, providing flexibility in costs and time away from daily job responsibilities. Successful implementation of competency-based training programs includes the design and delivery of training using an appropriate platform that supports employee engagement and optimal performance. Some options include:

Virtual Classrooms: Interactive online learning environments such as virtual classrooms (i.e. Blackboard, Saba, and others) include many of the same attributes as instructor-led classes. Live engagement between the trainer and learners (presentations, information sharing [whiteboard], discussion and Q&A, access to learning resources, and group collaboration) promotes learner collaboration on course activities in groups via a designated online “room.” This approach also allows the trainer to work with each group in their “room” to answer questions and to support and facilitate learning. In a virtual classroom environment, assessment mechanisms can include knowledge checks, case study reviews, and more robust exams. Virtual classrooms provide the platform for the trainer and globally located participants to collaborate and interact just as they would in an instructor-led class, or at their own pace.

Live Classrooms: The value of face-to-face training cannot be understated, and live, instructor-led classroom training brings the trainer and learners into the same room, in the same location, allowing for active, intimate engagement and interaction between the trainer and learners. In addition to course delivery, facilitated discussion and Q&A time helps learners to internalize training and often, team collaboration is greatly enhanced through group work. Assessments can be delivered in a variety of ways, including knowledge checks, robust exams, and/or demonstration of learning through interactive exercises.

Web Seminars: Web seminars are interactive, live training presentations in which the trainer and learner connect via platforms such as WebEx, Adobe Connect, and others. Webinars include: live training presentations, discussion and Q&A with the trainer and learners, knowledge checks, as well as communication features via the “chat” tool and breakout groups.

Self-Paced eLearning: eLearning is a self-paced, online learning activity that delivers training to the learner, but does not include live trainer interaction (discussion, Q&A, etc.). eLearning content and technology use varies, particularly as it relates to interactivity with the learner. For example, slides with audio narration do not allow learner engagement with the course materials; however, the use of eLearning software engages the learner with exercises, activities, knowledge checks, and quizzes.

The value of training your teams – including new and experienced personnel – cannot be overstated, particularly in ensuring that your teams have the skills they need to operate in a GCP-compliant fashion. As an industry, it is critical that we recognize the value of employee training and development, and in particular how it raises the competencies of our shared workforce as a whole.

[1] Barnett’s Good Clinical Practice: A Question and Answer Reference Guide 2018 and (https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM438250.pdf)

About Barnett International:

Barnett International’s consulting, education and training services provide thought leadership and the expertise required to achieve your training goals while utilizing a variety of training platforms, resulting in the initial and on-going development of a competent and compliant workforce. We invite you to hear several of Barnett’s senior trainers address critical training topics at the upcoming ACRP 2019 in Nashville:

Inspection Readiness: Beginning with the End in Mind
Donna Dorozinsky, RN, MSN, CCRC, Senior Trainer, Barnett International

Workshop: Best Practices to Become a Preferred Site
Janet Holwell, CCRC, CCRA, TIACR, FACRP, Senior Trainer, Barnett International

Risk Management: The Crash Course
Susan Leister, MBA, PhD, CQA, CSSBB, Trainer, Barnett International

Unveiling the Mystery of Quality Tolerance Limits
Susan Leister, MBA, PhD, CQA, CSSBB, Trainer, Barnett International

Clinical Project Schedule Management: Successful Start-Up Planning
Marla Hoelle, CCRA, Clinical Training Manager, Barnett International