Employee Training Programs as a Quality Improvement Tool for Clinical Trials

April 16, 2021

Companies operating in regulated environments deliver a multitude of tasks while complying with regulatory mandates.

It is essential that employees working in good practice (GxP) regulated environments understand these operational challenges and are well-trained to perform their jobs effectively. Adequate scientific knowledge, practical skills, and the right attitude are essential to maintain task efficiency and deliver projects successfully.

Training employees is a key focus area for clinical trial management. With robust training plans, companies ensure that all their employees conduct their task efficiently and reliably.

The importance of employee training and development in clinical research

As per the GxP regulations, training is fundamental to achieve quality. GxP regulations require all employees to be trained according to their function so that each individual is competent in performing their assigned tasks.\(^{1,2}\)

Adopting and implementing a quality culture ensures that the employees are well trained and understand their role well before initiating their tasks.  

Regular and timely training programs allow employees to understand the industry regulations and interdependencies better. It also enhances their critical thinking abilities and analytical skills, which ultimately ensures data quality and integrity.      

Investing in employee training can lead to significant returns that go far beyond task-oriented accomplishments. Training professionals in quality improvement can positively impact their attitudes and behaviors and can be acknowledged as the best way to enhance skill acquisition.\(^4\)

Training objectives – How training programs can promote organizational excellence

Organizational excellence depends on the strength of its employees—their skills, education, and competencies play a key role in improving the quality management system and shaping the organizational culture. Improving training methods should be a priority in quality management - this ensures that each task and every process is conducted the right way, every time.

Training should be driven by organizational needs and regulations. Meticulously planned onboarding and sustainable training help achieve a culture of quality throughout the establishment; whereas, inadequate training can lead to process variation, hampering performance and increasing cost.\(^5\)

Investing in employee training programs and development is essential for operational excellence and continual business growth. Conducting regular training programs on the following topics can help employees acquire the knowledge and skills to perform their roles effectively: 

  • Regulatory and local legislation knowledge
  • Clinical/scientific knowledge
  • Indication / therapeutic area proficiency
  • Knowledge of the investigational plan
  • Knowledge of the device/ Investigational Medicinal Product being studied
  • Knowledge of sponsor procedures
  • Skills to implement new digital technologies
  • Analytic skills – ability to collect information, analyze it, and make decisions
  • Effective communication skills

With proper training and mentorship, employees can effectively meet the industry demands, such as key internal and external changes and major developments.

By systematically combining quality management with training and implementing innovative learning strategies, companies can develop a compelling training program with measurable outcomes.

Methods for effective training and development

Risk-based approach

Quality improvement mandates a path different from conventional fact-based learning. From the traditional approach to the latest risk-based approach, there are several methods to impart training. Following the risk-based approach allows companies to successfully address the training needs for projects of different type and sizes.\(^{2,6}\)  

Adaptable and sustainable

An efficient training program must be adaptable and sustainable. The program should include relevant policies for framework, guidance, and infrastructure to enable proper development and implementation.\(^7\)

Training formats

There are several formats of imparting training. On-the-job training, workshops, online seminars/courses, ad-hoc collaborative exercise, and interactive meetings/webinars are some commonly used formats. Selecting the best training format will depend on the needs and infrastructure of the organization.\(^4\)


As compliance with regulations plays a critical role in the clinical research industry, including assessments with continual training is important. The effectiveness of the training should be measured objectively to ensure that the training successfully delivered the desired outcome. Mentorship, supervision, and feedback loops should be included as part of the training program.\(^4\)

Active learning strategies

Another aspect is the inclusion of active learning strategies. Active learning engages participants to execute the learning and adapt problem-solving skills. Training should ideally be planned proximate to when the guidance/knowledge is required so that learnings can be implemented with ease.\(^5\)  

Dokumeds – Committed to leveraging high-quality training

Dokumeds believes in leveraging high-quality training to improve operational efficiency and support growth. Dokumeds follows the latest industrial trends, especially considering the current pandemic situation and ever-changing environment. Dokumeds' work is adept with the current digital transformation and new approaches for monitoring and data analytics.

Dokumeds management believes that a generalized approach to learning cannot yield successful results. At Dokumeds, each training program is tailored as per the purpose, application, and specific needs of distinct roles.  Training sessions are organized to implement the new strategies on risk assessment, risk-based monitoring, safety reporting, changes in the informed consent process, and distribution of the investigational medicinal product.  Dokumeds learns from the results and consistently integrates the learning to improve operations and outputs. 


  1. Rönninger S, Schmitt S, Rangavajhula V, Hough E, Lyda J. Considerations on Auditing and GxP Requirements along the Product Lifecycle. PDA J Pharm Sci Technol. 2012;66(5):396-402.
  2. ICH Expert Working Integrated addendum to ICH E6 (R1): guideline for good clinical practice E6 (R2) 2015. Jun 11, [2019-04-01]. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf. Accessed: 28 March 2021.
  3. Daudelin DH, Selker HP, Leslie LK. Applying Process Improvement Methods to Clinical and Translational Research: Conceptual Framework and Case Examples. Clin Transl Sci. 2015;8(6):779-786. 
  4. Quality improvement training for healthcare professionals. The Health Foundation. Available at:  https://www.health.org.uk/sites/default/files/QualityImprovementTrainingForHealthcareProfessionals.pdf. Accessed: 28 March 2021.
  5. Kleppinger CF, Ball LK. Building quality in clinical trials with use of a quality systems approach. Clin Infect Dis. 2010;51 Suppl 1:S111-S116.
  6. What is the Purpose of GCP Training? SOCRA. A Quality Management Perspective. Available at: https://www.socra.org/blog/what-is-the-purpose-of-gcp-training-a-quality-management-perspective/. Accessed: 28 March 2021.
  7. Wiltsey Stirman S, Kimberly J, Cook N, Calloway A, Castro F, Charns M. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012;7:17.
  8. McDermott MM, Newman AB. Preserving Clinical Trial Integrity During the Coronavirus Pandemic. JAMA. 2020;323(21):2135-2136. 

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