The Trainer’s Toolkit: How to Design Successful Blended Learning

artistic representation of blended learning

Anatoly Gorkun MD, PhD, Chartered MCIPD
Senior Manager, MedImmune

Abstract: Blended learning is a training program in which the audience learns the content through a combination of different learning methods with some element of self-control over time, place, and pace. This article provides an overview of audience learning preferences and styles, blended learning, and how to choose the most appropriate learning methods for a specific training program. Examples of and tools for learning methods are provided.

Introduction

Blended learning fits all types of learners and people of all ages. It can be used in clinical trial training.

Learning Preferences

The first step in developing a training program is to understand the audience. Some people prefer to learn by listening (auditory learning), while others prefer to learn by observing or watching (visual learning), or by doing what they are learning (kinesthetic). Other learning preferences are learning individually in quiet or as part of a group. Learners are diverse and have different learning preferences. Training must address those preferences as well as learning needs.

Learning Styles

Development of a training program requires knowledge of learning styles and methods. In 2004, Coffield analyzed 13 learning styles. These 13 learning styles consist of 3 elements:

  1. Information processing
  2. Instructional preferences
  3. Learning strategies.

People can process information verbally or visually. Sensory modalities are auditory, visual, and kinesthetic. Instructional preferences can be collaborative or independent, and some people prefer to learn at a particular time of day, such as morning or afternoon.

Learning strategies are adaptive responses to learning a specific type of subject matter. Task-based strategies for learning include:

  • Using the imagination to create images to understand the content
  • Role-playing
  • Using organizational skills to summarize and create visual representations such as charts, graphs, and timelines.

Other learning strategies involve focusing on what the person knows and using resources such as the Internet and dictionaries.

A learning method is any intervention that is deliberately undertaken to assist the process of learning by individuals or teams, or learning at the organizational level. Different combinations of learning methods can be used in a blended learning program. Examples of learning methods include:

  • Classroom training
  • eLearning (computer-based modules)
  • Podcasts and vodcasts
  • Self-learning (reading)
  • Learning from others
  • Team meetings and briefings
  • Virtual classroom
  • Use of Internet resources
  • Social networks
  • Gamification.

Classroom training is quite popular, however, much of this is being replaced by eLearning (computer-based modules). Self-learning (reading) is a preferred method of learning. Team meetings and briefings can be used at the end of the project to share and learn from mistakes. Gamification is learning by playing games.

Blended Learning

Blended learning is a training program in which people can learn the content through a combination of different learning methods with some element of self-control over time, place, and pace. There are many benefits of blended learning (Table 1). People have different learning styles, and blended learning addresses more audience preferences. Learners are more engaged when a training program offers a variety of types of content.

Some training related to clinical research can be complex and may involve the development of practical skills; however, other training can be as simple as an instruction. Different learning methods are used depending on the complexity of the training. Blended learning also makes training more efficient and more fun.

Sometimes trainers assume what the learners know, and need to know, and how they want to learn. Learners, however, have their own learning needs and preferences. So, it is always a good idea to check the gap between the trainer’s assumptions and the learners’ expectations.

Selecting Learning Methods

There are many considerations in choosing the learning methods for a training program, starting with the nature of the learning needs (Table 2). This also includes the complexity of the topic and whether the training needs to help learners develop practical skills or not. Learners’ background and experience plays a role in choosing the learning methods. For example, a Good Clinical Practice (GCP) training program will be different if it is for learners with no previous GCP experience than if it is an annual refresher training for experienced company staff.

The number of learners to be trained and the organizational culture are among considerations in choosing the learning methods for a training program. The learning methods differ if there are dozens of learners versus hundreds or even thousands of them. Organizational culture refers to the preferences of senior management. Feedback from previous training should also be considered.

Other considerations in choosing learning methods include costs and budgets, time and resources, learner preferences, and locations (whether the training will be delivered at one or multiple locations or even in different countries). Some training may require immediate implementation, for example, to address corrective and preventive actions or to ensure that staff learn and understand new regulations.

Each learning method has pros and cons. Pros of classroom training include having an instructor who provides leadership, flexibility, insight, and the opportunity to practice skills in a risk-free environment. Classroom training combines input from the trainer and the learners, and thus, an opportunity for learners to share ideas and experiences. The trainer provides immediate feedback to learners. Classroom training helps learners to develop knowledge and skills, and it enables them to ask questions and get answers.

The cons of classroom training include its expense and the need to deliver it in person. Classroom training is time-consuming and takes people away from the workplace. Logistics of classroom training (room, equipment, and food) can be complicated, and appropriately qualified instructors are necessary to deliver the training.

Pros of eLearning include that each learner can complete the training at a time that is convenient for him/her, and many different scenarios can be used, which is visually engaging. Once developed, eLearning can be reused many times, and it can be relatively inexpensive. There is no need for learners to leave the workplace for eLearning. Cons of eLearning include that the learners cannot ask questions and there is no control over learning and whether the learners understand the subject. It is also difficult to motivate the learner to complete the eLearning, and learners cannot learn from others or experiment the same way as in a classroom.

Self-learning (reading) is simple and inexpensive. It is easy for learners to access. However, self-learning has the same downsides as eLearning.

Learning from others has many benefits. Learners can develop practical skills by practicing the skills under supervision, while using tools and equipment in the real-world environment. The learning can be tailored to specific needs and integrated easily and quickly. Learners can get immediate feedback. Cons of learning from others include the cost, especially if traveling is involved. The trainer must be carefully selected to prevent the transfer of bad habits and sub-standard training. Learning from others can be ineffective if it is rushed or poorly planned.

Examples of Learning Methods

Classroom training can include a mix of different activities. The training session plan for a training program on asthma that the author developed with subject matter experts included:

  • Pre-training assessment activity
  • Introduction
  • Presentation
  • Video
  • Discussion
  • Presentation
  • Individual assessment activity
  • Discussion
  • Small group assessment activity
  • Discussion.

eLearning can be fun. For example, informed consent training e-modules by MedImmune/AZ included a virtual environment where learners could “walk” through a number of hospital offices with different real case scenarios involving consent and re-consent of subjects.

Self-learning is usually used for learning policies, instructions, guidelines, and SOPs; however, it is difficult to motivate people to complete the training on time. To ensure that learners understand SOPs, managers should discuss the SOPs with their direct reports.

Video can be an effective and useful learning method. The author managed a training project producing a video series on oncology drug development covering the stages from target identification through the product license application. The series had over 20 videos of 20 to 40 minutes each and was available on the company intranet. These videos were filmed by a professional operator; however, it is possible to create simple videos by filming a presenter with a simple camera or a mobile phone.

The Internet has many resources for learning, including information from regulatory authorities, such as the Medicines & Healthcare Products Regulatory Authority in the United Kingdom and the U.S. Food and Drug Administration in the United States. LinkedIn groups provide useful resources for training, too.

Useful Learning Tools

Table 3 highlights a few useful tools in developing training programs, including video-creating software such as Camtasia, CamStudio, PicPick, and some others. They are used to record video on a computer and can capture what is on the computer screen. These tools are good for developing electronic training on systems. One possible use is to develop training programs on electronic case report forms.

Articulate is a simple tool for building e-learning modules in PowerPoint. Once installed, Articulate is integrated into PowerPoint. Voiceover can be added to slides. The PowerPoint presentation can be easily transformed into computer-based training modules by clicking a button in Articulate. The computer-based training can easily be shared with investigators, clinical research sites, and others.

Conclusions

Learners have different learning styles and preferences. A blended learning package can include different learning methods, such as:

  • Self-learning
  • eLearning
  • Videos
  • Classroom (instructor) training
  • Learning from others.

Selection of learning methods is based on many factors, including:

  • The nature of the learning needs
  • Learners’ knowledge
  • Complexity of the training
  • Budget
  • Location(s)
  • Number of learners to be trained.

Blended learning fits different learning styles and makes training more efficient.

Virtual Project Management

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP
Senior Director, Project
Covance, Inc.

Abstract: Clinical research project management is increasingly conducted globally across multiple time zones and cultures. In order to be successful, certain adaptations must be made to routine practices. This article describes key terms and basic concepts of virtual project management, considerations for effective communication and collaboration tools, and ways in which the Project Management Institute knowledge areas can be applied to a virtual framework. Situational examples are provided. While this has been written in the context of clinical trials performed by a biotech or pharmaceutical sponsor engaging a CRO, the same concepts could easily be extended to any geographically dispersed project team.

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Influencing Without Authority

Barbara van der Schalie, MS
Learning and Professional Development Manager
Clinical Research Directorate, Clinical Monitoring Research Program
Leidos Biomedical Research

Abstract: Effectively exercising influence, even when one may not have the formal authority to mandate action, is a challenge many clinical research professionals face in their daily work. This article describes the interpersonal and leadership skills necessary to ensure that one’s agenda is not only considered but actively requested, and how successful professionals build networks of relationships with stakeholders and influencers. This article explains the difference between influence and authority, identifies different sources of influence, and describes different influencing styles.

Disclaimers:

  • This project has been funded in whole or in part with federal funds from the National Institutes of Health’s National Cancer Institute, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercials products, or organizations imply endorsement by the United States government.

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A Modern CRA Perspective on the Use of Technology in Clinical Trials

By Takoda Roland, CCRA, CCRP

Founder of Philadelphia Pharmaceutical Research

Disclaimer: The examples noted in the following are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted below is an aggregate of many sites and studies and is not necessarily an exact representation. The original version was written entirely on a smartphone while flying from Philadelphia to Puerto Rico.

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Resolving and Preventing Repetitive Problems in Clinical Trials

April Bishay, BA, MBA
Senior Manager, Clinical Compliance, MedImmune

Anatoly Gorkun, MD, PhD
Chartered MCIPD, Senior Manager, Scientific & Compliance Training, MedImmune

Abstract: Clinical trial findings from audits reveal the same type of problems year after year despite the implementation of quality systems, compliance training, and corrective and preventive action plans. This article provides an overview of the root cause of these problems and how to ensure that corrective and preventive actions are addressing the actual problem rather than its symptoms. Actual case study illustrates some of the common problems in clinical trials.

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Evaluating the Protocol: Can the Clinical Research Site Really Do this Study?

Monika Gaa, MBA, CCRP
Senior Feasibility Coordinator, Nationwide Children’s Hospital

Christine Baker, BA, CCRP
Senior Regulatory Coordinator, Nationwide Children’s Hospital

Abstract: Protocol evaluation is critical to determining the feasibility of a study. This article describes the key elements for evaluating protocols for financial feasibility, recruitment, and practical application. Strategies that have worked well at Nationwide Children’s Hospital are highlighted.

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Similarities and Differences Between Good Laboratory Practice and Good Clinical Practice

 

Milton V. Marshall, PhD, DABT, CCRP, President, Marshall & Associates

Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them.  Many similarities exist between the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and the Good Clinical Practice (GCP) Guidelines (International Conference on Harmonisation E6 Good Clinical Practices), such as the requirement for a protocol, training documentation, and data retention. Differences also exist, such as the level of detail written in the requirements or whether adherence is mandatory. This article compares GLP regulations and GCP guidance, which have similar objectives: to determine the safety and efficacy of the product and document the study results for subsequent study reconstruction.

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Successful Collaboration Between the Clinical Research Site and the Monitor

Sharon Appelman-Eszczuk, BScN, RN, CCRP
Faculty of Medicine and Dentistry
University of Alberta  

Cathy Laferriere, BSc
Senior CRA
Quintiles Canada

Abstract: Good communication is the key to successful collaboration between clinical research site staff and the monitor, facilitating recruitment and ensuring compliance with Health Canada regulations. This article provides an overview of the monitor’s expectations of the site staff and the site staff’s expectations of the monitor. Tools to aid the site staff and the monitor in working together are provided. Scenarios describe possible issues that arise in monitor-site staff relationships and illustrate ways to resolve situations where the site staff and the monitor do not see eye to eye.

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Consent Forms in Context: How Long is Long?

Mark Hochhauser, Ph.D., Readability Consultant/IRB Member, Golden Valley, MN

Abstract: As the science and regulatory requirements behind clinical trials have evolved over the past few decades, consent forms have become very long. This article compares the word count of some oncology consent forms with other documents, and shows that those consent forms are longer than ethical guidelines and federal regulatory documents. Because too many consent comprehension tests and health literacy measures are not psychometrically sound (and of limited value), efforts to improve comprehension and health literacy continue to be serious problems now and in the future.

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What is the Purpose of GCP Training? A Quality Management Perspective

Graeme Downes, Senior Director, Clinical and PV QA, AstraZeneca

Anatoly Gorkun, Senior Manager, Scientific and Compliance Training, MedImmune

Abstract: The Good Clinical Practice (GCP) regulations require that each individual involved in conducting a clinical trial be qualified by education, training, and experience to perform the respective tasks. This article provides an overview of the purpose of GCP training, ways of delivering GCP training, and components of the GCP training package. An effective way to build a risk-based GCP training program is described.

Disclaimer: The views and opinions presented here are those of the authors and not of MedImmune or AstraZeneca.

Introduction

GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global. For example, in the United Kingdom, regulation 28 of the UK SI 2004/1031 states that, “no person shall conduct a clinical trial… otherwise than in accordance with the conditions and principles of GCP.” From a global perspective, the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice §2.8. states: “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” This means that each individual involved in conducting a clinical trial must receive training in GCP.

Even though legislative requirements have been in effect for several years and most if not all companies claim to have GCP training programs in place, non-compliance with GCP is frequently identified, as evidenced through monitoring, audit, and inspection findings.

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