Clinical Research Training on the Web

The demand in clinical research for additional training and education continues to grow at an exponential rate. With the emergence of knowledge-based culture in the industry comes the challenge of continuing to develop qualified teams of research experts on a global scale. The importance of training has emerged as a dominant theme in auditing for research excellence in the industry.

The acceptance and implementation of the International Conference on Harmonisation (ICH) guidelines and the current trends in Food and Drug Administration (FDA) regulations have emphasized the requirement for qualified and well-trained clinical research personnel. FDA and the Office for Human Research Protections (OHRP) in the United States, and the ICH guidelines, identify training as a key component of the regulatory audit checklist.¹ Good clinical practice (GCP) training followed by certification may become a requirement as a symbol of research excellence.

Many of us have experienced the burden of initiating a clinical research study only to discover the lack of expertise of the research teamoften when it is too late. Poorly trained or untrained clinical research personnel create a huge burden on the industry in time, safety, and expenditures. When sites are terminated, the effects are costly to all parties involvednot only financially but also ethically. At a research site, the training and experience of the research team are indicators of quality in performance.

The challenge of educating researchers on a global scale contributes to a need for up-to-date information delivery. Innovative educational programs initiated in combination with technological advances are beginning to meet this need.

The Internet is a vehicle to deliver information in an environment that enhances virtual place and virtual time learning. It allows training of larger groups of research teams and presents endless opportunities. It offers an avenue for continued education and a venue for providing educational credits. Accreditation and validation of information retention can be done via the Internet through examinations or shorter tests/quizzes online.

Certificates can then be delivered over the Internet and printed as documentation to verify learning. Technology offers updated information delivered routinely by e-mail or online newsletters. Internet knowledge-sharing and networking can take place online to encourage international peer learning.

The implementation of an online learning program involves both financial expense and time. What are the steps that you should take to develop an online training environment?

The e-learning process. Complete an online education feasibility assessment at your company or clinical research site. If your company staff or research team members have a desire to learn but a lack of time or other obstacles to learning, you might find an online training program useful. Convenience for learners and cost effectiveness are the primary advantages of online technology training (see box).

Ask your management or training team, Will an online learning program assist our staff? Will our employees benefit from an online training program?

The actual construction of an online program involves many steps. The traditional live course should be assessed for the appropriate transfer of content onto the Internet. Then decide the delivery method of that content by evaluating your companys or sites online infrastructure.

In designing the program, you need to decide what features are important to include in the online course. People usually want a program that is both convenient for learners and intellectually stimulating. The learners should have a rigorous learning experience and feel as if they have had a good workout of the mind.

The online atmosphere should encourage attendees to create individual learning plans and should enhance online interaction. Capturing the live classroom interaction is a challenge in online education.

Adult learners strive as researchers do to be self-directed, analytical, and hypothetical. The online environment should reflect these theories about adult learning as well as encourage interaction.

Interactive learning can be achieved by setting up a knowledge-sharing environment in which learners share information or analyze situations online through the use of chat rooms, bulletin boards, and e-mail. In this way, Web-based peer learning can enhance problem-solving skills. Learners can be encouraged to discuss group issues and to develop strategies to implement new learning in real research practice.

The program must also meet your organizations learning objectives and goals. You must determine your companys or sites educational philosophy and ask, Will this online program achieve our educational mission? If your company pedagogy involves the interactive transfer of information, then your program should allow your learners to network online.

Clinical research learning is a high order of learning, which includes analysis, synthesis, and evaluation in contrast to the more rigid didactic method of learning. Two types of learner or attendee interaction should be considered for adult learnersinformation interaction and interpersonal interaction. Both can involve two online techniques:

• Trainer-to-student interaction
• Student-to-student interaction.

These forms of positive engagement can be achieved through a combination of advanced technology and media such as teleconferencing or video stream over the Internet. Solutions to e-learning can be expensive. So be cautious! Quotes for e-learning solutions will range tremendously. Consider possible costs and technology tips in setting up a virtual classroom:

• Hire a good HTML coder for your company.
• Work with a technology consulting group.
• Interview several companies.
• Obtain several quotes breaking down all details of services provided.
• Develop your own budget with items.
• Outline which features you want to implement.
• Learn technology lingoHTML coding, Java Scripts, Cold Fusion, Flash.

Be aware that prices for e-learning solutions will vary depending on use of time, phases of development, and the level of experience of the coders and designers. And before investing in expensive technology,

• develop your goals and timelines for the online project.
• get deadlines and commitments in writing.
• find out what costs will accrue for changes made throughout the running of the program.
• ask if these changes can be made in-house by your staff.

By 2002, there will be 40 million users on the World Wide Web, and online learning is predicted to become the largest sector in information technology transfer. Welcome to the new knowledge-based society!

References
1. David LePay, Director, Office for Human Research Trials (OHRT), Keynote Address, Association of Clinical Research Professionals (ACRP) Annual Meeting, San Francisco, CA, 30 April 2001.

SIDEBAR: Advantages of Technology Training

1. Learners choose the course time schedule
2. Learners decide the course location
3. Learning networksgroup learning forumscan be developed online
4. Study opportunities 24 hours a day, 7 days a week
5. No travel to attend courses, or travel costs
6. Less time lost at work
7. Self-paced learning
8. Individual learning plans
9. Cost effectiveness
10. Reduced overhead costs
11. Up-to-date and ongoing information through membership fees.

Paula Jones-Wright,BScN, RN, MEd, CCRC, CCRA, is president of CreateNet, Inc., 1484 Carlton St., Halifax, NS B3H 3B7, Canada, (902) 425-3038, fax (902) 425-6879, pjwright@createnetinc.com.