Better Medicine Faster" for Patients
Release Date :
Employee training
Release Date :
Ms. Katsuie Shiraki
- In addition to in-house training and union training, there were requests for training for CRCs (Clinical Research Coordinators) belonging to union member companies that could be easily implemented in their spare time.
- They wanted a system that was both cost-effective and easy to use.
- In addition to training conducted in person, e-learning training can now be implemented by introducing the learningBOX. Tests, etc. are conducted to consolidate and confirm knowledge.
- Low cost, easy to use, and satisfied with support.
The Cooperative Society for Clinical Development Support Network (SMONA*1) (read: SMONA) is the only cooperative in this industry in Japan, authorized by the Kanto Shinetsu Bureau of Health and Welfare of the Ministry of Health, Labour and Welfare in May 2001 based on the Small and Medium Enterprise Cooperative Law. Clinical trial support providers work daily to improve the accuracy and speed of clinical trials. In order to cope with the new era in a severe economic environment, clinical trial support providers, mainly SMOs and CROs (*2), cooperate with each other to overcome the limitations of small and medium-sized companies and the challenges they face on their own, and contribute to society for patients waiting for new drugs. He talked about the deciding factors for introducing the system and how it is being utilized.
1 SMONA is an acronym for Strategic Management and Operation Network Association for Clinical Study.
2 SMO is an organization in which CRC (Clinical Research Coordinator) coordinates various operations to ensure smooth progress of clinical trials, and CRO is an organization in which CRA (Clinical Development Monitor) audits whether clinical trials are progressing as planned.
learningBOX is a system that is both "cost-effective" and "easy to use
Why did you decide to implement learningBOX?
SMONA is a cooperative of companies that support clinical trials, and its strength is that member companies can work together to address issues. The cooperative was started with the conviction that there is much that can be achieved if small and medium-sized companies work together in the spirit of mutual support.
Clinical trials are conducted by clinical research coordinators (CRCs) under the direction of the investigators at the medical institutions where the trials are conducted. For this reason, CRC training at member companies is important, and in addition to in-house and union training, there was a desire to use e-learning to provide efficient training. This led us to consider introducing the system.
What were the deciding factors for the introduction of learningBOX?
We did a lot of research in introducing this system. Of course, budgets are limited and cost is very important. Also important was the ease of use: the e-learner should be able to learn and acquire knowledge easily, and the administrator should be able to use the system easily.
I myself am in charge of operation and management, but I am a very analog person, so when the idea of introducing the system came up, I thought it would be impossible for me to manage it. However, since it was a request from a member company, I was thinking about which of the many systems out there would be easy to use, and that is when I came across learningBOX. learningBOX was the one system that cleared the two requirements of "cost" and "ease of use" in an outstanding manner.
What exactly do you learn in a situation where a variety of companies participate in the cooperative and highly specialized content is required?
The main learners of the learningBOX system are CRCs from union member companies. The union has created a program called "Practical GCP Training" (hereinafter referred to as "GCP Training") and uses the learningBOX system for the purpose of consolidating knowledge and deepening understanding of GCP. GCP is a law in clinical trials.
The rules are established to protect the human rights and safety of participants in clinical trials to the greatest extent possible, and to accurately examine efficacy and side effects in a scientific manner in clinical trials. In order to be a CRC trusted by patients, medical institutions, and sponsors, you are required to have a proper understanding of GCP.
Repeating the process until you get 100 points is the best way to consolidate knowledge.
What role does the learningBOX play in GCP training?
The purpose of this GCP training is to confirm that each member company has a solid understanding of GCP, and to conduct tests, etc., in the learningBOX.
So, as a union, you use e-learning to conduct tests and other activities to establish standards to achieve this level of performance?
Yes, we are working on it. Our goal is for everyone to score 100 points in the GCP training first, because GCP is subject to legal revisions, and what was previously OK may now be against the rules due to the revisions. In this sense, it is an advantage to be able to continuously update new knowledge regardless of your career.
SMONA also conducts the "CRC Certification Examination" once a year. Those who pass the exam can obtain SMONA certification. The "CRC Certification Examination" is a written test, and this year will be the 18th time it has been administered. learningBOX has since been introduced, and is also used for testing to support the continued certification of certified personnel.
How is the actual content created? Please tell us about your operational methods.
Since the content is highly specialized, the questions are prepared mainly by educators from member companies, who participate as SMONA Education and Training Committee members. The answers to the GCP training questions are provided byTrue/false（We emphasize not only the questions (0x00 questions), but also the explanations, so that the students can read the explanations after answering the questions and be convinced that this is important.
We ask CRC staff to "repeat the process until you get 100 points" within a month, and repeating the process helps to solidify knowledge. This will help to solidify the knowledge.
After each GCP training session,Gradesfunction to check the results.Usersby company in Group registrationI also appreciate the fact that I can do it.
Looking into video distribution for local member companies in the future
Are there any other e-learning systems other than learningBOX that you considered?
Of the three companies we finally narrowed down to, learningBOX seemed to be the easiest to use. It also met our requirements in terms of cost. In the end, I visited your company and met with your staff, and I felt that I was in good hands. I was very anxious about the work of registering problems in the system and the management aspect, but you kindly explained everything in an easy-to-understand manner, and I was able to gain peace of mind from learningBOX's support system.
CRC is important to have a trusting relationship with patients and other people involved in clinical trials, so the union provides a lot of group training on communication, which is a matter we place a great deal of emphasis on. I was very impressed with the communication skills of the staff at your company.
Thank you! So the final decision was "people"?
I believe that "people" are what counts, and although it is e-learning, it is "people" that I turn to when I have a problem. The peace of mind of being able to ask for help and get the right advice is very important to me.
How easy is the learningBOX to use?
The very best part is that it is sensible to use. I find it easy to register and operate problems. I would highly recommend this system to anyone who is actually thinking about implementing it, regardless of the size of their company, because it is so sensible and easy to use; it makes you think that even if you don't have an IT person, you can use this system.
How did learningBOX's prices compare to other companies?
It was so cheap that there is no comparison anymore. At the time of installation, everyone was concerned, "Are you sure it's that cheap?" When we introduced the system, everyone was concerned about whether it would be safe at such a low price. That is why we visited the head office in Tatsuno City, Hyogo Prefecture, from Tokyo, to see if we could trust the company, including this aspect. I think we were able to implement the system because of LearningBOX in terms of price, ease of use, support, and so on.
What are your future plans for using e-learning?
We hope that GCP training will help CRC's to be confident in their work in support of clinical trials. This will also lead to the safety and security of patients (subjects). In addition to knowledge of GCP and ALCOA (*3), CRCs are also required to be in direct contact with patients in the medical field, explaining clinical trials as well as providing support for their emotional burden.
We hope to utilize the functions of the learningBOX to create e-learning content related to communication and other human resource development in the future. In the future, we would like to make it possible to distribute video of group training sessions for our member companies in rural areas.
3 ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, the following five basic elements required of records (source documents) necessary to reproduce and evaluate the factual course of a clinical trial. Originality" and "Accurate.
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