Clinical Trial Education System
"CTES"
Training programs condensing practical know-how
EP-Link provides medical institutions and sponsors with a variety of knowledge necessary for the implementation of clinical trials, which we have cultivated over many years.
Training Programs for Medical Institutions
E-learning and web-based training to learn the basics of clinical trials
P-Link’s e-learning (on demand) allows you to take courses at the trainee's own pace on GCP and other related regulations, as well as knowledge related to clinical trial administration and CRC work. EP-Link’s web-based training (live streaming) allows trainees to learn the basics of CRC work in a hands-on format. The course of study can be selected to suit each trainee.
*Web training is participation in the introductory training that our mid-career employees take.
Course of Study
B: e-learning only Course
C: web training only
Target Trainees
Basic Program
| No. | Title | Time required |
|---|---|---|
| 1 | Clinical Studies and Treatments | 1:30 |
| 2 | GCP and the Pharmaceuticals and Medical Devices Act | 1:00 |
| 3 | What is GCP 1 - Composition, Definition, and Sponsor | 2:00 |
| What is GCP 2 - Medical institution (and head of medical institution) and investigator | 1:35 | |
| What is GCP 3 - Institutional Review Board- Summary | 0:45 | |
| 4 | Clinical Trials and Ethics | 0:30 |
| 5 | Clinical Trial Protocols | 0:50 |
| 6 | Investigator’s Brochure | 1:00 |
| 7 | Institutional Review Board and Clinical Trial Office | 1:10 |
| 8 | Special or specified medical care coverage and patient reimbursement | 1:10 |
| 9 | Compensation and indemnification | 0:30 |
| 10 | Introduction to Monitoring Operations | 1:10 |
| 11 | Introduction to CRC’s Tasks | 0:30 |
| 12 | CRC’s Task (IC) | 0:50 |
| 13 | CRC’s Task (AE/SAE) | 0:40 |
| 14 | CRC’s Task (ALCOA_CRF_MedDRA) | 1:00 |
| 15 | CRC’s Task (SDV) | 0:30 |
| 16:40 | ||
| Day of the Week | Mode | Title | Time schedule | |
|---|---|---|---|---|
| TUE | Hands-on | Practical training on how to read protocols | 2:00 | 9:00〜11:00 |
| Lecture | How to read medical records | 0:50 | 11:10〜12:00 | |
| Hands-on | Practical training on medical record screening | 1:30 | 13:00〜14:30 | |
| Hands-on | Worksheet creation | 1:40 | 14:40〜16:20 | |
| WED | Hands-on | Precautions for investigational drug management | 2:00 | 9:00〜11:00 |
| Hands-on | Informed consent practice (morning session) | 0:50 | 11:10〜12:00 | |
| Hands-on | Informed consent practice (afternoon session) | 4:00 | 13:00〜17:00 | |
| 12:50 | ||||
Comments from Trainees
-
I feel that I was able to learn a lot of things from the basics to a wide range of things with the program content that deepens my understanding step by step.
It was all very useful for my own CRC and management work in the future. -
I learned a lot from the training because I learned content directly related to practical work and had the opportunity to exchange opinions with other trainees.
Thank you very much for allowing us to spend a meaningful time. -
The training was very easy to understand and gave me a deeper understanding of the business. I am very happy to have received practical training before entering the actual field.
I will make use of the experience of this training in my work and devote myself to contributing to society as soon as possible.
Training Programs for Clinical Trial Sponsors
It is important to have a deep knowledge of medical institutions where clinical trials are being conducted in order to ensure that the trial proceeds smoothly. Therefore, we provide clinical development staff and CRAs with the "reality" of clinical trials at medical institutions in a variety of formats, such as classroom training and opinion-exchange meetings. For newcomers, we mainly provide classroom training to introduce the flow of conducting clinical trials at medical institutions and the activities of CRCs in interacting with subjects. For mid-career and experienced trainees, we provide opportunities to deepen their understanding of medical institutions through meetings to exchange opinions with CRCs on themes that match their years of experience.
Example of training for newcomers
- What clinical development professionals need to know about clinical trials at medical institutions
- Deepen understanding of the status of clinical trials at medical institutions —learn about patients' thoughts on clinical trials.
- Flow of clinical trial implementation at a site
Examples of Opinion Exchange Meeting Themes
- Preparation of informed consent document
- Management of standard forms
- Data quality
- Accelerating enrollment
Participants' voices - Training for newcomers
-
In conducting clinical trials, I felt that it is important to know not only the perspective of the company, but also the perspective of medical institutions.
I would like to apply what I learned from this training to my future work. -
As medical institutions and sponsors are in different positions, there may be times when there are conflicts, but in such situations, I would like to take time to reflect on my actions from the standpoint of medical institutions based on what I learned in this training course.
-
I usually don't have the opportunity to learn about the work of CRCs, so this training gave me a good understanding of how they work throughout the day.
I was also reminded of the importance of patient centricity when we watched a video simulating dialogues with patients.
Participant's Voice - Exchange of Opinions
-
It was an opportunity to learn about the other side's (monitor's/CRC's) perspective and process.
-
I realized that there were many wasteful things, such as duplication of work, not sharing information because of hesitation, and being too considerate.
It is important to cooperate with each other to promote the clinical trial. -
I realized that a frank and free dialogue between the sponsor and the SMO provides a great opportunity to learn about the reality of the current clinical trial environment and to unravel each other's challenges and needs.
