E-Learning for Practitioners at Medical Institutions Participating in the iCROWN Repository
All practitioners at medical institutions participating in the iCROWN repository are required to take the e-learning courses shown below. For details, please log in to the Repository Portal and go to Related Documents > ‘Operations Manual (2.5.1 Eligibility of User Registration for the Repository Portal) found within Instructions and Manuals.
| Type | Course Name | Remarks | |
| (A) Research Ethics Course It is necessary to have completed one of the courses 1) through 3) on the right within the previous five years. Taking 1) is recommended for first-time participants. | 1) Japan Society for the Promotion of Science e-Learning Course on Research Ethics <Recommended> https://elcore.jsps.go.jp/top.aspx | The following courses meet the requirements. [For researchers] Research Ethics: Learning/Thinking through Case Studies - Principles of Integrity for Scientists - Research Ethics: Learning/Thinking through Case Studies - Principles of Integrity for Scientists- | |
| 2) APRIN E-learning Program (eAPRIN) https://edu.aprin.or.jp/ | The following courses meet the requirements. Please make an inquiry regarding other courses. Medical Researcher Standard Course Medical Researcher Recommended Course Life and Medical Sciences Course | ||
| 3) Introduction to ICR Clinical Research (ICR-web) https://www.icrweb.jp/ | “Basic Knowledge of Clinical Research (Formerly the Beginner Edition of the Introduction to Clinical Research)” Course | ||
| (B) Pathogen Course | Course for those handling pathogens, etc. | For details, please log in to the Repository Portal and view the materials from Application Information > E-Learning Enrollment/Confirmation screen. | |
| (C) Ethics Guideline Course | Course on ethics guidelines | ||
External Resources That are Beneficial for Clinical Research
The following is a partial list of courses available on the e-learning site “ICR Clinical Research Introduction ICRweb (https://www.icrweb.jp/)” operated by the National Cancer Center Japan.
| Type | Course Name | Contents/URL | |
| Basic Knowledge of Clinical Research | Basic Knowledge of Clinical Research Course | Fundamental knowledge required to carry out clinical research (including research for medical care development, epidemiological research to explore causes of diseases, biostatistics, and research ethics) | |
| https://www.icrweb.jp/course/show.php?id=3 | |||
| GCP Training (Version compliant with R2) | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Good Clinical Practice, differences in the organizational frameworks between ICH-GCP and J-GCP | ||
| https://www.icrweb.jp/course/show.php?id=2 | |||
| JCOG Clinical Trial Seminar - Introductory Course | Mindset required to conduct clinical trials (such as statistics, clinical trial design, evaluation of efficacy and adverse event, subject protection and research ethics, monitoring, clinical trial types, and regulations) | ||
| https://www.icrweb.jp/course/show.php?id=4 | |||
| Preparation Course for Principal Investigators in Clinical Research | Regulatory requirements and incorrect situations regarding clinical research, approaches to investigator-initiated clinical trials, tasks and shared responsibilities between researchers and support departments, key points when conducting clinical trials under advanced medical systems, etc. | ||
| https://www.icrweb.jp/course/show.php?id=67 | |||
| Methodologies in Clinical Research (Designs, Protocols, etc.) | Protocols and Publications | Creation of clinical research protocols and research concepts, how to write publications, publication ethics, etc. | |
| https://www.icrweb.jp/course/show.php?id=10 | |||
| Creating Research Frameworks (In the Psychiatric and Neurological Fields) | Creation of research frameworks, which are the foundations for proposals, and planning of patient-oriented research (including PECO/PICO to transform clinical questions into research questions, modeling questions, basics of research design and biostatistics, outcome design, etc.) | ||
| https://www.icrweb.jp/course/show.php?id=86 | |||
| Methodological Topics in Clinical Research | Methodologies in clinical research (including meta-analysis, medical economic evaluation, Bayesian approaches, real-world data, data sharing, etc.) | ||
| https://www.icrweb.jp/course/show.php?id=13 | |||
| Practice of Clinical Trials that Incorporate PRO/QOL Assessments | Protocol creation, questionnaires, assessment methods, etc. in clinical research assessing QOL (Quality of Life) in the PRO (Patient Reported Outcome) format | ||
| https://www.icrweb.jp/course/show.php?id=19 | |||
| 2022 Training for Personnel in Clinical Research and Trials (NCCHE) | Regulatory requirements and guidelines regarding clinical trials using real-world data, actual clinical trials using real-world data, monitoring, basic knowledge of statistics related to cancer clinical trials, etc. | ||
| https://www.icrweb.jp/course/show.php?id=50 | |||
| NC/JIHS: Lipidomics Course (JIHS) | Overview of lipidomics, specimen preparation, lipid analysis using liquid chromatography mass spectrometry (targeted analysis, non-targeted analysis), etc. | ||
| https://www.icrweb.jp/course/show.php?id=73 | |||
| NC/JIHS: Intellectual Property Seminar | Required information for medical researchers, such as patent rights, copyrights, tangible research results, etc. | ||
| https://www.icrweb.jp/course/show.php?id=80 | |||
| Monitoring, Data Management, etc. | NC/JIHS: Clinical Research Monitoring and Data Management Course (NCNP) | QMS (Quality Management System), RBA (Risk Based Approach), QbD (Quality by Design), monitoring types/flow/task allocation, etc. | |
| https://www.icrweb.jp/course/show.php?id=76 | |||
| Clinical Research Data Management Introductory Course 1 | Overview of CDM (Clinical Data Management), database basics, CRF (Case Report Forms) design, etc. | ||
| https://www.icrweb.jp/course/show.php?id=14 | |||
| QMS Regarding Medical Institutions | Incorporation of the QMS system in accordance with the 2023 ICH-GCP revision, introduction to QMS systems in domestic and overseas medical institutions, QMS desired by companies, etc. | ||
| https://www.icrweb.jp/course/show.php?id=46 | |||
| QMS Regarding Medical Institutions 2 | Introduction of QMS systems in domestic and overseas medical institutions, etc. | ||
| https://www.icrweb.jp/course/show.php?id=48 | |||
| Initiatives Regarding the Implementation of the Risk-Based Approach (RBA) | RBA positioning, significance, necessity in ensuring clinical research quality, seven steps of RBA, etc. | ||
| https://www.icrweb.jp/course/show.php?id=26 | |||
| Training on the Concept of RBA Towards the Implementation of QMS | Overview of QMS and RBA, QMS and RBA case examples from medical institutions excluding core clinical hospitals | ||
| https://www.icrweb.jp/course/show.php?id=49 | |||
| NC/JIHS: Clinical Research Course (NCGG) | Important clinical research monitoring points, including the development of monitoring plans with reference to the “Ethical Guidelines for Medical and Biological Research Involving Human Subjects” and “Clinical Trials Act” | ||
| https://www.icrweb.jp/course/show.php?id=78 | |||
| Research Ethics/IRB | Course for Framework Development at Clinical Research Institutions | Roles of IRB (Institutional Review Board) staff, central IRB, consignment and entrustment of reviews, clinical research insurance, IRB statuses from the public point-of-view, significance of public representatives involved in IRBs, etc. | |
| https://www.icrweb.jp/course/show.php?id=85 | |||
| Course on Subject Protection and Research Ethics | Conflict of interests, patient and public involvement in clinical research, patient representatives in ethics review boards, use and protection of personal information, prevention of research misconduct, etc. | ||
| https://www.icrweb.jp/course/show.php?id=82 | |||
| NC/JIHS: Clinical Research Course (JIHS) | Case examples of clinical research misconduct, audits (laws and guidelines), the role of principal investigators, differences between monitoring and audits, case examples of audit findings, etc. | ||
| https://www.icrweb.jp/course/show.php?id=70 | |||
| PRIMO Research Ethics Workshop for FY2019 | Act on the Protection of Personal Information, Clinical Trials Act, fairness in clinical research, clinical research insurance (liability/coverage), etc. | ||
| https://www.icrweb.jp/course/show.php?id=53 | |||
| Research Ethics Lessons from Case Studies (Shiga University of Medical Science) | Key points for ethical consideration in clinical research: Validity of placebo-controlled trials, subject risks, measures to mitigate risks, informed consent, research ethics, etc. | ||
| https://www.icrweb.jp/course/show.php?id=68 | |||
| Informed Consent | Informed Consent in Regenerative Medicine Research | Basic elements of informed consent, points of caution, subject protection, confirmation of eligibility, etc. | |
| https://www.icrweb.jp/course/show.php?id=83 | |||
| Patient and Public Involvement | The 3rd JCOG Patient and Public Seminar Program | PPI (Patient and Public Involvement), patient/public seminar “Overview of Cancer Treatment,” “Clinic Trial Case Examples,” “Clinical Trials and Treatment Development,” “Concepts Unique to Clinical Trials,” etc. | |
| https://www.icrweb.jp/course/show.php?id=87 | |||
| Introductory Lesson to “Patient and Public Involvement in Research” | PPI concepts, basic knowledge, and communication methods/points of caution regarding PPI activities | ||
| https://www.icrweb.jp/course/show.php?id=91 | |||
| Other | Clinical Trial Support by CRCs of Participating JCOG Institutions | Case examples of CRC (clinical research coordinator) support within investigator-initiated clinical trials at participating institutions of JCOG (Japan Clinical Oncology Group) | |
| https://www.icrweb.jp/course/show.php?id=84 | |||
| NC/JIHS: Antimicrobial Resistance (AMR) Course (JIHS) | Current status and future outlook for AMR (antimicrobial resistance) countermeasures, surveillance systems, public education and awareness activities, MRSA (Methicillin-resistant Staphylococcus aureus), etc. | ||
| https://www.icrweb.jp/course/show.php?id=90 | |||
| 6NC: Pediatric Medical Research Course (NCCHD) | Use of unapproved drugs/off-label drugs in pediatric care, necessity for clinical development and clinical trials of pharmaceuticals and medical devices, points of caution in this regard, etc. | ||
| https://www.icrweb.jp/course/show.php?id=77 | |||