What is international Clinical Research Professional ?

As noted in the development of the COVID-19 vaccine, in order to deliver better treatments to patients more quickly and widely, there is a growing need for international joint clinical research and trials in multiple countries and regions. Clinical research specialists with common research ethics and knowledge are essential for multicenter clinical research. PIs, CRCs, and data managers, among others, all play a role in it . In international joint clinical research, there are differences between countries in various systems such as medical systems, research systems, and laws related to clinical research. In addition, especially in low-income countries in Asia and Africa, the clinical research system itself has not yet been established. For this reason, there are also issues in terms of hardware and software, such as a shortage of research facilities, researchers, and research supporters. As a first step toward solving these problems, we need to create a system (training system) that enables people to learn basic knowledge about clinical research, basic ethics, and rules such as ICH-GCP, regardless of country or language. is required. In addition, a mechanism (certification system) to certify the system in a fair and impartial manner is necessary.

Therefore, we will ensure that individuals have acquired the knowledge necessary for international joint clinical research, conduct a fair, impartial and international evaluation, and certify them as an "international clinical research professional (iCRP)". The future work of iCRPs certified under this system is expected to improve the quality of international joint clinical research, promote standardization (harmonization), and further expand research promotion. We believe that this will lead to the promotion of problem-solving in the global health field.

About the “International Clinical Research Professional” Certification System

To conduct international joint clinical research in multiple countries and regions, it is important to ensure the protection of subjects, integrity of data, and reliability of the results. The "iCRP Certification System" was established to objectively evaluate the acquisition of such research ethics and continuous learning. This system was planned and constructed by the AMED Asian region clinical research and clinical trial network construction project (starting in 2020). The International Society of Clinical Medicine operates as the certification organization. The organization certifies new occupations and industries necessary for the promotion of international clinical medicine, such as medical interpreters and Japanese international nurses. The International Society of Clinical Medicine has set up an "International Clinical Researcher Certification Subcommittee" consisting of members from inside and outside the society, and conducts certifications based on a fair and impartial screening.

＊What are the benefits of certification under this system?
First, each country has a qualification/training system for clinical research, but there is no other qualification/training system for international joint research spanning several countries or regions. The strength of these courses is that they can be taken online, so applicants can take them from anywhere in the world. Second, by obtaining accreditation under this system, individuals can prove that they have the knowledge, skills, and abilities necessary to conduct ethical and responsible clinical research required of experts involved in clinical trials. Also, they can improve their level by continuing. In the future, we plan to collaborate with the authorities and academic societies of each country and conduct mutual recognition with similar overseas certification systems.

・Certification system rules

About the certification method for the "International Society of Clinical Medicine International Collaborative Researcher"

Eligibility Requirements

Target audience –
Those who engage in or support international joint clinical research in Japan or overseas (including both domestic clinical research and international joint clinical research).

Examples: individuals involved in clinical research, including CRCs (clinical research coordinators), researchers, epidemiologists/biostatisticians, clinical pharmacologists, physicians, dentists, pharmacists, nurses, clinical research-related companies, and regulatory authorities

Eligibility –
Experience in one or more clinical research projects* or one year or more *Includes both domestic clinical research and international joint clinical research

Flow of certification

1.Joining the International Society of Clinical Medicine ＜Online＞
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2.Application for Training ＜Online＞
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3. Start taking courses via e-learning ＜Online＞
　　Complete the program within two years from the start of training. ＜Online＞
　　Passing the written test (confirmation test) ＜Online＞
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4.Participation in the International Society of Clinical Medicine iCRP certification training course.
　 Attend one or more workshops within two years from the start of training.
　 Online attendance is permitted.
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5.Report on the above class content and apply for certification ＜Online＞
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6.Certification issued after passing screening.

About the certification application

Certification period: Once a year (receipt of applications around January, screening around February, notification around March, certifications issued starting in April)

●Certification registration fee.
・Academia (universities, research institutes)：20,000yen
・Non-academia (private companies)：40,000yen

Renewal

Certification period: 4 years

・Flow of renewal
①Attend a researcher certification seminar held by the International Society of Clinical Medicine at least once every four years (in person or online).
②Full payment of the membership fee of the International Society of Clinical Medicine.
③Apply for certification renewal ＜Online＞

Loss of certification

・Loss of society membership
・Failure to renew certification

Office procedure

①Application for full membership of the International Society of Clinical Medicine ＜Online＞.
　　Submit the necessary information on 　the membership application webpage.

②Application for training ＜Online＞
　　Submit the necessary information on 　the training application webpage.

③Take the e-learning program. ＜Online＞
　　After confirming the contents of the training application, we will send you an e-learning program usage guide by e-mail.
　　Read the usage guide carefully and take the e-learning program.

④Designated seminar.
　　Please check the details on 　the seminar webpage.

⑤Application for certification
　　Enter the required information on 　the certification application webpage, 　attach the required document image file, and submit.

　●Required Documents
　 　・Documents that can prove clinical research experience (image data).
　　　(Documents such as protocols that clearly indicate the name of the applicant and confirm the conduct of the clinical trial.)
　 　・Certificate of qualification for clinical research (image data).
　 　・Certificate of participation in international clinical research version training using the e-learning system designated
　　　 by the Society (image data).
　 　・Certificate of participation in designated seminars (image data).

⑥Renewal of application (after 4 years)
　　　Submit the required information on the renewal application webpage (under construction)
　　　and attach the required document image file.

Payment procedure

・Regular member annual fee ：5,000yen ＋ overseas fees 500yen ・Designated seminar fee ：10,000yen
・Certification registration fee：Academia (universities, research institutes) ‐ 20,000yen, Non-academia (private companies) ‐ 40,000yen
・Renewal fee ：(universities, research institutes) ‐ 20,000yen, Non-academia (private companies) ‐ 40,000yen

　Japan → bank transfer, 　overseas → credit card payment (PayPal payment)

■Credit payment (PayPal payment) (Only payments from overseas are supported)

Credit payment webpage link

Contact information

icrp-info@kokusairinshouigaku.jp