Medical Corporation Heishinkai Staff Education
Heishinkai provides regular employee trainings to all clinical staff with the aim to ensure subject protection, data authenticity and smooth study conduct.
Regular GCP Training
GCP training is regularly conducted once every two years, and as needed when there are any GCP amendments. Training materials is “CROCO”, an e-learning site for education on clinical research provided by Osaka University Hospital.
For J-GCP, training is conducted through self-learning using training materials, and a “J-GCP Training Record” is created after the training is completed. For ICH-GCP, staff participate in “CROCO” ICH-GCP training. Upon completion, “Certificate of Completion” is issued and archived.
Pre-Trial Meetings
Start-Up Meeting
Prior to study start, start-up meetings are held. Sponsor and study team including investigators, CRCs, study nurses, pharmacists, and lab technicians present on and discuss about trial-related information such as study planning, potential risks and mitigations, protocol outline, characteristics of the investigational drug, and study schedule.
Study Site Meeting
To ensure study procedures are carried out per schedule and in compliance with the protocol, site personnel of each department meet to present on and discuss about trial information such as study flow between visits and inter-department collaborative procedures and cautions.
On-Site Training
Compliance Training
Compliance training is continuously enforced. All employees are mandated to take compliance training once every two years. Training content is based on real non-compliance cases. In addition, compliance training related to clinical trial support services is also held once a year for clinical staff. The trainings focus on the concept of ‘misconduct-free’. We also have a system in place to facilitate reporting on misconduct or suspected misconduct.
Personal Information Protection and Information Security Training
Training on personal information protection and information security is provided to all employees every year. For the personal information protection training, the latest cases of personal information leakage are used and highlights of Personal Information Protection Law revisions are explained to ensure employee awareness of the importance of personal information protection, their role in protecting personal information, and the consequences of violating personal information protection, so that each and every employee can take the right actions. For the information security training, the latest cases of information leakage and the “10 Major Threats to Information Security” published by the Information-technology Promotion Agency of Japan are used to raise awareness on risk recognition and countermeasures.
New Employee Onboard Training & Continuing Education
New employee onboard training includes more than 40 hours of pertinent basics essential for their role and job duties.
Upon completion of new employee onboard training, on-the-job training (OJT) is provided by OJT trainers who have received OJT trainer trainings from qualified external sources.
| New employee basics |
| Pharmaceuticals and Medical Devices Act, GCP and Clinical Research Act |
| Clinical trial ethics |
| Drug development process |
| Clinical trial infra and conduct |
| Clinical trial support services and the role of CRC |
| Significance of SOP |
| Communication skills |
| Clinical trial protocols |
| Investigator’s Brochures |
| Clinical trial basics (lab tests, clinical pharmacology studies, etc.)) |
| Informed consent |
| Record keeping |
| SOP |
For knowledge maintenance and improvement, the following continuing education sessions are:
| Medical safety management |
| Prevention of in-hospital infections |
| Diseases and therapeutic drugs |
| GCP and other relevant regulatory revisions |
| Clinical trial basics |