In Kyushu University Hospital, it is mandatory for the manager or principal investigator of every interventional study involving invasive procedures (including investigator-initiated clinical studies) to obtain Clinical Research Association certification and PI certification (senior level course of clinical research associate certification program).
“Ethical Guidelines for Medical and Health Research Involving Human Subjects” and “Ministerial Ordinance on Good Clinical Practice for Drugs”, etc. formulated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and MHLW also strictly specify the responsibilities of the manager or principal investigator of the study. Therefore, it is essential to conduct interventional studies involving invasive procedures (including investigator-initiated clinical studies) after thoroughly understanding the duties.
This program is meant for instructors, physicians (interns), nurses, pharmacists, various technologists and others who participate in clinical research projects. Students at the graduate and post-graduate levels who may be associated with the implementation of clinical research projects are also required to obtain this certification.
The instructors teaching various courses where the students might take part in clinical research projects must encourage the students to obtain this certification.
Even persons outside the Kyushu University who take part in clinical research conducted at the Kyushu University Hospital are required to obtain this certification.
The “Clinical Research Associate Certificate” is conferred after the candidate takes a new “Certification Course for Clinical Research Associate” held 4 times in a financial year (twice each in the first half and the second half) and obtains passing marks in the certification tests. This course is held every year approximately during April-July in the first half and October-January in the second half of the financial year. The course will be announced through users’ mail of Kyushu University employees about one month before its start. However, such notifications may not be sent to students. So the instructors must inform their students.
A “certificate” is issued to a person who becomes eligible for “Clinical Research Associate Certification”. This certificate is valid for life and should be kept with care.
The names of the person and certification number are printed on the certificate and it takes some time for it to be issued. The issue of the certificate should be taken as communication of the certification number. The certification number is required for applying for IRB examination of clinical research projects at the Kyushu University Hospital. Those who wish to find out their certification number before the certificate arrives at their address may inquire at CCTR or with research support personnel at the Strategic Planning Section.
If someone requires reissue of the certificate because of loss or damage of the original, contact CCTR or research support personnel at the Strategic Planning Section, or make a request at the reception window of the certification course (for both new and renewal courses).
The reissue may take some time as the certificate will be printed at the usual time of printing of new certificates.
The original certification number is retained. A new number is never given when a certificate is reissued.
If someone moves out of Kyushu University due to transfer, etc., which invalidates the original certificate, it is not necessary for the person to take the new certification course a second time. The holder of the certificate must communicate his or her situation at the certification renewal window when joining the “Certification Renewal Course”. The original certification number is retained. A new number is never given when a certificate is reissued.
This course is meant for managers of clinical research projects or the principal investigators of clinical trials who will be planning and executing interventional studies involving invasive procedures (including investigator-initiated led clinical studies) at the Kyushu University Hospital. Apart from this, any person who would be associated with an interventional study involving invasive procedures (including investigator-initiated clinical studies) are also the targets of this course. Furthermore, persons who are associated with the aforesaid kinds of work in other universities and institutions are also eligible.
Note: This certification is not essential for principal investigators of sponsor-initiated clinical studies. However, as the duties and responsibilities are similar, it is advisable for them to take this course as far as possible.
”PI certificate” is conferred after the candidate takes the “Course for New PI Certification” each session of which lasts about 5 hours and passes the certification test with eligible marks. This course is held 4 times in a financial year (twice each in the first half and the second half).
This course is held every year approximately during April-July in the first half and October-January in the second half of the financial year. The course will be announced through users’ mail of Kyushu University employees about one month before the start of the course.
However, only Kyushu University employees are eligible for the certification. Only a “Course Completion Certificate” will be issued to those from outside the university.
Those who qualify for PI certification will receive a “PI Certificate (seal)” or “Course Completion Certificate”. The PI certificate is valid for life and must be handled with care.
The PI certificate is used by affixing it in the “Clinical Research Associate Certificate” field. It takes some time for the certificate to be issued after the person qualifies. The “PI Certification Number” consists of the “Clinical Research Associate Certification Number plus a symbol”.
The PI certification number of the manager of the study or the principal investigator is required for applying for IRB examination of interventional studies involving invasive procedures (including investigator-initiated clinical studies) done in this hospital.
If someone requires reissue of the certificate because of loss or damage of the original, contact CCRT or research support personnel at the Strategic Planning Section of the Center, or make a request at the reception window of the certification course (for both new and renewal courses).
The reissue may take some.
The original certification number is retained. A new umber is never given when a certificate is reissued.
The “PI certification” is valid only for the financial year in which it is issued.
For renewing the certification one must undergo a course (PI Certification Renewal Course certified by CCTR) at least twice in a financial year. The course details are communicated to University employees through the user’s mail as soon as they are decided.
If CCTR assesses that a certain course is useful for implementing interventional research projects involving invasive procedures (including investigator-initiated clinical studies), CCTR recognizes it as equivalent to a PI Certification Renewal Course even if the course is organized by a department other than CCTR. Therefore, the Center CCTR may be consulted while organizing such courses or training sessions.
A grace period of a full financial year following the financial year of the certification or its latest renewal is provided to prevent expiry of the certification. Therefore, we request the certificate holders to attend a renewal course within this period. We recommend that the course may be availed as early as possible as generally there are more participants in the second half of the financial year and the numbers of courses available also become limited.
When the certification becomes invalid, by the person moving out of Kyushu University because of transfer, etc., one need not undergo the new certification course again. One may simply inform at the certification renewal window about the situation at the time of joining a certification renewal course.
The original certification number is continued after the renewal and a new number is never issued.
The certification program will be implemented from April 1, 2016. Financial year 2015 will be regarded as the transition period during which persons who do not have this certification can become a manager or principal investigator of any interventional study involving invasive procedures (including investigator-initiated clinical studies) as earlier. However, this transitory measure will not be applicable from the financial year 2016 onwards. Such investigators must obtain PI certification during the financial year 2015.
Courses on PI certification (new and renewal) planned for the future
Contact
Please contact CCTR (Extension: 5080) or research support personnel (Extension: 5082) in the Strategic Planning Section of Kyushu University Hospital for any queries on this certification program.
