Preparation of draft plan for providing regenerative medical care

1. Project for providing regenerative medical care (MHLW Form 1)
   Document preparation support site: https://saiseiiryo.mhlw.go.jp/application/plan (in Japanese)
2. Document giving details of the regenerative medical care to be provided
3. Document giving names, designations, organizations and brief biodata (summary of research achievements, etc. if available) of the manager of the project and the physician/dentist who will provide the regenerative medical care.
4. Informed consent form for donors of cells
5. Informed consent form for recipients of regenerative medical care
6. Document describing results of research on the cells that will be used for the regenerative medical care.
7. Data from within and outside the country on the status of use (research results and the like) of the regenerative medical care that is the same as or similar to the proposed care
8. Brochure on the specific processed cells, standard code of the specific processed cells, sanitation control standard code, manufacturing control standard code and quality control standard code
9. Document giving particulars mentioned in the package insert, etc. of the product to be used for the regenerative medical care, if the product is to be used irrespective of its approved usage details
10. Document giving details about the regenerative medical care in as simple and easily understood language as possible
11. A copy of the commissioning contract if the production of specific processed cells product is to be commissioned
12. Rules for handling personal information
13. Others

Preparation of measures for compensating subjects for any damage to their health

Arrange for suitable compensation measures such as enrollment in a clinical research insurance scheme for regenerative medical care.
Any such insurance cover contract should be signed before the start of providing regenerative medical care, etc.

Window for insurance cover estimation and procedure for obtaining such cover (only for Kyushu University):
Sasahara, Strategic Planning Section, Kyushu University Hospital (extension: 5082)

Note: Those outside the Kyushu University may enquire about the insurance cover at their respective institution, or consider subscribing to a suitable insurance scheme like “Regenerative Medical Care Clinical Research Compensation Insurance Scheme” initiated by the Japanese Society for Regenerative Medicine.

Application for preliminary examination

• A preliminary examination is essential for any clinical research led by Kyushu University researchers (multicenter research projects the protocol for which has been prepared outside the Kyushu University are excluded). Preliminary examination of clinical research led by researchers outside the university is done if there is a request for it.

  Note: What is preliminary examination?
  Preliminary examination is an examination by experts from CCTR and the 100-member panel before the application is sent to the Specially Certified Committee for Regenerative Medicine. They offer general advice on preparation and implementation of the protocol (support for scientific rationality, biostatistics, and preparation of the informed consent form).

Submission of documents for preliminary examination

Download the following forms to prepare the documents

1. Request for preliminary examination
2. Application
3. Self-check sheet for application to the committee
4. Standard check-list for providing regenerative medical care (MHLW)
5. Reports on any conflicts of interest as and when they arise
6. Document on expenses payable as examination fees (only for Kyushu University)

Submit one copy each of the following documents for preliminary examination.

1. Request for preliminary examination
2. Application
3. Self-check sheet
4. Reports on any conflicts of interest as and when they arise
5. Document on expense payable as examination fees (only for Kyushu University)
6. Draft plan for providing regenerative medical care and any attached document.
   Note: See “1. Preparation of project for providing regenerative medical care”

⇒ Submit to: CCTR (Strategic Planning Section, 5 F Outpatient Building, Kyushu University Hospital)
TEL：092-642-5082 (Extension 3771)
E-mail：bynintei@jimu.kyushu-u.ac.jp

Preliminary examination

After deciding a suitable date and time, the preliminary examination is done in about 1 hour.
Any doubt or issue about details of the project is deliberated in the preliminary examination.
The documents for application to the Specially Certified Committee for Regenerative Medicine must be finalized on the basis of results of the preliminary examination.
Conflict of interest issues are examined in the preliminary examination. However, the Conflict of Interest Management Committee for Clinical Research is consulted if additional discussion is considered necessary.

Application to the Specially Certified Committee for Regenerative Medicine

• The last day of the month previous to the month of the committee meeting is the deadline for application. The committee meeting is held within one month after the application is accepted.
  ⇒ Send application documents to:
  General Affairs, Strategic Planning Section, Kyushu University Hospital
  3-1-1 Maidashi, Higashi-ku, Fukuoka 〒812-8582
  TEL：092-642-5079 FAX：092-642-5008
  Note: Please inform byshasiwatas@jimu.kyushu-u.ac.jp beforehand the date and time of submitting the application.
• An e-mail confirming the date and time, venue, presenter and associate attendees will be sent to the applicant about 2 weeks before the scheduled meeting of the Specially Certified Committee for Regenerative Medicine.

Documents for applying to the Specially Certified Committee for Regenerative Medicine

• Download one of the forms shown below to prepare the request for examination.
  ·”Request from within Kyushu University for examination by the committee for regenerative medicine” (in Japanese)
  ·”Request from outside Kyushu University for examination by the committee for regenerative medicine” (in Japanese)
• Submit the “application” and “document on expense payable as examination fees (only for Kyushu University” that had been submitted at the time of the preliminary examination, and one copy each of the documents listed below along with the aforesaid request.
  1. Project for providing regenerative medical care (MHLW Form1)
     Document preparation support site: https://saiseiiryo.mhlw.go.jp/application/plan (in Japanese)
  2. Document giving details of the regenerative medical care to be provided
  3. Document giving names, designations, organizations and brief biodata (summary of research achievements, etc. if available) of the manager of the project and the physician/dentist who will provide the regenerative medical care.
  4. Informed consent form for donors of cells
  5. Informed consent form for recipients of regenerative medical care
  6. Document describing results of research on the cells that will be used for the regenerative medical care.
  7. Data from within and outside the country on the status of use (research results and the like) of the regenerative medical care that is the same as or similar to the proposed care
  8. Brochure on the specific processed cells, standards for the specific processed cells, documented hygiene management standards, production management standards and quality management standards
  9. Document giving particulars mentioned in the package insert, etc. of the product to be used for the regenerative medical care, if the product is to be used irrespective of its approved usage details
  10. Document giving details about the regenerative medical care in as simple and easily understood language as possible
  11. A copy of the commissioning contract if the production of specific processed cells product is to be commissioned
  12. Rules for handling personal information
  13. Others

Payment of the fee for examination by the Specially Certified Committee for Regenerative Medicine

• How the University collects the examination fee
  [Researchers from Kyushu University]
  Make payment to the person in charge of the concerned department from the specified source.
  [Researchers from outside Kyushu University]
  A “Contract concerning the examination work, etc. of project for providing regenerative medical care” is to be signed after submitting the application documents to the Specially Certified Committee for Regenerative Medicine.
  A bill will be issued based on this contract.
• Examination fees

  	Within the University	Outside the University
  New examination	¥237,000	¥387,000
  Re-examination	¥142,000	¥219,000
  Report	-	¥1,300

• The Committee meets at a suitable time and date when there is a request for examination.
• The presenter must explain the case within 15 minutes (adhere strictly to this time limit) based on the application documents submitted. A slide presentation, etc. is not required.
• The result of the examination will be sent to the manager of the project (the clinical research coordinator (CRC) in the case of a multicenter research project) within 1 month from the committee meeting as a “Statement of the Certified Committee for Regenerative Medicine” (Attached Form 5).

Submission of project for providing regenerative medical care

• After approval by the Specially Certified Committee for Regenerative Medicine, the manager of the project (the CRC in the case of a multicenter research project) must submit the project for providing regenerative medical care to the Minister of Health, Labor and Welfare or the Chief, Regional Bureau of Health and Welfare. Use the website http://saiseiiryo.mhlw.go.jp/ (in Japanese) for the application.
• The documents to be submitted include the protocol for providing regenerative medical care approved by the Committee (Form 1) and documents appended to it, and the Statement of the Certified Committee for Regenerative Medicine.
  The project for providing regenerative medical care (Form 1) requires the official seal of the administrator of the institution where the regenerative medical care would be provided. In cases where the project will be implemented within Kyushu University, the document, with the seal of the Director, Kyushu University Hospital is sent to the manager of the project along with the Statement of the Certified Committee for Regenerative Medicine.

Registration of the clinical study

• Clinical study registration is required when regenerative medical treatment is to be given as a part of clinical research.
  There are some clinical study registration sites which include those listed below. Clinical study-related information must be registered before starting the study and updated as the study progresses.
  

  [Japan (it is essential to register at one the sites listed below)]

  ·UMIN (http://www.umin.ac.jp/)

  ·Japan Medical Association (http://www.med.or.jp/)

  ·Japan Pharmaceutical Information Center (http://www.japic.or.jp/)

  [USA]

  ·Clinical Trials gov. (https://clinicaltrials.gov/)

• Start clinical research and treatment only after acceptance of the notification of the project for providing regenerative medical care.
  Apart from observing and evaluating the study subjects, the following reports must be submitted to the Specially Certified Committee for Regenerative Medicine during implementation of the project.
  ·Reports on changes, etc. in the plan of the project for providing regenerative medical care, etc.
  ·Adverse event reports
  ·Periodical updates

• Organize the necessary records and file them for storing

  Particulars to be recorded:

  ·Name, gender, date of birth and address of the persons who received the regenerative medical care

  ·Name of the disease and main symptoms

  ·Types of specific processed cells, etc. used, methods of their administration, and other details of the regenerative treatment and the evaluation.

  ·Information concerning the cells used for the regenerative medical treatment (source of procurement, results of tests, etc.).

  Duration of storage:

  ·30 years for records concerning the regenerative medical treatment wherein the either the specific regenerative medicine product or specific processed cells made from raw materials similar to the raw material of the specific regenerative medicine product

  ·10 years for other records