Clinical Study

Work flow of the procedures of contract research

New procedures for clinical trials and post-marketing clinical studies

Make an appointment for the preliminary hearing as we conduct preliminary hearings at least 2 weeks before the date of planned application to IRB.
Tel: 092-642-5924 (Pharmacist, Clinical Research Office)

Beforehand… (can be sent by post) Trial protocol
  • Investigator’s Brochure
  • Informed Consent Form
  • Case Report Form (CRF) (if needed)
  • Investigational Product Management SOP
  • Others
  • Daily Records of Patients, Cost Calculation Document, Points Table

Beforehand… (can be sent by e-mail) Preliminary data for pre-hearing
  • Draft of changes in the contract (Kyushu University format)

All documents must be in the uniform format or the Kyushu University format.

http://www.med.kyushu-u.ac.jp/crc/chiken/shinsei.html (in Japanese)

Note: These must be completed at least 2 weeks before the planned application

Pre-hearing

The following data is exchanged so that it can be finalized after the pre- hearing and before processing of the application: “Management data”

Application for examination by IRB (closed at the end of each month, in principle)

Ensure that you have an appointment for the date and time for making the application.
Tel: 092-642-5774 (General Affairs, Clinical Research Office)

In principle, the last day of the month (31st) is the deadline for receiving applications in that month.
(Example) Applications made during July 1 to July 31 are examined by IRB in August.

E-mail consultations regarding the contract document are done by the Contracts-in-Charge of the office.

Confirmatory e-mails about the date, time and venue of the IRB meeting and the names of the presenter and associates would be sent 1-2 weeks before the meeting. Be in touch with the concerned physician regarding these matters.

IRB (4th Thursday of each month)

In principle, only continued examinations will be taken up in March.

The result of the IRB examination and any specific aspects pointed out will be communicated by e-mail. Find a suitable date for holding the startup meeting with the CRC concerned.

Prepare the case files.

Signing of the contract

Make appointment beforehand for the date and time of delivery of the investigational product.
Tel: 092-642-5924 (Pharmacist, Clinical Research Office)
(Prepare receipt and return forms for the investigational product in the format of the sponsor.)

A bill will be issued. Make payment within 30 days (including Saturdays, Sundays and holidays) from the date of issue of the bill.

Startup meeting (investigating physicians, CRC, sponsors and others attending)
Implementation of the clinical study
Completion of clinical study

New procedure for post-marketing surveillance

In case of new formulations, the proposal for appointment should be made, as there will be some aspects that need to be verified.
Tel: 092-642-5924 (Pharmacist, Clinical Research Office)

Examination by IRB is necessary for surveillance that involves patients’ consent. Therefore, please consult well in advance in such cases.

Use the uniform format or the Kyushu University format for preparing the different documents.

http://www.med.kyushu-u.ac.jp/crc/chiken/shinsei.html (Japanese website)

Prepare a modified draft of the contract document if it is felt that some details in the contract template need to be changed. In such cases remember to invariably keep a track record of changes in the MS Word document.

Contact us if you need any clarifications or prior confirmation about the details to be included in the application form.

Note: All these need to be completed before submitting the application.

Prior confirmation
Submission of application

Contact person ⇒ Tel: 092-642-5774 (General Affairs, Clinical Research Office)

Signing of the contract

A bill is issued after the contract is signed.
Make payment within 30 days (including Saturdays, Sundays and holidays) from the date of issue of the bill.

Execution of the surveillance
Conclusion of the surveillance