Procedures for clinical trials (2): from application to completion of the trial

Standardized application forms

The UHCT Alliance has unified application forms, so sponsors can prepare forms efficiently. Please apply directly to the office of each member and discuss with the staff any possible problems peculiar to that trial site.
Schedules after application are somewhat different among the members of UHCT Alliance.
We provide the schedules of each member on our homepage (http://plaza.umin.ac.jp/~UHCTA/index.html).

Institutional Review Board

Please click here for standard timetables of the IRB in each member hospital.

Contract

Please click here for standard timetables from IRB to contract in each member hospital.  Please contact the administrative office of each member individually for the forms and contents of contracts.

CRC liaison council and staff meetings

CRC liaison council has held staff meetings of solving some problems under the circumstances for CRC staff and office staff on each UHCT alliance university. Especially, in collaboration seminar hold forth by pharmaceutical industry, we can get not only the international situation but also appropriate attitude as medical institutions with global standard, and some hints for everyday work with confidence. By using TV meetings, we can link all together, whether our staffs are very busy and our universities are distributed over a wide area. It is popular that cooperative traning style with very fresh information and provide dynamic discussions by fascinating teachers, several times a year. We promote UHCT alliance's qualitative repletion through we learn together.

Improving progress committee

UHCT alliance treats contracted clinical trial as all constracted hospitals pull together and aim to complete it. It is intended that collaborated protocol's CRC staff as promoter share successful cases of practice over hospitals, and promote the approach for FPFV ( First Patient First Visit ). They have educational approach for CRC's upskilling program in practical science, e.g. cases of prompt entry for clinical trial, ingenuities to solve practical problems, and so on. Clients can attend our TV meeting system on each favorite university.

Start-up meeting

Please arrange the schedule for the start-up meeting with the CRC in charge of the clinical trial at each site.

SDV, Monitoring, and Safety Reports

All member hospitals have dedicated space for SDV and trial monitoring, and sponsors can apply to use it whenever they wish to visit. On-demand SDV and monitoring is available at no extra charge. Please inquire of the administrative office at each member hospital for details. Sponsors can use the video-conference system to explain their safety reports.