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Clinical Research Support Office

Akihiro Sato, Miki Fukutani, Sakiko Kuroda, Takako Tomizawa, Kayo Toyosaki, Masako Nakamoto, Kana Fukui, Masato Yonemura, Hiromi Hasegawa, Yoshihiro Aoyagi, Seiko Matsuda, Kaori Tobayama, Ayako Sugama, Tsukiko Higuchi, Wataru Okamoto, Akiko Nakayama, Izumi Miki, Tomohisa Sudo, Yuuko Tagami

Introduction

The Research Management and Data Management Section supports the investigator-initiated clinical trial program in the NCCHE though the clinical datacenter, study management, site visit monitoring, safety information management, and bio statistics.

The Bio Bank and TR Support Section supports Translational Research including a genome-wide screening network program through study management and data management.

Routine activities

Data Management Section

  • -Database and CRF form design
  • -Registration
  • -Data management
  • -System administration
  • -Bio statistics

Research Management Section

  • -Study management
  • -Site visit monitoring
  • -Safety information management
  • -Medical writing

Bio Bank and TR Support Section

  • -Study management for TR
  • -Data management for TR
  • -Research concierges for Bio Bank

Clinical trials

Data Management and Research Management sections

  • -In 2015, five IND trials started enrollment.
  • -A total of 86 patients were enrolled Bio Bank and TR Support Section
  • -In 2015, five TR trials were conducted.
  • -A total of 1,783 patients were enrolled

Education

On-the-job-training for new staff.

Support the education program for clinical trial methodology and GCP in the NCC.

Co-host the GCP training seminar with other ARO.

Future prospects

Preparation for conducting global IIT IND trials.