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Safety content examination and deliberation in international medical center of Japan

  • At: 2008 FIP Congress in Basel (Switzerland)
  • Type: Poster
  • By: SAKAMOTO, Yuka (International Medical Center of Japan, Tokyo, Japan)
  • Co-author(s): Kubota, Atsushi (International Medical Center of Japan, TOKYO, Japan)
    Atsuta, Kazuyoshi (International Medical Center of Japan, TOKYO, Japan)
    Yoshino, Nobutsugu (International Medical Center of Japan, TOKYO, Japan)
    Okazaki, Osamu (International Medical Center of Japan, TOKYO, Japan)
    Uemura, Naomi (International Medical Center of Japan, TOKYO, Japan)
    Kondo, Naoki (National Cancer Center, Japan)
  • Abstract:

    When I observe a serious adverse event regarding the investigational product, the sponsor promptly notifies the head of the trial site and an investigator. The head of the trial site that receives the notice, must render an opinion about the appropriateness of the enforcement continuation for the institutional review board (IRB). When the IRB is

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Last update 4 October 2019

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