Clinical Human Xenotransplantation

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Clinical Human Xenotransplantation

Laboratory Registration Instructions

Who should fill out this application? Investigators planning to do clinical studies involving the transfer of animal tissues into human subjects. Other forms are needed to register laboratory and human gene transfer studies. Download the form you want to use and save it to your computer.

Where do you send the filled in registration form? Your BioSafety officer can be found on the registration page.

What has to be sent to the BSO? A signed registration form, the investigator's brochure, the clinical protocol and the informed consent statement for this study.

Why is registration needed? Several reasons. Most importantly the University and affiliated hospitals wish to keep track of all human xenotransplantation studies. By centralizing this activity a consistent set of safety standards can be applied though out the university. In addition local IRBs often require Biosafety Committee approval before these studies can begin. Finally the FDA insists on Biosafety Committee approval.

Why is this form needed? There are lots of ways you can explain your project to COMS. However, when you use our forms it is easier for the COMS staff to find the information they need and your application is approved quickly.

  • Electronic filing
  • Word




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