Section outline

  • Discussion Seminar: Late phase clinical trials
    Good Clinical Practice; protocol design and writing; case report forms; investigator brochure; regulatory filings; budget; staff training; data management; safety reporting; site closeout; data analysis; report writing; record retention; regulatory requirements for approval; NDA/BLA and pre-NDA meeting.

    Faculty: Menghis Bairu and David Feigal

    Location:     Mission Hall 1106

    • Session Slides:

    • MB4 25UCSF Lecture 6(FINAL) File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Assignment:

      Go to http://www.ich.org/products/guidelines.html and download two of the documents, one of which should be E6, and another of your choice. You should read them, and discuss how the guidelines might 1) protect patient safety and 2) protect data integrity. Homework assignment due: May 6th, 2015.

    • Assignment Due Date: Case Study Assignment, Part I: Due May 6th: Email assignment to Dr. Chin and cc: Marlene Grenon by Monday, 05/6/15.

      May 1: Bring a copy of your current draft case study.

      Be prepared to present your case study in a small group.