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Clinical Trials Resource Group

Clinical Trials Resource Group

2010 IND/IDE Lecture Series Presentations



Agenda for the IND/IDE Seminar Series for Fall 2010


August 27, 2010 Overview of the investigator responsibilities under IND, and IND exemptions

  • Definitions of Drug, Device, Comb product
  • 21 CFR 312
  • Overview of Drug dev and IND process
  • CDER org chart and where to call ( )
  • Botanicals - special category
  • Cancer Center - Clinical Trials Support Unit (CTSU) Best Practices
    • Protocol Development
    • IND exemptions - CC consultative process
    • Submit Protocol, Informed Consent Document, and other study materials to UC Davis IRB
    • Conduct a protocol initiation meeting
    • Post study on

Handouts 08-27-10 

Presentation: IND Process and General Responsibilities under IND 


September 3, 2010 IND filing, timelines, paperwork and reports

  • UC Davis IND webpage
  •  IND filing deadlines
  • Pre-IND meeting, timelines, information package, minutes
  • IND cover letter with examples
  • IND table of contents
  • Completing Form 1571
  • Completing Form 1572
  • Binders and where to send
  • What happens after submission
  • Amendments
  • Annual reports - table of contents, when to send
  • Withdrawing of IND
  • Inactive status of IND

IND Filing, Timelines, Paperwork and Reports Presentation


September 10, 2010 Monitoring and Special Considerations for multi-center trials

  • Basic Principles
    • Investigator's Responsibilities
    • Sponsor's Responsibilities
    • Monitor's Responsibilities
  • Study Initiation Visit, Periodic Monitoring Visits, Study Termination/Closeout
  • Safety Reporting
  • Record Retention
  • Communicating with other sites
  • Other

Monitoring and Special Considerations for Multi-Center Trials


September 17, 2010 IDE filing and performing studies under IDE regulations

Standards List

IDE Regulation Overview 


September 24, 2010 GLP/GMP regulations and why it is important

  • Definitions: GLP, GTP, GMP
  • How GLP studies should be conducted
  • How GTP compares with GMP
  • GMP facilities and operations
  • What can be GMP manufactured at UC Davis
  • How an investigator at UC Davis can have a product GMP manufactured and quality controlled so an IND will have an appropriate clinical grade product
  • IND support of cellular and stem cell products for the investigator by the UC Davis GMP facility

Presentation: GLP GMP GTP 


October 1, 2010 FDA Audits - DVD