Clinical Research Center2010 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 ( http://www.fda.gov/Drugs/default.htm )
- 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 clinicaltrials.gov
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
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
