This course provides an overview of the applicable regulations for
INVESTIGATOR-INITIATED TRIALS (IITs), including the role and
responsibilities of the individual INVESTIGATOR WHO ACTS AS AN
INVESTIGATOR AND A SPONSOR IN CONDUCTING THE STUDY. The seminar
includes a review of the reporting requirements and essential
documentation required for these TRIALS, and illustrates the risks
involved. Tips on how to avoid the common pitfalls are addressed,
including examples from FDA inspections and how to prepare for a
possible inspection.Learning Objectives:
1. Explain the applicable federal regulations for IITs, including
sponsor and investigator responsibilities
2. Recognize GCPs and the principles involved in quality research
3. State the steps involved in initiating an IIT, and review the
regulatory reporting requirement of investigators and sponsors,
including safety reporting and investigational product accountability
4. Examine protocol development and compliance
5. Examine informed consent development and the HIPAA authorization
6. Discuss required essential documentation and the need to remain
“audit-ready” throughout the study
7. Discuss the need for adequate monitoring and a monitoring plan
8. Cite ways to minimize risks associated with IITs
9. Provide examples of regulatory deficiencies as noted in FDA Warning
Letters
10. Discuss the principles of ethics and the quality control process,
including possible FDA inspections
INVESTIGATOR-INITIATED TRIALS AND THE ROLE AND RESPONSIBILITIES OF THE
INVESTIGATOR
DATE: Friday, March 29, 2019
TIME: 8:30 AM - 5:00 PM
LOCATION: 413 East 69th Street, 2nd floor, Room: BB 204 A/B/C
culture
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05/06/2020 Last update