Key Take Away:
This webinar will cite specific regulations regarding federal reporting requirements and discuss how some of these regulations have been misinterpreted resulting in increased burden on sites as well as IRBs and give recommendations on how you can initiate change.
Over FDA regulation reporting of adverse events and IND safety reports results in a loss of valuable resources, which include staff time and money.
Standard Operating Procedures created by sponsors, CRO’s, IRBs and sites typically go above and beyond what is required by federal regulation. Thus, creating misconstruction in the research industry about what is required by federal regulation.
Specific issues to be presented include:
o Protocol deviations, violations, exceptions and waivers
o Adverse event reporting
o IND Safety reporting
o Unanticipated problem reporting
o Tools for determining if an adverse event is an unanticipated problem
o Reasons for over-reporting
o Identity practical solutions
o Cost of over-reporting
Results of a CTTI survey of expedited safety reporting to IND investigators will be presented.
Why Should You Attend:
How often have you heard, “This is the way we have always done it.”? We often create Standard Operating Procedures that go above and beyond what is required by federal regulations. Concern of not doing enough or when we feel uncertain, we may feel pressure to do more than is expected.
By attending this webinar, you will achieve an understandingof the difference between regulations and what has become the standard of practice in our industry over the years. You should gain a clear understanding of the regulations that result in the enhancement of your knowledge putting to rest fears of non-compliance. Your working knowledge of the regulations will result in increased confidence performing research related tasks as well as making you more confident in knowing what to report to the IRB.
Areas Covered In This Webinar:
Areas covered in this session will consist of a review of federal reporting requirements as described in the Code of Federal Regulations for FDA sponsored research as well as OHRP funded research.
Additionally, ICH Guidelines, adopted by FDA will be discussed. Specifically, reviewed will be regulations associated with adverse events, IND safety reporting in clinical trials, unanticipated problems, and protocol deviations/violations/exceptions.
We will review the federal regulations pertaining to sponsors, principal investigators and IRBs. Federal regulations to be reviewed include, Title 21 CFR Part 56, Institutional Review Boards, Title 21 CFR Part 312, Investigational New Drug Application, and International Conference on Harmonisation, Efficacy Guidelines, E6 Good Clinical Practices.
Attendees will learn to whom the Principal Investigator is required to report serious adverse events that are not determined to be an unanticipated problem. Five reasons for over-reporting will be examined. Guidance documents related to this topic provided by federal agencies as well as ICH will also be reviewed.
• Possess ability to differentiate federal regulations versus industry standard practice
• Acquire knowledge regarding reporting requirements
• Ability to determine when an adverse event is an unanticipated problem
• Discover process improvements
Who Will Benefit:
• Principal Investigators
• Research Nurses/ Staff
• Pharmaceutical Sponsors
• Project Managers
• Project Assistants
• Clinical Research Associates
• IRB Staff and Committee Members
Lynn Meyer founded IntegReview IRB, an Independent Ethical Review Board, and a woman-owned business, in 1999. As its current president and managing partner, she provides guidance and support to the firm as well as business development and client relations. Under her leadership, the IRB has grown to include six boards that now serve clients in the United States, Canada and Latin America as well as a wide breadth of high-profile industry research sites and sponsors.
In 2007, through her guidance and direction, IntegReview achieved full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which continues to be sustained.
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