irb-reporting-protocol-deviations-adverse-events-ind-safety-reports

1. IRB reporting: Protocol deviations, adverse events, IND safety
reports
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.
Overview
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:
 Protocol deviations, violations, exceptions and waivers
 Adverse event reporting
 IND Safety reporting
 Unanticipated problem reporting
 Tools for determining if an adverse event is an unanticipated problem
 Reasons for over-reporting
 Identity practical solutions
 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.
Webinar Details
Date : January 11th
Wednesday 2016
Time : 01:00PM ET /
10:00AM PT
Duration: 60 Minutes
Speaker : Lynn Meyer
President ,IntegReview
IRB.
REGISTER

2. By revising internal policies that require reporting of events not required by regulation, staff time and money can be put
to better use. During inspections by FDA, OHRP, sponsors and CROs you should feel confident in your knowledge of
the regulations to support findings that are not based on regulations.
Upon completion of this webinar you should feel no hesitation asking the sponsor to change the protocol when it
requires reporting to the IRB of events that are not required by federal regulations.
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.
A tool for determining if an adverse event is an unanticipated problem will be provided and described. The
webinar will describe the three criteria required to be met for an adverse event to be considered an unanticipated
problem. Several examples of unanticipated problems will be discussed. Practical solutions for identifying change
will be presented as well as statistics that demonstrate the amount of time and money that could be saved by
eliminating over-reporting.
The webinar will provide recommendations for improved efficiency and reduction of burden on staff members
allowing them more time for other duties. The results of a recent online survey on expedited safety reporting to
IND investigators, conducted by Clinical Trials Transformation Initiative (CTTI) will be presented, which
demonstrates the reason for reporting as well as the estimated staff time involved in processing and reporting. The
survey will also reflect the cost involved with over-reporting.
Learning Objectives
• 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

3. Speakers Profile
Lynn Meyer
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.
As a woman-owned business, IntegReview IRB is certified by the Women’s Business Enterprise (WBE) and is an
accredited business by the Better Business Bureau.
Her career in medical research began in 1986 at one of the country's premier CROs in Austin, Texas, where she
advanced from various administrative positions to an 11-year term as manager of its affiliated Institutional Review
Board. During this time, she had the advantage of expanding her knowledge of managing all the nuances of a
growing company while also being mentored by knowledgably regulatory affairs personnel.
In an effort to advance her career, she transferred to the Quality Assurance Department. During her training
period, while reviewing approved informed consent documents that were missing basic elements of consent, she
realized just how much she missed the IRB world. Her passion for protecting human research subjects
encouraged her to pursue the creation of IntegReview IRB.
Lynn has been active in the Consortium of Independent Review Boards (CIRB) since its 1993 inception and
currently serves as the Chair. Additionally, she represents IntegReview as a Global Impact Partner with the
Society of Clinical Research Sites (SCRS). During the annual conference she a participant on panels for the
breakout sessions.
She has been an invited speaker at industry conferences presenting regulatory and human subject protection
topics and also conducts webinars on the same topics for various originations.
A high school graduate from a small Midwest town, she has gained working knowledge of the research industry
from highly educated individuals, to whom she credits her success.
In 2007, Lynn satisfactory completed all the stated requirements to earn her Certification of Clinical Research
Professionals (CCRP).
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