IRB Reporting: Protocol Deviations, Adverse Events, IND Safety Reports Webinar Details Date : October 20th Thursday 2016 Time : 01:00PM ET / 10:00AM PT REGISTER Duration: 60 Minutes Speaker : Lynn Meyer., President ,IntegReview IRB 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.

Areas Covered In This Webinar 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 Speakers Profile Lynn Meyer

accredited business by the Better Business Bureau. 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). AtoZ Compliance, 2754 80th Avenue, New Hyde Park, NY 11040 Email: support@atozcompliance.com Toll Free: +1- 844-414-1400 Tel: +1-516-900-5509 Fax: +1-516-300-1584 Our support team is available from 9:00AM - 5:00PM Eastern; Monday to Friday