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Deviations: What are they? Do you need to report?

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This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations.

Instructor: Sarah Fowler Dixon
Product ID: 702394

Why Should You Attend:

As the human subjects regulatory framework continues to grow and be further defined, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) prior to implementation by the study team. Alternatively, as studies become more complex and complicated the study team often has to make immediate decisions which may not allow time for a regulatory consult.

In this session, we will discuss what the current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research. This presentation is designed to define protocol deviations and review the requirements for reporting such events to regulatory authorities.

Learning Objective:

Those who attend this session should be able to identify a deviation and be able make an initial determination as to whether the deviation may be reportable to the Institutional Review Board (IRB).

Areas Covered in the Seminar:

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

Instructor Profile:

Dr. Sarah Fowler-Dixon,PhD, CIP has presented on various human subjects topics since 2001 at local, regional, and national conferences. She developed a comprehensive education program for human subject research which has served as a model for other institutions. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. Dr. Fowler-Dixon has served on various committees to improve research, procedures, community outreach, and retention.

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Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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COSO Framework for Internal Controls, Risk Assessment and Financial Statement Audit - 80225SEM

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Training Options Training Duration = 60 Min
$229.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$299.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days