Endpoint Adjudication by the Clinical Endpoints Committee (CEC) Webinar



11:00am - 12:00pm

Wednesday, September 12, 2018 | 11:00 AM PST / 2:00 PM EST
30 min talk followed by a 30 min Q+A (60 minutes)

This topic will introduce the concept of using a clinical endpoint committee, including familiarization with regulatory guidance, decision factors leading to its use, the methods by which they can be done, and the common practices and pitfalls in event processing.

* Describe the regulatory guidance pertaining to the use of CEC
* Describe the influencing factors leading to the decision to use or not use a CEC for a given clinical trial
* Describe the methods by which adjudicable events can be identified from the site-reported data
* Describe the methods by which adjudications can be accomplished
* Define the common sources and tools needed for proper adjudication
* Describe the common pitfalls in adjudication processing

Kyoko Hattori - VP, Scientific and Medical Affairs | Criterion Edge
Kyoko brings a wealth of expertise to the area of clinical safety. With more than 30 years of clinical research experience, she has done it all—clinical research nursing in academic and outpatient settings. She also worked at two major medical device manufacturers and most recently, at an international CRO. Kyoko has managed Safety from clinical trial to post-marketing in the US, EMEA, and Asia Pac geographies. Her most recent role was Director of Safety and Pharmacovigilance. Kyoko is fluent in Japanese and has managed entire Japanese programs including PMDA reporting.

Senior professionals working with adverse events reporting:
Clinical Scientist
Clinical Safety Specialist
Clinical Trial Project Managers
Clinical Data Managers
Clinical Research Associates (CRAs)
Medical Monitors
Drug Safety Specialist
Pharmacovigilance Professionals

We also gave another webinar previously: "Intro to Adverse Events Review". To watch the recording of it, click here:

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Contact: Jessica Sinha
Contact Phone: 805.202.5520 ext. 706
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