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A Guide for Investigators and Sites Management Report

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WCG CenterWatch

WCG CenterWatch


FALLS CHURCH, Va. (PRWEB)

Assessing Adverse Event Causality:

A Guide for Investigators and Sites

A CenterWatch Management Report

https://www.centerwatch.com/products/554

Confident in determining adverse event causality? While this is one of the most important responsibilities, it is also the most burdensome: is this event due to the investigational product (IP)? Or something else entirely…?

Assessing Adverse Event Causality: A Guide for Investigators and Sites answers all the questions and shows readers how to proceed.

It walks readers through a nine-step process for evaluating adverse events (based on the Bradford Hill Criteria for Causality model), explains what information to collect, what questions to ask and how to analyze the answers. Come to a yes-no, related-nonrelated conclusion that can be reported to a IRB and sponsor.

Assessing Adverse Event Causality also explains what information the FDA and other regulators expect in those reports. Understand the terms and concepts that should — and those that should not — be used. And one will see all of the concepts illustrated clearly through case studies.

Management report takeaways:

  • How to apply the nine principles of causality: strength of association, consistency, temporality, specificity, biological gradient, plausibility, coherence, experiment and analogy

  • What sources of information can help in analyzing the event (e.g., preclinical information, medical literature, Investigator’s Brochure)

  • Which aspects of a patient’s history should be examined

  • How to apply the dechallenge/rechallenge test

  • Whether the terms “probable” and “possible” should be used

Gain patient safety and trial success and make critical decisions about adverse events with ease. Get there with Assessing Adverse Event Causality: A Guide for Investigators and Sites.

Management Report Details:

Assessing Adverse Event Causality:

A Guide for Investigators and Sites

A CenterWatch Management Report

h ttps://http://www.centerwatch.com/products/554

Tuition:

$397

Easy Ways to Register:

Online:https://www.centerwatch.com/products/554

By phone: 888.838.5578 or 703.538.7600

About CenterWatch:

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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