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    PREVENT PROTOCOL DEVIATIONS AND PROTOCOL VIOLATION 2016 - Protocol Deviations and Violations:The importance of knowing how to prevent them - By Compliance Global Inc

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    Website https://complianceglobal.us/product/700463/CharlesHPierce/protocol-%20deviations%20-and%20%E2%80%93v | Want to Edit it Edit Freely

    Category Education; E-Learning

    Deadline: July 19, 2016 | Date: July 19, 2016

    Venue/Country: online webinar, U.S.A

    Updated: 2016-06-27 21:17:06 (GMT+9)

    Call For Papers - CFP

    Overview:

    With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of “Not following the Protocol” has gained increasing importance. Protocol Deviations and Protocol Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study.

    Why Should You Attend:

    Those of us involved in Clinical Research must know that a well-written protocol is required for good clinical practice as part of research protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollmentis a key element in having a deviation free study conduct.Forewarned is forearmed.

    Areas Covered in this Webinar:

    How to know when the protocol in clinical research is not followed (PNF)?

    What is the difference between a clinical research protocol deviation and a violation?

    Importance of the clinical Protocol in the number of deviations occurring

    How to ensure that the protocol will be followed exactly?

    What is in the GCP Regulations about following the protocol?

    When may the Investigator make changes in the protocol?

    What are the causes of Protocol Deviations and Violations?

    How are Protocol Deviations managed?

    Examples of Protocol Violations and Deviations

    Learning Objectives:

    Demonstrate the primacy of the Study Protocol

    Determine when the Protocol is not followed (PNF) and what to do when this happens

    Describe the difference between a protocol deviation and a protocol violation

    Explain why a classification of PNF instances might be helpful

    Describe how and when to report Deviations / Violations

    Who Will Benefit:

    Principal Investigators and Sub Investigators

    Clinical Research Scientists (PKs, Biostatisticians)

    Research Managers

    Safety Nurses

    Clinical Research Associates (CRAs) and Coordinators (CRCs)

    Recruiting Staff, QA / QC Auditors and Staff

    Study Monitors

    Clinical Research Data Managers

    For more information, please visit : https://complianceglobal.us/product/700463/CharlesHPierce/protocol-%20deviations%20-and%20%E2%80%93violations-the-%20importance-of-knowing-how-to-%20prevent/1

    Email: supportatcomplianceglobal.us

    Toll Free: +1-844-746-4244

    Tel: +1-516-900-5515

    Level:

    Intermediate

    Speaker Profile:

    Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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