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The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

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This webinar will discuss the role of the ethics committee, the trial sponsor and investigator in providing an adequate Informed Consent (IC). It will discuss challenges and practical limitations in ensuring your informed consent is GCP compliant.

Speaker
Instructor: Stephen Schwartz
Product ID: 702538

Course "The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

The purpose of this course is to explore the divergent perspectives and practical limitations of the ethics committee, sponsor, and investigator as the basis for this continuing and troubling GCP non compliance observation. No one in the clinical research field intends to provide inadequate Informed Consent. We will discuss a case study that includes findings/observations. The GCP non-compliance challenges in this system of shared responsibility will be presented.

This course is not a regulatory review of the regulations or guidance on informed Consent. This course will ask questions about the roles of the clinical research entities who share the responsibility to implement adequate voluntary informed consent- the process. The divergent perspectives of the sponsor, investigator, and ethics committee lead each to sometimes very different determinations of compliance. There are, for many of these questions, not any obvious correct answers. Your comments and questions will hopefully enable each course participant to reach their own conclusions.

At the closure of this course- We will discuss, time permitting, a case where the sponsor and ethics committee did not want to know about investigator failure to provide adequate informed consent- what happened and the surprising outcome will be presented.

Areas Covered in this Webinar:

Who Will Benefit:

Instructor Profile:

Steve Schwartz, is the founder of Solaris Research Corporation. He has a background in basic virology research, progressing into 10 years clinical research program administration in the pharmaceutical industry. Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level. 10 years of CRO experience culminated in the formation of his full service CRO in 1989, under the initial name of Commonwealth Clinical Research Corporation- now Solaris Research Corp. Steve has also served as the investigator for several phase four clinical trials. He has served on an academic IRB. After a brief retirement he worked as Senior Manager, Global Clinical Operations/ GCP for Reckitt Benckiser Pharmaceuticals from March 2008 until July 2012. The objectives of successfully completing two clinical programs, building a global clinical research function, and developing a novel therapeutic biologic agent were completed in July 2012. Escaping from the corporate environment he is again in retirement he continues to speak and consult internationally to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, clinical monitoring, best practices.

Relevant to Clinical Quality Assurance, Steve and his associates have designed basic and advanced CQA courses for delivery to Health Canada and US Government agencies, to the pharmaceutical industry, and to academic institutions. Solaris Research provided clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Solaris Research published an electronic clinical trial conduct newsletter from 2000 to 2008.

Steve has a BS degree in microbiology/infectious disease with graduate courses in immunology/virology and pharmacology, and business management. Steve has made many presentations on clinical operations, clinical monitoring, study program management, and CQA.

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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 only 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."
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