Clinical Quality Assurance Training Web Site Design New Jersey Clinical Research Audit Training
Quality assurance of medical research is essential in the prevention of scientific misconduct and fraud that is in the forefront of the news today. When uncovered by FDA inspection or media research the effect on the research facility can be devastating. The Quality Research Training Institute trains clinical professionals in GCP compliance and monitoring
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LATEST NEWS

Monday February 8, 2010

  • EMEA-FDA GCP Initiative
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  • FDA IRB Registration Rule
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  • Study data may be fake.
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  • Biosearch Moniotring Information System (BMIS) File.
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  • New Release -International Compilation of Human Research Protections 2009 Edition
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  • New FDA Draft Guidance document issued: Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting - Improving Human Subject Protection
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  • FDA Revises Clinical Investigator Compliance Program CP 7348.811
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  • FDA Bars Doctors from Drug Trials.
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  • OHRP Spanish Pamphlet Now Available
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GCP FDA IRB Training

GCP FDA IRB Training

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Clinical Research Audit Training

Clinical Research Audit Training | Clinical Quality Assurance Training | GCP FDA IRB Training

Sponsoring the Training at Investigational Sites

by Rochelle L. Goodson

 Is it possible for you to ensure that clinical staff at your Investigational Sites are GCP-trained?

Clinical Management’s mantra for 2009 is "Doing more with less!"

Clinical Research Audit Training | Clinical Quality Assurance Training | GCP FDA IRB Training

Are Your Investigators Keeping Records for 20 Years?

By Phyllis B. Kent

 An FDA 2009 warning letter (01/14/09) cites deviations in a consent that was given over 20 years ago, October 6, 1988! The warning letter also cites missing informed consents and failure to maintain records for the required time.
Clinical Research Audit Training | Clinical Quality Assurance Training GCP FDA IRB Training

Clinical Research Audit Training Clinical Quality Assurance Training GCP FDA IRB Training

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