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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

Friday July 3, 2009

  • 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  • New FDA Draft Guidance document issued: Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting - Improving Human Subject Protection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

The Clinical Research Quality Assurance Expert's Expert Sourcesm
Clinical Research Audit Training

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

Institutional Review Boards Registration Requirements

By Phyllis B. Kent

 The Food and Drug Administration (FDA) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS).

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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