• EMEA-FDA GCP Initiative
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• FDA IRB Registration Rule
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• Study data may be fake.
  Read More

• Biosearch Moniotring Information System (BMIS) File.
  Read More

• New FDA Policy Strengthening the Regulation of Clinical Trials and Bioresearch Monitoring.
  Read More

• Clinical Study Coordinator for Pediatric Drug Sentenced for Fraud.
  Read More

• Allegations of Fake Research Hit New High.
  Read More

• Dangerous Practices:
  Critics see flaws in Drug-Safety Monitoring.
  Read More

• Clinical Research Fraud:
  A Victimless Crime?
  Read More

• Neuroscientist censured for misconduct.
  Read More

• Death Points to Risks in Research.
  Read More

• 'Scientific fraud' hampered spread of cancer technique
  Read More

• Psychiatrist indicted for fraud in Paxil trials
  Read More

• FDA Hit for Poor Clinical Trial Oversight
  Read More

• OIG Releases Report of FDA's Oversight of Clinical Trials
  Read More

	The Clinical Research Quality Assurance Expert's Expert Sourcesm
	USA Resources
	Guidance on Exculpatory Language in Informed Consent Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring FDA Guidance on FDA1572 FDA/ORA Bioresearch Monitoring Information Page Overview of Device Regulation Investigational Device Exemption Part 812 regs Institutional Review Boards; Registration Requirements. Biosearch Monitoring Information System (BMIS) File. Foreign Clinical Studies Not Conducted Under an IND International Compilation of Human Research Protections 2011 Edition Protecting Rights, Safety, & Welfare of Subjects- Investigator Responsibility FDA Revised Clinical Investigator Compliance Program CP 7348.811 Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting - Improving Human Subject Protection Guidance for Industry Computerized Systems Used in Clinical Investigations 21 CFR Part 50 Informed Consent Elements Proposed Amendment Guidance for IRBs,Clinical Investigators,and SponsorsIRB Continuing Review after Clinical Investigation Approval FDA Sponsor, Contract Research Organizations and Monitors Compliance Program CP7348.810 21 CFR Part 11 Title 45 CFR Part 46 Protection Of Human Subjects Office of GCP Clinical Trials Transformation Initiative (CTTI) Guidances and Information Sheets, FDA-GCP FDA Office of Regulatory Affairs Clinical Investigator Inspection List Financial Disclosure by Clinical Investigators NIDPOE Letters MedWatch Office for Human Research Protections (OHRP) ORI - Office of Research Integrity Office for Civil Rights - Privacy of Health Records Public Health Service List of Investigators Subject to Administrative Action Office for Human Research Protections (OHRP) Frequently Asked Questions and Answers on Informed Consent OHRP Spanish Pamphlet Now Available

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