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

• Clinical Research Fraud:
  A Victimless Crime?
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• 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
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• OIG Releases Report of FDA's Oversight of Clinical Trials
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	The Clinical Research Quality Assurance Expert's Expert Sourcesm
	Resources
	Foreign Clinical Studies Not Conducted Under an IND Protecting Rights, Safety, & Welfare of Subjects- Investigator Responsibility Guidance for Industry Computerized Systems Used in Clinical Investigations 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 British Association of Research Quality Assurance Data Protection in EU EMEA Europa - The European Union Online Guidance for exchange of GCP Inspection Reports according to Directive 200120EC art 15.2 Guidance for the communication on GCP inspections and findings Guidance for the conduct of GCP inspections Annex I to Guidance for the conduct of GCP inspections - investigator site Annex II to Guidance for the conduct of GCP inspection - clinical laboratories Annex III to Guidance for the conduct of GCP inspections - computer systems Annex IV to Guidance for the conduct of GCP inspections - Sponsor and CRO Guidance for the preparation of GCP inspections Guidance for the preparation of Good Clinical Practice inspection reports Complete EU Recommendation on Inspections Full set in zip format Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice (July 2006) Europe & International GCP Organizations EMEA INS-GCP-1 Procedure for coordinating GCP inspections EMEA INS-GCP-2 Procedure for preparing GCP inspections EMEA INS-GCP-3 Procedure for conducting GCP inspections EMEA INS-GCP-3 Annex I to Procedure for conducting GCP inspections - Investigator Site EMEA INS-GCP-3 Annex II to Procedure for conducting GCP inspection - Clinical Laboratories EMEA INS-GCP-3 Annex III to Procedure for conducting GCP inspection - Computerised Systems EMEA INS-GCP-3 Annex IV to Procedure for conducting GCP inspections - Sponsor and CRO EMEA INS-GCP-3 Annex V to Procedure for conducting GCP inspections - Phase I Units EMEA INS-GCP-3 Annex VI to Procedure for conducting GCP inspections - File structure and archiving EMEA INS-GCP-4 Procedure for reporting of GCP inspections EMEA Principal Documents taken into account for the preparation of procedures for the GCP inspections

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