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Resources

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General Guidances

Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects
EMA FDA GCP FAQs
US Food and Drug Administration - European Medicines Agency - Good Clinical Practice Initiative Frequently Asked Questions and Answers
EMA FDA GCP Initiative
European Medicines Agency - Food and Drug Administration - Good Clinical Practices Initiatives
ICH Definitions and Standards for Expedited Reporting
International Conference on Harmonization - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH GCP
International Conference on Harmonization - Guideline for Good Clinical Practice
ICH Guideline for Structure and Content of Clinical Study Reports
International Conference on Harmonization - Structure and Content of Clinical Study Reports
Tri-Council Policy
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

Guidances by Jurisdiction

Canada

HC Inspection Strategy_Clinical Trials
Inspection Strategy for Clinical Trials
HC_Clinical Trial Inspection Observations
Classification of Observations made in the conduct of inspections of clinical trials.
HC_GMP Guidelines for Clinical Trials
Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines - Drugs used in Clinical Trials
HC_Records Retention for Clinical Trials (Regulatory Binder)
Guidance for Records Related to Clinical Trials
ICH_GCP (Health Canada) Guideline
Good Clinical Practice: Consolidated Guideline

European Union

EMA GCP Inspection Pt 1
Procedure for Coordinating GCP Inspections Requested by the EMEA - Part 1
EMA GCP Inspection Pt 2
Procedure for Coordinating GCP Inspections Requested by the EMEA - Part 2
EMA GCP Inspection Pt 3
Procedure for Coordinating GCP Inspections Requested by the EMEA - Part 3
EU dir_2001_20_en
Directive 2001/20/EC
EU dir_2005_28_en
Commission Directive 2005/28/EC
EU GCP Inspect Annual Rpt 2011
Annual Report of the Good Clinical Practice Inspectors Working Group 2011

United States of America

FDA CPGM Investigators
Clinical Investigators and Sponsor Investigators: Bioresearch Monitoring Guidance
FDA CPGM REBs
Institutional Review Boards Guidance
FDA CPGM Sponsors CROs Monitors
Sponsors, Contract Research Organizations and Monitors Guidance
FDA Foreign Clinical Studies
FDA Acceptance of Foreign Clinical Studies not Conducted Under an IND
FDA GCP Monitors
Guidance for Industry Oversight of Clinical Investigations - A Risk-based Approach to Monitoring
FDA ICF FAQs
Questions and Answers on Informed Consent Elements
FDA Investigator Responsibilities
Guidance for Industry - Protecting the Rights, Safety, and Welfare of Study Subjects

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