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                Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

                        BIMO Inspection Metrics
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          Clinical Trials Guidance Documents


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          Clinical Trials and Human Subject Protection
          ICH Guidance DocumentsClinical Trials and Human Subject Protection ICH Guidance Documents
  
  	
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    Print**ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB)**

This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects. The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review.

**ICH E3 Questions and Answers (PDF - 141KB)**

**ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB)**

This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors.

**ICH E5 Questions and Answers (PDF - 48KB)**

**ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB)**

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

**ICH E7: Studies in Support of Special Populations: Geriatrics Questions and Answers**

This ICH guidance provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly. This question and answer (Q&A) document is intended to clarify key issues.

**ICH E10: Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB)**

This International Conference on Harmonization (ICH) guidance addresses the choice of control group in clinical trials, discussing five principal types of controls, two important purposes of clinical trials, and the issue of whether a trial could have detected a difference between treatments when there was a difference (assay sensitivity).

**ICH Q9: Quality Risk Management (PDF - 113KB)**

The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements

**VICH GL9: Good Clinical Practice (PDF - 64KB)**

The objective of this document is to provide guidance on the design and conduct of all clinical studies of veterinary products in the target species. It is directed at all individuals and organizations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species and is intended to ensure that such studies are conducted and documented in accordance with the principles of Good Clinical Practice (GCP). Good Clinical Practice is intended to be an international scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting clinical studies evaluating veterinary products. This guidance has been developed under the principles of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and will provide a unified standard for the European Union (EU), Japan and the United States of America (USA) to facilitate the mutual acceptance of clinical data by the relevant regulatory authorities. This guidance was developed with consideration of the current practices in the EU, Japan and the USA together with those of Australia and New Zealand.

                                                                                  Content current as of:
      03/29/2018Clinical Trials and Human Subject Protection

          
                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 
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