Good Clinical Practice: A Question & Answer Reference Guide - May 2011 - (Page 743)

European Union Good Clinical Practice Directive EUROPEAN UNION GOOD CLINICAL PRACTICE DIRECTIVE COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use,1 and in particular Article 1(3), Article 13(1) and Article 15(5) thereof, Whereas: (1) Directive 2001/20/EC requires the adoption of principles of good clinical practice and detailed guidelines in line with those principles, minimum requirements for authorisation of the manufacture or importation of investigational medicinal products, and detailed guidelines on the documentation relating to clinical trials to verify their compliance with Directive 2001/20/EC. (2) The principles and guidelines for good clinical practice should be such as to ensure that the conduct of clinical trials on investigational medicinal products, as defined in Article 2(d) of Directive 2001/20/EC, is founded in the protection of human rights and the dignity of the human being. (3) Manufacturing requirements to be applied to investigational medicinal products are provided for by Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.2 Title IV of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use3 contains the provisions applied for the authorisation for the manufacture of medicinal products as part of the requirements needed for the application for a marketing authorisation. Article 3(3) of that Directive establishes that these requirements are not applicable for medicinal products intended for research and development trials. It is therefore necessary to lay down minimal requirements regarding applications for and management of authorisations to manufacture or import investigational medicinal products, as well as for the granting and the content of the authorisations, in order to guarantee the quality of the investigational medicinal product used in the clinical trial. (4) With regard to the protection of trial subjects and to ensure that unnecessary clinical trials will not be conducted, it is important to define principles and detailed guidelines of good clinical practice whilst allowing the results of the trials to be documented for use in a later phase. (5) To ensure that all experts and individuals involved in the design, initiation, conduct and recording of clinical trials apply the same standards of good clinical practice, principles and detailed guidelines of good clinical practice have to be defined. (6) Provisions for the functioning of the Ethics Committees should be established in each Member State on the basis of common detailed guidelines, in order to ensure the protection of the trial subject while at the same time allowing a harmonised application in the different Member States of the procedures to be used by Ethics Committees. (7) To secure the compliance of clinical trials with the provisions on good clinical practice, it is necessary that inspectors ensure the practical effectiveness of such provisions. It is essential therefore to provide detailed OJ L 121, 1.5.2001, p. 34. OJ L 262, 14.10.2003, p. 22. 3 OJ L 311, 28.11.2003, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34). 1 2 743

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2011

Good Clinical Practice: A Question & Answer Reference Guide - May 2011
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2011