Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 561)

Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, and India Given the global nature of the clinical research enterprise today, a resource guide on good clinical practice would be remiss if it failed to address the GCP and clinical research standards within several of the countries and regions that are becoming increasingly important centers for clinical trials. Authored by or with the assistance of local experts in each country/region, the chapter below highlights and explores the GCP and clinical research standards applicable in several such countries/regions—Latin America, China, Russia, and India. GCP and Clinical Research Standards in Latin America by Anne Blanchard, CRA, CEO- Clinical Operations Manager Blanchard & Associates, Buenos Aires, Argentina 1 Q. What are the key laws, regulations, and guidelines that establish the legal and regulatory framework for clinical trials in Latin America? A. Several countries in Latin America, such as Argentina, Chile, Brazil, Mexico, Peru, Costa Rica, and Colombia, have been conducting clinical trials for over a decade. With regard to clinical trials, there are no unique published rules and regulations applicable to the Latin American region as a whole, which implies 20 countries and two major languages spoken: Spanish and Portuguese. In the last five years we have seen revisions in the regulations for Argentina, Mexico, Brazil, Chile, Peru and Colombia. Brazil (*819), Mexico (*391) and Argentina (*297) are the countries that conduct more clinical trials in Latin America. Right behind are Chile (*176), Colombia (*163) and Peru (*145). In these most active countries, the clinical trials regulations are based on ICH GCP and other relevant guidelines, such as the WHO guidelines (see Q1.3). While Latin America is not among the ICH regions, many Latin American countries are involved in global clinical trials designed to support registration in ICH countries. They follow the applicable guidelines and regulations in accordance with where the studies are registered or the data intended for submission (i.e., ICH Guidelines, FDA regulations, EU Directive) and the universal ethical principles established in the Declaration of Helsinki. In fact, the First Regulations specifically applying to Clinical Research in Argentina (Regulation N 4854) and Brazil (Regulation N196) which were both issued in 1996, are both based on the ICH GCP Guidelines. Due to the significant increase in clinical trials in the region and in an effort to harmonize the GCPs in the in the Americas, the Pan American Network for Drug Regulatory Harmonization (PANDRH) published a document entitled, “Good Clinical Practice: Document of the Americas” (2005). This guideline resulted from the work of a GCP expert group (2000 to 2005) that involved the FDA and regulators from Latin America. Industry representatives from Latin America (FIFARMA and ALIFAR) provided comments, which were then incorporated into the guideline. The principal guidelines considered in the development of the “Document of the Americas” One important additional incorporation by the Document of the Americas which embraces ICH GCPs is listed as Chapter 7 GCP Compliance Monitoring Programs by Regulatory Authorities, providing guidance on how Agencies should develop their own regulations on inspections. Argentina is within Latin America the country with the longest tradition for local agency inspections. ANMAT developed its Inspection Guidelines in 2005 and has now reviewed them incorporating the revised text as section of the 6677/2010 Provision. Brazil published its guideline in 2009 and is now actively conducting inspections. Chile is starting and Peru had already issued a guideline on inspections in 2007. Another characteristic of the Document of Americas is that it has issued separate individual chapter to provide guidance on the Informed Consent (as opposed to ICH GCP that included this as part of the investigator in section 4.8 561

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
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, Ukraine, 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 2012