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The following is a listing of suggested Quality Assurance references. This list is not all-inclusive and candidates should not limit their study to only those references listed below. Candidates are also encouraged to study all historic and current preambles in addition to the current regulations, where applicable.
WEBSITES:
Each of the regulations and guidance documents listed in the references below can be found through the following websites. It may be necessary to search the title of the referenced document at the website.
International Conference on Harmonization
http://www.ich.org
Health Canada – Drugs & Health Products
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/legislation/acts-lois/index_e.html
European Medicines Agency
http://www.emea.europa.eu
US Food and Drug Administration
http://www.fda.gov
US Office for Civil Rights – HIPAA
http://www.hhs.gov/ocr/hipaa/
US Office for Human Research Protections
http://www.hhs.gov/ohrp/
REFERENCES
INTERNATIONAL CONFERENCE ON HARMONIZATION:
As of November 2005
CLINICAL SAFETY
E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E2B (R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
E2C (R1): Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs (in E2C (R1)
E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
E2E: Pharmacovigilance Planning
CLINICAL STUDY REPORTS
E3: Structure and Content of Clinical Study Reports
DOSE-RESPONSE STUDIES
E4: Dose-Response Information to Support Drug Registration
ETHNIC FACTORS
E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data
GOOD CLINICAL PRACTICE
E6 (R1): Good Clinical Practice: Consolidated Guidelines
Clinical Trials
E8: General Consideration of Clinical Trials
E9: Statistical Principles for Clinical Trials
E10: Choice of Control Group and Related Issues in Clinical Trials
CLINICAL EVALUATION
E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
HEALTH CANADA
The Food and Drug Regulations (C.R.C., c. 870) - Part C, and Part J
Regulations Amending the Food and Drug Regulations (Schedule No. 1024 - Clinical Trials, 20 JUN 2001)
Medical Devices Regulations (SOR/98-282) Part 3
Guidance for Records Related to Clinical Trials – Guide 0068
Health Canada Compliance and Enforcement Policy (POL-0001), Version 2
Inspection Strategy for Post-Market Surveillance (POL-0041)
EUROPEAN MEDICINES AGENCY
Commission Directive 2005/28/EC of 8 April 2005
Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004
Commission Directive 2003/63/EC of 25 Jun 2003 Annex 1 “Analytical, Pharmacotoxicological and Clinical Standards and Protocols in Respect of the Testing of Medicinal Products”
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
US CODE OF FEDERAL REGULATIONS: TITLE 21 FOOD AND DRUGS
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
21 CFR Part 314 - Applications for FDA Approval to Market a New Drug
21 CFR Part 320 - Bioavailability and Bioequivalence Requirements
21 CFR Part 601 - Biologics Licensing
21 CFR Part 812 - Investigational Device Exemptions
21 CFR Part 814 - Premarket Approval of Medical Devices
PREAMBLES TO FDA GCP REGULATIONS: Preambles to the FDA regulations can be found through the FDA website
GUIDANCE DOCUMENTS AND INFORMATION SHEETS ON GOOD CLINICAL PRACTICE IN FDA-REGULATED CLINICAL TRIALS
FDA Information Sheets for Institutional Review Boards, Clinical Investigators and Sponsors
The Belmont Report 18 Apr 1979
The Declaration of Helsinki; World Medical Association; 1983 and 1989 versions
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection
Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
Guidance for Industry: Acceptance of Foreign Clinical Studies
Guidance for Industry: Available Therapy
Guidance for Industry: Computerized Systems Used in Clinical Trials
Guidance for Industry: Development and Use of Risk Minimization Action Plans
Guidance for Industry Exploratory IND Studies
Guidance for Industry: Financial Disclosure by Clinical Investigators
Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies
Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
Guidance for Industry: Guideline for the Monitoring of Clinical Investigators
Guidance for Industry: Guideline for the Study and Evaluation of
Gender Differences in the Clinical Evaluation of Drugs
Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples;
Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations under FDA Regulations
Guidance for Industry on Part 11: Electronic Records; Electronic Signatures – Scope and Application
Guidance for Industry and FDA Staff: General Principles of Software Validation
Guidance for Industry: Pharmacogenomic Data Submissions
Guidance for Industry: Premarketing Risk Assessment
Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct
Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trial
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
BIORESEARCH MONITORING PROGRAM
(Compliance Program Guidance Manuals – CPGM)
CPGM 7348.811 Clinical Investigators
CPGM 7348.810 Sponsors, Monitors, and Contract Research Organizations
CPGM 7348.001 In-Vivo Bioequivalence Compliance Program
CPGM 7348.809 Institutional Review Boards
OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP)
45 CFR Part 46 Protection of Human Subjects (Common Rule)
Office of Human Research Protections