RQAP-GCP Examination Study References

RQAP Program News • GLP Examination • GLP Study References • GCP Examination • GCP Study References • Re-registration • CPR Home

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