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. PLEASE NOTE: In August 2012, the RQAP-GCP Examination Committee revised this list to simplify it. The references listed below represent the most important and frequently addressed references on the exam.
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/index-eng.php
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/privacy/
US Office for Human Research Protections
http://www.hhs.gov/ohrp/
REFERENCES:
US CODE OF FEDERAL REGULATIONS
21 CFR Part 11 – Electronic Records; Electronic Signatures
21 CFR Part 312 – Investigational New Drug Application
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 812 – Investigational Device Exemptions
45 CFR Part 46 – Protection of Human Subjects (Common Rule)
EUROPEAN MEDICINES AGENCY
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
Commission Directive 2005/28/EC of 8 April 2005
US FOOD AND DRUG ADMINISTRATION
Compliance Program Guides
Final Guidance Documents
HEALTH CANADA
Guidance for Records Related to Clinical Trials – GUI 0043; GUI 0036; GUI 0068; Inspection Strategy for Clinical Trials
Regulations Amending the Food and Drug Regulations (Schedule No. 1024 – Clinical Trials, 20 JUN 2001)
INTERNATIONAL CONFERENCE ON HARMONIZATION
As of November 2005
GOOD CLINICAL PRACTICE
E6 (R1): Good Clinical Practice: Consolidated Guidelines
INTERNATIONAL STANDARDS ORGANIZATION (ISO)
14155 - GCP for Medical Devices
OTHER EU AND UK DOCUMENTS
The Rules Governing Medicinal Products in the European Union: Volume 10 Clinical Trials
UK Statutory Instrument (SI) 2004/1031 - The Medicines for Human Use (Clinical Trials) Regulations
UK Statutory Instrument (SI) 2006/1928 - The Medicines for Human Use (Clinical Trials) Amendment Regulations