RQAP-GCP Examination Study References
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.
This list has been updated as of February 2026. The references listed below represent the most important and frequently addressed references on the exam.
WEBSITES
International Conference on Harmonization
http://www.ich.org
Health Canada – Drugs & Health Products
https://www.canada.ca/en/health-canada/services/drugs-health-products/legislation-guidelines.html
European Medicines Agency
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20221205
US Food and Drug Administration
http://www.fda.gov
US Office for Civil Rights – HIPAA
https://www.hhs.gov/hipaa/for-professionals/index.html
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
Clinical Trials Registry Reg EU536/2014
Commission Directive 2005/28/EC
US FOOD AND DRUG ADMINISTRATION
Compliance Program Guides
Final Guidance Documents
HEALTH CANADA
Regulations amending the food and drug regulations (1024 -clinical trials)
"Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) - https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100/document.html
Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043) - https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/risk-classification-observations-inspections-clinical-trials-guide-0043.html
POL-0030: Compliance and enforcement approach and inspection strategy for clinical trials of drugs involving human subjects -https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/inspection-strategy-clinical-trials.html
INTERNATIONAL CONFERENCE ON HARMONIZATION
As of January 2018
GOOD CLINICAL PRACTICE
E6 (R3): Good Clinical Practice: Consolidated Guidelines
INTERNATIONAL STANDARDS ORGANIZATION (ISO)
ISO 14155:2020
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
REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) - https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng
European Medical Device Regulation 2017/745 (MDR) - https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20260101