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. 

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 January 2018
GOOD CLINICAL PRACTICE  

E6 (R2): 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 

CPR Position on RQAP exam Review Courses 

 

Exam Contacts:

SQA Headquarters
154 Hansen Road, Suite 201
Charlottesville, VA 22911
Telephone: +1 434.297.4772
Facsimile: +1 434.977.1856
rqap@sqa.org
 

Council on Professional Registration:
Melissa A Meyer-Ely RQAP-GCP
GCP Exam Subcommittee Chair
Syneos Health, Inc.
Telephone: +1 513.652.0017
melissa.meyerely@syneoshealth.com

  

Testing Services Provider:

Professional Testing, Inc.
301 E. Pine Street, Suite 505
Orlando, FL 32801 USA
Telephone: +1 800.330.3776 (U.S. and Canada)
Telephone: +1 407.264.2993 (International)
Web: www.proftesting.com