Key Skills for Ensuring Quality Control

Bibliography
Boniface, Duane. Homeland Security Digital Library (HSDL) (Limited collection). “Principles of
Risk-Based Decision Making.” https://www.hsdl.org/?view&did=471178 Accessed
25Jan2018

"CTTI Organization." Clinical Trials Transformation Initiative. Web. Accessed 25Jan2018.

http://www.ctticlinicaltrials.org/

"Efficacy Guidelines." The International Conference on Harmonisation of Technical

Requirements for Registration of Pharmaceuticals for Human Use (ICH). Web. Accessed
25Jan2018.. http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

"FDA CDRH Quality Management Program." FDA CDRH Quality Management Program. Web.
Accessed 25Jan2018.
http:/www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/%
20CDRHQualityManagementProgram/default.htm

Finnigan, Tammy, Duncan Hall, Chad Finch, Mike Emanuel, and Neil Watkins. "Position Paper:
Designing Risk Detection Indicators for Risk-Based Monitoring." Triumph Consultancy. Web.
Accessed 25Jan2018. www.tritrials.com

"ICH Quality Guidelines." ICH Web Site. Web. Accessed 25Jan2018.

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q
9_Guideline.pdf

ISO (International Organization for Standardization).Web. Accessed 25Jan2018.

http://www.iso.org/iso/home.html

ISO 9000 Quality Management System - Fundamentals and Vocabulary. ISO. 2005

Jones, Adam. "Adam Jones Coaching - Blogs and Articles." Adam Jones Coaching - Blogs and
Articles. Web. Accessed 25Jan2018.
http://www.adamjonescoaching.co.uk/page15.htm

National Institute of Standards and Technology (NIST). Special Publication 800-30. “Risk
Management Guide for Information Technology Systems.” Web. Accessed 25Jan2018.
http://csrc.nist.gov/publications/nistpubs/800-30/sp800-30.pdf

© Association of Clinical Research Professionals | acrpnet.org

"Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring." FDA Guidance.
Web. Accessed 25Jan2018.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance
s/UCM269919.pdf

"Pharmaceuticals and Medical Devices Agency, Japan." Pharmaceuticals and Medical Devices
Agency, Japan. Web. Accessed 25Jan2018. http://www.pmda.go.jp/english/index.html

Redfearn, Suz. "CTTI report recommends risk-based monitoring." CenterWatch. Web. Accessed
25Jan2018.
https://www.centerwatch.com/news-online/2011/08/15/ctti-report-recommends-risk-based-
monitoring/

"Reflection paper on risk based quality management in clinical trials." European Medicines
Agency. Web. Accessed 25Jan2018.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC5
00110059.pdf

The AVOCA Group. Accessed 25Jan2018.

http://theavocagroup.com

Transcelerate Biopharma INC. Accessed 25Jan2018 .

http://www.transceleratebiopharmainc.com

World Health Organization. Accessed 25Jan2018.

http://www.who.int/patientsafety/education/curriculum/course5a_handout.pdf

© Association of Clinical Research Professionals | acrpnet.org