best gpc

Taken from the NEW Good Clinical Practice: A Question & Answer Guide 2015. 

Order Your Hard Copy Here!  Order Your Electronic Version Here! 

Question: How does a site/sponsor determine whether a laboratory—for example, a microbiological sampling laboratory or one that will only be used occasionally during the study—should be listed in Section #4 of the Form FDA 1572-Statement of Investigator, which calls for the “name and address of any clinical laboratory facilities to be used in the study”? 

Get the Answer! 

GPC Question of the Week
Clinical Project Management: Intermediate
August 18-19, 2015
Philadelphia, PA
Monitoring Clinical Drug Studies: Beginner
August 18-20, 2015
Philadelphia, PA



Barnett International Announces New SOP Development and Optimization Courses
February 21, 2012
Barnett International Announces New Fall-Winter Courses 2012
February 20, 2012
Barnett Educational Services Announces Buy One, Get One Free DVD Holiday Sale!
December 15, 2011
Hamrell Appointed Editor of Barnett International’s Good Clinical Practice: A Question & Answer Guide
November 16, 2011
Barnett International Announces New Fall-Winter Courses
September 29, 2011
Barnett Educational Services Announces Buy One, Get One Free DVD Sale!
June 6, 2011

Read More

Latest Blog Post

What's the Strategy Behind Strategic Partnerships?

Have you noticed a lot of "buzz" around the topic of strategic partnerships and alliances over the past few years? Have you wondered, like I have, exactly what do these terms mean? For an overview and some thoughts on what it all means to clinical research professionals, keep reading. According to the website diction

Read More

GPC Question of the Week


  • BWS 30-Hour CPM Certificate Program
  • GCP Q&A 2014
  • Stat Book 2014/2015

Superior clinical research training courses and training consulting services

Live Seminar 


Barnett Educational Services conducts more than 125 two- and three-day, instructor-led, interactive seminars throughout the United States.  Conducted by industry experts, our seminars cover the process of pharmaceutical, device, and biotechnology product development.

Web Seminar   

A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!

DVD Icon 


Were you unable to attend an Interactive Web Seminar? These DVD archives will allow you to watch recordings of previous Interactive Web Seminars any time you want.  Pricing is available for single users and site licenses.



Our reference manuals help research facilities ensure compliance by providing updates on the latest Federal regulations, while our industry compendiums provide executives with valuable information garnered from real-world studies, analyses, and fresh insight from widely respected opinion leaders on the most important new developments in the industry.

On Site 


Available worldwide, at your location, Barnett Educational Services' On-Site Seminars are a more cost-effective way to train a group of employees than other training alternatives.



How do you ensure that your training programs can adequately withstand FDA scrutiny?  Reviews of FDA 483s and warning letters indicate that the most frequently issued process deficiencies include areas that can be easily addressed with focused training programs.



Using a rigorous test question development and validation process, Barnett provides formal Good Clinical Practice (GCP) training and assessment for global clinical research professionals. Find out why companies are viewing Barnett’s assessment as a new standard for GCP Certification.


Does your department have critical training needs that need constant reinforcement? Barnett’s customized eLearning development services allow you to train large groups of employees in a consistent and cost-effective manner. Designed as self-paced modules, Barnett’s eLearning programs offer highly interactive, fun and engaging learning experiences for your teams.

 Virtual Investigator Meeting Icon   

Offering web hosting solutions that are seamless, ensure interactivity, and maximize the use of the web platform to create a memorable and outcomes-focused session. 

Acquisition Integration Services 


Successful integration of two companies requires strong leadership, vetted and clearly mapped integration plans, and excellent communication strategy.  People, processes, and technology must be considered throughout all phases of strategy development and implementation.  Utilize Barnett to ensure a smooth, successful integration during your merger or acquisition.

SOP Development Logo   

Effective Standard Operating Procedures (SOPs) are essential for organizations working in regulated environments.  Partner with Barnett to develop or update your Clinical Research & Development SOPs, then utilize our expertise to train your staff.  Meet company deadlines and maintain regulatory compliance with Barnett.

HIPAA and US Clinical Trials
Exclusive Interview with Sam Sather, MS, BSN, CCRA, CCRC 


SAM is the author of the all new HIPAA and US Clinical Trials: A Q&A Reference Guide 2014 and the long-time HIPAA subject matter expert to the Good Clinical Practice: Q&A Reference Guide. In this podcast, SAM tells us what’s new in the GCP Guide, and how the new HIPAA-specific reference guide delves deeper into the requirements, definitions, authorizations and enforcement of HIPAA. She’ll tell us how the book dispels common myths about HIPAA, and how HIPAA impacts risk-based monitoring activities like remote review of source.

Download Now 

GCP and Clinical Research Standards in Latin America, May 2014
Exclusive Interview with Anne Blanchard and Paula Valeria Casasco 


In this discussion, our regional experts address the growth, challenges, and opportunities of conducting clinical trials in Latin America. Specifically, we get insights into the common aspects of the regulatory process for the review and approval of clinical trials in Latin America, the challenges sponsors face in obtaining approval to conduct clinical trials, and how the region’s regulatory authorities monitor GCP compliance standards.

Download Now 

e-Clinical Trials, Electronic Records, and e-Data Regulations, May 2014
Exclusive Interview with Teri Stokes, Ph.D., GXP International 


This podcast is for those who seek guidance on the challenges and concerns related to computerized systems and their impact on site and sponsor personnel. In this interview, common sense computer validation services and training product expert Dr. Teri Stokes discusses her chapter in the GCP Q&A Guide, "e-Clinical Trials, Electronic Records, and e-Data Regulations,” including the two new FDA Final Guidance Documents related to Electronic Source Data and Risk-Based Monitoring.

Download Now 


Updates to the Good Clinical Practice Question & Answer Reference Guide are addressed in this exclusive podcast. In this interview, editor Michael Hamrell gives a sneak peek into the regulatory landscape in 2014, and the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. A must-have resource for CRAs, investigators/sites, auditors, compliance, legal, and other clinical research professionals, the Q&A Guide answers hundreds of questions about GCP.

Download Now 

Medical Device Development: Regulation and Law 2014 – Part 1
Exclusive Interview with Jonathan Kahan and Michael Heyl  


In Part One of this podcast series, the authors provide an overview of the 2014 edition of this must-have, authoritative text. This podcast offers a glimpse into the book’s comprehensive analysis of new FDA device legislation and over a dozen important new guidances, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the U.S. This interview provides an introduction to future podcast topics that will specifically address issues such as changes to the 510(k) process, the new refusal to accept policy, changes to the post-market side, the evolution of the de novo downclassification process, updates to the humanitarian device exemption requirements, new and significant changes to how FDA handles custom devices, as well as new trends in mobile applications and how FDA regulates medical device software.

Download Now 


The PAREXEL Biopharmaceutical R&D Statistical Sourcebook is the industry's leading resource for statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development – from product discovery, to R&D performance and productivity, to time-to-market analysis. Mark Mathieu is the Editor of the Sourcebook, and director of strategic research at PAREXEL Consulting. In this interview, he discusses the emerging metrics and benchmarks on the current state and direction of today's biopharm industry, industry activity in clinical development, metrics by therapeutic area, and clinical trials in emerging markets.

Download Now 

The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Exclusive Interview with Sam Sather, MS, BSN, CCRA, CCRC 


Happy Birthday, HIPAA! This exclusive podcast is with Sandra "Sam" Sather, MS, BSN, CCRA, CCRC, Founder of Clinical Pathways, LLC. Sam is the author of the GCP Question & Answer Reference Guide's section on "The HIPAA Privacy Rule and FDA-Regulated Clinical Trials." Hear Sam discuss the Omnibus HIPAA Rulemaking and HITECH, as well as strategies for sites, sponsors, CROs, and IRBs.

Download Now 

GCP and Clinical Research Standards in the European Union
Exclusive Interview with Dr. Beat Widler 


This exclusive podcast is with Dr. Beat Widler, the key contributor to this year's GCP Q&A Guide's Chapter on "GCP and Clinical Research Standards in the European Union." Hear Dr. Widler's take on issues such as global outsourcing, the pitfalls and opportunities related to global drug development, and the sharing of protocols and protocol standards across industry.

Download Now   

Click for more Podcasts » 


LinkedIn twitter Facebook  

January 2015 Catalog 


Good Clinical Practice 


Barnett Bookshelf 


PAREXEL Biopharmaceutical Statistical Sourcebook 2015/2016 (Hardcopy) 

PAREXEL Biopharmaceutical Statistical Sourcebook 2015/2016 (eStats)

Good Clinical Practice: A Q&A Reference Guide 2015 (Hard Copy) 

Good Clinical Practice: A Q&A Reference Guide 2015 (Electronic Edition) 

CFR ICH GCP Reference Guide for Medical Devices 2015 (Spiral Bound) 

CFR ICH GCP Reference Guide 2015 (Spiral Bound) 



Clinical Research Informatics World 

Clinical Informatics News 

Summit for Clinical Ops Executives  

Clinical Assistance Programs (CAP)  


CHI’s Clinical Trial Oversight Summit  

Insight Pharma Reports - Affiliated Reports 

Bio-IT World Bonus Edition