An Alternative To The Free Online GCP Training by Quintiles

• People also need recommended FDA GMP online training courses offered by SkillsPlus International Inc.

Free Online GCP Training

Updated 4/10/2015:

The Quintiles GCP training is no longer available to the public for free.

I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

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Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'

Upon completion of the program the participant will be able to:

1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
3. Apply ICH and local regulations to specific research activities at the clinical site

Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked. 

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