"Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible."

 

At its core, GCP is about good planning and quality by design as part of a risk based management process.  The guideline was first released in 1996.  Now, 20 years later there is an update - The "Addendum".

 

"ADDENDUM

Since the development of the ICH GCP Guideline, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process.  Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, this guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated."

 

The information in quotation marks is the copyright of ICH

 

The PharmElearn group is proud to present to you our GCP Addendum elearning module.  We hope it will educate, entertain and inspire you.  The module makes use of humour and multimedia to try and fix the information in your memory as quickly and painlessly as possible.

 

There is a quiz as part of the module, but you are certainly allowed to "cheat" and use the GCH guidelines if you are at all uncertain.  At the end of the module, if you pass the quiz (a very easy quiz if you view the module as you go along), you will be issued with a certificate of completion which you can proudly hang on your wall, or show your boss.

 

So, go ahead, sign up now - it will be the best $50.00 you ever spent on training!