Foundation Course in Clinical Research (Certificate in Clinical Research & GCP) - UK

Foundation Course in Clinical Research (Certificate in Clinical Research & GCP) - UK
Product Code: Foundation Course in Clinical Research: Basics - UK
Price: £950.00

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A 2-day interactive course covering the fundamentals of clinical research & GCP. Ideal for the new or inexperienced and essential for those wishing to attain certification. Faculty of Pharmaceutical Medicine (Royal Colleges of Physicians of the UK) has awarded 13 CPD credits to this course.

We use visual, auditory and kinaesthetic learning methods to make the course fun and enjoyable.

Sample programme

Objectives and Course Content

Participants of courses learn in different ways. Our foundation course has been designed to ensure that all the visual, auditory and kinaesthetic methods of learning are incorporated. We have drastically reduced the use of PowerPoint presentations and included non-threatening activities. These both enhance learning and make the course far more enjoyable for the participants.

Professor David Hutchinson helping one of the course attendees

No prior experience is required but participants will gain most benefit if they have worked in the field of clinical research for at least six months prior to attendance. At the end of the course participants should have a thorough basic knowledge of the clinical trial process, be aware of the need to comply with GCP and be aware of the most important GCP responsibilities.

The course has attracted a vast number of enthusiastic comments on our new teaching style, including ....

"Finally a course where you don't just sit down and listen for hours all the time. Excellent with interactive sessions — it certainly kept my attention".
"Thank you very much — I never thought learning GCP could be so interesting"
"A fantastic course with extremely competent teachers who know how to explain the topics in an easy to understand way"

 

 

This course covers and participants will be made aware of.......

  • the process of the development of a new medicinal product through the various phases of clinical research (Phases I to IV and PMS)
  • the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use)
  • plain language explanations of abbreviations, methodology and terminology including study designs (parallel group/crossover), blinding methods, use of placebo
  • introduction of GCP and its implementation by standard operating procedures
  • the ICH process and products
  • the clinical trial process from planning to final report and GCP requirements at each stage
  • role of the biostatistician
  • subject protection in clinical trials including the role of the Declaration of Helsinki, GCP requirements relating to the consent process and obtaining an ethics committees opinion
  • safety monitoring and reporting (adverse events, adverse reactions, serious adverse events, expedited reporting, and basic requirements of the ICH E2 guidelines)
  • investigator's GCP responsibilities
  • selecting investigators and performing site assessments
  • pre-study briefings, routine trial monitoring, study closure
  • data collection and monitoring including source data verification
  • study documentation including content of the trial master file and archiving
  • role of quality assurance and consideration of common audit/inspection findings

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