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Fundamentals of Clinical Trials Online | Good Clinical Practice Training Course

Introduction to Clinical Trials - Online Training Course

This course is intended as an introduction to clinical trials for site staff who are new to clinical research and those from a non-clinical background. It focuses on the practical aspects of conducting a phase II or III clinical trial at a site. It will benefit those commencing a Study Co-ordinator or Sub-Investigator role in a multi-centre trial as well as staff at contract research organisations and sponsoring pharmaceutical firms who will be involved in clinical trials for the first time. It is also ideal for staff who need a grounding in the clinical trials process without the need for a full ICH GCP course.

  • Average study time:
    study time

    6 hrs

  • Personal development points (CPD):
    points

    6 points

  • Price:
    points

    £49.00

Please enter the number of licences required.

Course Details

  • Clear, attractive format.
  • Ideal for those new to clinical trials or with non-clinical backgrounds
  • Gain useful insights into the application of GCP from the author's vast experience.
  • Carries 6 CPD points.

Benefits for you

>>  Fully compliant

This course is an introduction to the international ICH-GCP guidelines, providing practical interpretation for those new to clinical trials. Learners also receive 6 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

>>  Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.

>>  Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training.  We can also offer generous group discounts on larger purchases.

>>  Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.

>>  Reliable and trustworthy

This course was written by Claire Herholdt (with 18 years’ of clinical trials experience, most recently as Independent Clinical Project/Program Manager at CDS Clinical Development Services Ltd.  Prior to that, she was Clinical Programme Manager at Biogen, following 3 years at Lundbeck as Clinical Study Manager). You will also stay up to date with any legislative changes in GCP as our training courses are constantly monitored, reviewed and updated. 

Course Syllabus

1: About this Course

2: Introduction to Clinical Trials

  • What are Clinical trials?
  • What is ICH GCP?
  • What is the Role of a Study Co-ordinator?...

3: Study start-up

  • Ethics Commitees
  • Institutional approval
  • Competent Authorities
  • Investigator's Brochure
  • Essential Documents...

4: Study Maintenance

  • Patient Recruitment & Informed Consent
  • Randomisation
  • Patient Assessment
  • Adverse events
  • Data Collection
  • Quality Assurance - Audits...

5: Completing the Study

  • Data Locks
  • Archiving...

 

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