Introduction to Clinical Research & GCP

Introduction to Clinical Research & GCP
Tuesday 24th October 2023, 10.00am to 3.15pm, including a 45 min lunch break at 12.00 noon.
Venue: Copenhagen

This is an ideal foundation course for those involved in all aspects of clinical trials. This course needs no previous experience. Everything is explained in plain language.

The course will consist of presentations, poll questions, interactive tasks and discussion.

A PDF course book will be provided. This will be used during the course to undertake individual tasks.

Course notes will be provided in PDF electronic form.

Content includes:

• Phases of research and types of trial
• Common trial designs and terminology.
• GCP and who it applies to.
• GCP principles.
• Study protocol and compliance
• The critical path of the clinical trial – each step explained from planning to publication.
• GCP requirements relating to …
  - Investigator site and suitability.
  - How patients are protected in clinical trials :Helsinki, consent and ethics.
  - Investigational Medicinal Product (IMP).
  - Safety reporting.
  - Data collection, reporting and quality.
  -Document generation: content and management of the Trial Master File.
• Audits and inspections explained.

 

'It has been a pleasure to attend such an excellent course. I really enjoyed it and learnt many relevant information about methodology and terminology in Clinical Research.

Please extend my thanks to Prof Dr David Hutchinson and Dr Colin Wilsher, they are excellent speakers!

Thank you again for the great course, I would certainly recommend it and I hope to be able to attend other courses in the future.' - ET

It was one of the most interesting, good, useful and nice trainings which I ever had! Thank you! -  KP J&J

This course will be delivered face to face, subject to any public health issues at that time *

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