Virtual “Introduction to Clinical Research & GCP"             
Tuesday 24th March & Wednesday 25th March 2026

• This course will be delivered in two x 4-hour webinars.
• A PDF course book will be provided. Participants should print the course book in advance – this will be used during the course to undertake individual tasks.
• The course will consist of presentations, poll questions, interactive tasks and discussion, and followed by an online quiz.

 Session 1

·        Types of clinical research e.g. interventional, real world etc

·        Phases of research and terminology.

·        How are clinical trials regulated and why?

·        What is GCP, who does it apply to and key stakeholders?

·        GCP principles.

·        Sponsor definition and responsibilities

·        The critical path of the clinical trial

·        Study protocol and compliance

·        Considerations in trial design

·        Service providers

Session 2

·        Session 1 recap

·        Risk assessment and oversight

·        Investigator responsibilities

·        Investigator site and suitability.

·        How patients are protected in clinical trials: Helsinki, consent, ethics and PPI, DEI

·        Investigational Medicinal Product (IMP).

·        Safety reporting.

·        Types and phases of monitoring

·        When things go wrong – deviations and breaches

·        Data collection and analysis

·        Transparency – registration and reporting

·        Document generation: content and management of the Trial Master File.

·        SOPs, Audits and inspections

The content of each session is a guide only. Topics may be switched between sessions to provide participants with the best learning experience but overall content will remain the same.

'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