This module delivers a detailed overview of medical retina, uveitis, and vitreoretinal ophthalmic conditions including oncological disease of the eye.

You...

Medical Retina, Vitreoretinal, Systemic Diseases, Uveitis and Ocular Oncology (OPHT0038)

This module delivers a detailed overview of medical retina, uveitis, and vitreoretinal ophthalmic conditions including oncological disease of the eye.

You will gain knowledge of predisposing risk factors (including genetic), relevant systemic diseases and ophthalmic management algorithms, covering both common and rare eye disease.

The pathogenesis of these disorders will be explored, as will the clinical spectrum of presentation and the contemporary framework of therapeutic approaches and management, medical and surgical, which will be discussed in order to put the risks of the disease within the context of the risks and impact/s of various management options.

This module will introduce you to some practical aspects of clinical trial ethics and regulations. You will learn how each of the topics covered contribute to...

Protecting Participants and Introduction to Patient and Public Involvement (ICTM0001)

This module will introduce you to some practical aspects of clinical trial ethics and regulations. You will learn how each of the topics covered contribute to ensuring the safety, well-being, rights of participants and help preserve the scientific integrity of clinical trials. You will also be introduced to the important concept of having patient and public involvement in all stages of a clinical trial.

Each teaching day will focus on a specific topic relating to regulations and conduct:

Ethical approval, informed consent & Good Clinical Practice (GCP)
	Regulations
	Good Manufacturing Practice
	Pharmacovigilance & Safety Monitoring
	Patient & Public Involvement
 

At the end of this module, you will be able to:

Differentiate between appropriate and inappropriate trial conduct from ethical and regulatory perspectives.
	Explain good clinical practice and recommend appropriate courses of action to ensure good practice is set out and adhered to in given clinical trial situations.
	Evaluate good manufacturing and pharmacovigilance responsibilities for different types of IMP clinical trial and compose plans to manage those responsibilities.
Apply the appropriate clinical trial regulations to different patient populations and interventions to ensure patient safety and data integrity.
	Recognise the value of patient and public involvement and be able to justify PPI in all stages of the clinical trials process from an idea through to communicating clinical trials results.
This module is compulsory for students on the MSc Clinical Trials and the Postgraduate Diploma in Clinical Trials. The module is open to students registered for the Postgraduate Certificate in Clinical Trials, and to students from other courses on request.

‘E6(R2) - Integrated Addendum to ICH Guideline for Good Clinical Practice’. Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf.

 

 