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Safety First: Managing Participant Safety in Clinical Trials

September 19, 2016

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Who is this course aimed at?

Investigators, study coordinators, research nurses and any person in the clinical research team who is involved in the safety management of human participants in a clinical trial.

What will be covered?

  • The seven domains of an Adverse Event
  • The philosophy and application of SAE reporting
  • Setting up optimal systems for monitoring, reporting and follow-up of safety events
  • Case scenarios and practical examples

To get the most out of this course, we highly recommend that participants have attended a prior GCP course and preferably the Crede Nuts & Bolts Course (this is not a requirement).

What is the focus of the course?

The focus is on applying GCP principles in the field, on the translation of policies and guidelines into practical steps, and a pragmatic methodical integrated approach. We will explore how principles of participant safety are applied in the field.

What is the format of the course?

The course is interactive, in a small group workshop environment. Case scenarios and real life examples are discussed together with the principles and how the principles guide our daily practice in clinical research.

Who are the facilitators?

CREDE is known for its customized and interactive courses in, amongst others, GCP, GDP and consultancy work with clinical research sites. The facilitators have ground-level experience combined with in-depth knowledge and are proficient in this style of training. The facilitator is an experienced investigator in clinical trials with firsthand experience.

What about cost and logistics?

This is a half day course, from 13h00 to 16h30. Lunch/Coffee/tea is included.

Participants have the option of combining this course with the Crede Nuts & Bolts Course which runs over the preceding two and a half days. The combination of these 2 modules is ideal for clinical investigators who desire training in clinical trial operations as well as the participant safety aspects.

CPD points and a certificate of attendance will be issued (useful for CVs). Cost: R910.00 VAT inclusive

For further information and to book your place (limited spots available!) contact Marijke or Hennie Geldenhuys (marijke@crede.co.za, henniegel@crede.co.za).

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