Introduction to GCP is TransCelerate-endorsed and facilitated by Dr Emma Kirk, Ms Charmain Strauss, Ms Belinda Fazekas, Dr Rayan Sala Moussa, Ms Jessie Hao and Prof Meera Agar who are TransCelerate-certified.

We invite you to participate in this dynamic and interactive training if you are a UTS staff or student currently involved with, or planning to be involved with, clinical trials or clinical studies which prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. All members of the research team (investigators, clinical trials staff, and site investigators) must hold appropriate and current training in Good Clinical Practice (GCP) as provided by a TransCelerate-approved provider.

GCP training will provide you with a foundation to help you carry out your roles and responsibilities in the research process with confidence. The content and approach of the day is focused on the practical aspects of applying the quality standards that are integrated into GCP to ensure that the rights, safety and well-being of research participants are always protected.

IMPORTANT:

In order to successfully complete GCP, you are required to attend all five sessions on the day. If you can only partially attend the training, you will need to wait until the next GCP training is available to complete any missing incomplete/sessions before we issue a certificate.

The online training will cover:

the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
the roles and responsibilities of different individuals and organisations in clinical research
regulatory applications required before clinical research can be started in Australia
essential documents and the purpose of maintaining a trial master file
informed consent (and equivalent processes where appropriate) and the roles and responsibilities of those involved in this process
correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
correct reporting requirements that ensure participant/patient safety

Workshop Program:

	Time	Session
	10:00 am - 12:15 pm	S1: The Standards and why we have them S2: Study Set Up – Responsibilities, approvals and essential documents
	12:15 pm - 1:00 pm	Lunch break
	1:00 pm - 3:30 pm	S3: Informed consent S4: Case Report Form, Source Data and Data Entry completion S5: Safety reporting Assessment