This course is suitable for Principal Investigators, Sub-investigators and Study Coordinators and is a refresher course to allow for update and renewal of GCP training. The course will be highly interactive based on case studies and discussion sessions. Case studies will include the role of the PI in overseeing clinical trials, delegation of duties, source data, informed consent and safety reporting. The course meets the Transcelerate minimum criteria for training in ICH E6 (R2) for mutual recognition by sponsors and all attendees will receive a certificate of course completion at the end of the course.
The trainer, Eleanor Allan, has over 20 years’ experience in training clinical research personnel and is passionate, enthusiastic and practical in her approach. Eleanor trains Study Coordinators, Principal Investigators, academic researchers and sponsor personnel so understands the perspective of all parties. Eleanor is also an experienced clinical trials auditor and has first-hand knowledge of the current issues facing site personnel. The course will be interactive and include plenty of time for questions and discussions.
The GCP Refresher Course can be held onsite at your organisation/institution and tailored to suit your needs.
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Please contact Julie Robinson at Datapharm Australia for further information.