|23 Sept. 2019
|17:00 - 18:00
ICH GCP defines informed consent as:
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form (§1.28)
In today’s environment information is given in many forms, commonly via electronic, computerised means. Every day we accept policies, terms and conditions by the ‘click’ of a button to quickly access the information we need to support decision-making in our lives. On-screen information plays an integral part of learning, with even young children accessing learning materials from school websites to supplement descriptions and discussions with their teachers.
In clinical trials, however, paper forms persist; as trials become more complex in their designs, and therapies more directed to specific patient populations, the paper informed consent and patient information form remains the ‘trusted’ mechanism for documenting that the informed consent process has taken place.
Why is this? Regulators and clinical trial researchers agree electronic informed consent processes are not prohibited by legislation, provided the principles of the informed consent process are adhered to.
EFGCP is proud to be supported by the UK Medicines and Healthcare products Regulatory Agency (MHRA) GCP Inspectorate and UK Health Research Authority (HRA) amongst our eminent guest panel for a lively presentation, discussion and debate on the topic.
We will hear from Regulators, Industry and academics about the ongoing debate that will help raising awareness amongst stakeholders for further dialogue and potential solutions. This will be followed by a Q&A discussion where you will be able to ask questions to our panel.
Introduction to the Webinar
Moderator(s): Louise Mawer, EFGCP Audit WP Chair
Presentation “eConsent in Clinical Trials of IMP”
Clive Collett, HRA
Jennifer Martin, MHRA
Panel discussion & Q&A session
Clive Collett, NHS, UK HRA
Ingrid Klingmann, EFGCP Chairman
Jennifer Martin, MHRA
Matt Jones , Digital Quality Associates
End of the Webinar