To help you gain a better understanding of what is required for a clinical trial to proceed, I have decided to start a series on Informed Consent which in my opinion is the most important part of monitoring. I will cover the definition, and requirements, as well as specific tips and nuances for monitoring Informed Consent Forms (ICFs). I will also cover the ICF approval process from both a Sponsor and CRO stand point. For this post I will begin with defining what Informed Consent is: Informed Consent….
“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 consent form.”
ICH-GCP 1.28 (This is an important section in the ICH-GCP handbook) Before any research on human beings, each potential subject must be informed of the purposes, methods, sources of funding, any possible conflicts of interest, and institutional affiliations of the researcher, as well as the expected benefits and potential risks of the study. The subject should be informed of the right to not take part in participation in the study or to withdraw consent to participate at any time without any punishment. After ensuring that the subject has understood the information, the physician (Or Study Coordinator who has been trained on the protocol) can then obtain the subject’s freely-given informed consent in writing. This is done by the subject signing and dating the ICF. -Sara
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