Good Clinical Practices (GCP), more specifically in regards to informed consent, regarding pharmaceutical and/or medical device clinical studies/trials. There needs to be a broad introduction regarding what GCP is, what informed consent is, and why it was implemented with examples (such as the Declaration of Helsinki). Then move into the specifics of patient informed consent and the required 24 elements of the consent form (attached), and whether there are any differences across disciplines (medical devices, pharmaceuticals, and biologics). Additionally, there needs to be reference made regarding comparison and contrast to good clinical practices between other countries in the International Conference on Harmonization (ICH). Also needed is reference to the U.S. Food and Drug Administration (FDA) regarding the Code of Federal Regulations (CFR), specifically: • 45 CFR 46, Protection of Human Subjects • 21 CFR 50, Protection of Human Subjects • 21 CFR 56, Institutional Review Boards • 21 CFR 312, Investigational New Drug Application • 21 CFR 812, Investigational Device Exemptions The conclusion needs to summarize the details and describe what that means to us and why. How it was helpful, why we needed it, where it was early on compared to where we are now, and where we are going with it. I will upload any supporting information I have that may be helpful.
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