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Posted by Brandy Chittester on Wed, Mar 04, 2015

Documentation of the Informed Consent Process – What is Required?

We have had this discussion numerous times over the years.  Many believe that the informed consent form is documentation enough.  On the other hand, others would like to see all consent processes documented with a progress note, in addition to the consent document.

Topics: Informed Consent Process, Documentation, Protection of Human Subjects

Posted by Sandra Maddock on Mon, Nov 06, 2017

Informed Consent Checklists - Helpful Hints!

Informed consent checklists, just like the informed consent, are more than just a document, but rather can be a process. To begin, what is an informed consent checklist and how do you use one?

Topics: Informed Consent, 21 CFR 50.20, Protection of Human Subjects

Posted by John Lehmann on Wed, Mar 04, 2015

Safety > Efficacy?

Focus on safety, and leave the question of efficacy to post-market studies; this recent recommendation comes from the former commissioner of the FDA, Andrew Von Eschenbach. As imagined, this suggestion has created quite a stir in the industry and many are weighing in with their thoughts.

Topics: Safety and Efficacy, Medical Device Maker; Post-Market Studies, Protection of Human Subjects

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