You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
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
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
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
