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.
The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients. A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are responsible for continuing review of ongoing research to ensure that the rights and welfare of human subjects are protected.” That’s a tall order!
Topics: Patient Protection, FDA, IRB
Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?
Topics: Good Clinical Practice, Patient Protection, Clinical Research
FDA regulations can seem all encompassing at times, especially when trying to run a clinical trial in compliance with the various rules and standards. While many in clinical research would not argue that there are not enough regulations governing clinical research practices, the question remains: Are there too many gray areas?
Topics: Ethics and Research, FDA Regulations, Patient Protection