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.
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?
Protecting patients is at the core of clinical research and one of the ways research teams can ensure human subjects are protected is through holding up rules, regulations and standards set forth. Good clinical practice (GCP) is something that encompasses all these things because it is:
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, Infographic, Human Subject Protection, IMARC Research
In 2010, author Rebecca Skloot published the #1 New York Times bestselling book titled The Immortal Life of Henrietta Lacks. The book is a very thoughtful examination of the moral and ethical principles regarding the lack of consent on Henrietta’s behalf to donate her cells to science. It is filled with first hand accounts from her family and friends about their experiences that resulted from Henrietta’s unbeknownst scientific contribution.
Topics: Human Subject Protection, Henrietta Lacks, HeLa Immortal Cell Line
In previous blogs, we have discussed investigator oversight and how it relates to the overall protection of the rights, safety, and welfare of study subjects. We have also looked at investigator oversight and the relationship to device accountability. But how does oversight relate to the overall conduct of the research study?
Topics: Human Subject Protection, Investigator Oversight, FDA