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.
As monitors we spend a significant amount of time reviewing the essential documents at the site during a monitoring visit. The essential documents are usually housed in a Regulatory Binder or sometimes they are referred to as an Investigator Binder.
Topics: Monitor, Regulatory Binder, Essential Documents, Sites
As monitors, we spend a decent amount of time preparing for the visit – before we even head out the door. On the road, we’ve noticed that the most effective coordinators tend to be those who also prepare for the visit. Spending an extra hour or two before the visit can decrease the amount of queries, follow-up items and even the length of the visit itself. Before your next monitoring visit, consider asking yourself these five questions:
Topics: Coordinators, Regulatory Binder, Clinical Monitoring
Binders, huge files, and tons of paper….this is what researchers have become accustomed to. Some Sponsors have allowed sites to house certain items electronically, most often communication either emails between the site and Sponsor or IRB communication. But more often than not Sponsors require these items to be printed and housed in files or binders.
Topics: Research Coordinators, Regulatory Binder, Sponsors
The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority.
Topics: Sandra Maddock, Regulatory Binder, ORTHOWORLD