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 noted in our previous blog, in most cases when a monitor or CRO is brought into a clinical research study, the protocol, case report forms, and informed consent template have already been finalized. Moreover, some or all investigative sites may have already received IRB approval of their protocol and informed consent document. As noted in 21 CRF Part 812.42, the sponsor is required to have all study documents approved by the participating institution’s IRB. The IRB, on the other hand, is required to review clinical research activities, as noted in 21 CFR 56.109.
Topics: CRO, Monitor, IFC Checklist, IRB Approval
You did it!
Topics: Monitor, Record Retention, Clinical Research, IRB
At the site level, having a great working relationship between monitors and research coordinators can really make a difference in the performance of the site. To do this, monitors walk a fine line between being personable and relatable, but also being respected and trusted.
Topics: Monitor, Research Coordinator, Relationship
Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study. What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC). Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked. Some of the major responsibilities of the CRC are:
Topics: Informed Consent, Monitor, Clinical Research, IRB