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Compliance In Focus


Newest Post

Posted by Stephani Hulec on Wed, Jun 17, 2015

Essential Document Review, What are you Looking For?

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

Posted by Stephani Hulec on Wed, Mar 04, 2015

ICF Checklist After IRB Approval Too? Why Bother?

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

Posted by Brandy Chittester on Wed, Mar 04, 2015

Record Retention: Just How Long Do We Keep All This Stuff?

You did it!

Topics: Monitor, Record Retention, Clinical Research, IRB

Posted by Brandy Smith on Wed, Mar 04, 2015

Building the Monitor and Research Coordinator Relationship

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

Posted by Sandra Maddock on Wed, Mar 04, 2015

How Important is a Clinical Research Coordinator?

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

Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.