Clinical Research Monitoring is a vital part of the Clinical Trial process, and one of the most prominent skills you’ll find in an effective monitor is exceptional communication.  Whether you’re contacting a site, writing a confirmation letter, drafting a report, or talking to an investigator, your communication skills, or lack thereof, will determine how well you are perceived and will ultimately affect your effectiveness in the clinical trial process.

You may have heard the term Sponsor-Investigator before, but just who are they and what do they do?  Just as the title suggests, a Sponsor-Investigator is someone who both initiates (sponsors) and conducts (investigator) an investigation.  This may sound simple, but in actuality, the role can be quite complicated.  However, like anything else, with proper preparation and support it can be accomplished.  Sponsor-Investigators are a rare breed of extremely intelligent, hardworking people who are on the cutting edge of scientific advancement in their respective fields.  They are so committed that they are willing to do essentially twice the work to bring new technologies and advancements to the medical community.

According to 21 CFR 812.110 an Investigator is responsible for conducting an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.

As questioned in this issue of the Journal of Clinical Research Best Practices - why does the clinical research industry have such a high turnover rate for clinical research personnel?

During a recent monitoring visit, I came across a scenario that challenged my efforts to ensure compliance with the Institutional Review Board’s (IRB) policies.  For background, an East Coast University/Hospital has a new area of outsourcing for the studies that are being conducted at their institution. The local IRB reviews all Phase I/ II studies and all studies that are funded by the National Institutes of Health (NIH). Phase III and IV trials are outsourced to a central IRB.

This blog was written by a newer monitor with IMARC Research.  This is her experience, and certainly not representative of all research coordinators and monitors.  We thank her for sharing this, and hope others who have made the similar transition will chime in with their experiences!

Oftentimes when one thinks of clinical trial monitoring, he thinks of a monitor making periodic site visits to the hospital or institution where the trial is taking place.  During these visits, the monitor verifies the data collected with the site’s source data and study documentation, among other duties.  These periodic site visits are often scheduled and made on an elapsed duration.  For example, some sponsors/studies require a monitor to be on site every 4-6 weeks to keep tabs on the data.  Seems like a pretty straightforward, streamlined, routine process, right?