Compliance In Focus

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.

In order to run a well-controlled compliant study at the site level, one must ensure that the study team has been trained, and is knowledgeable on the rules and regulations. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities. The research coordinator carries out many of the day-to-day activities and touches nearly every study milestone.

In an article published last week in MedCity News, the author quoted a survey, stating that clinical trials would get more participants if doctors informed their patients about them.