Compliance. It’s Never a Problem Until it’s a Problem

  These are the words I often share with clients when talking about compliance problems.  What I mean by, “It’s never a problem, until it’s a problem,” is that: It is difficult to foresee everything when it comes to compliance Most problems will not rear their ugly head until late in the game Don’t try[…]

Inside Investigator Meetings (Part 4 – The Root of the Matter)

Regardless of how one looks at the current state of investigator meetings, there is no question there is room for improvement. Like any improvement initiative, the first question the sponsor needs to ask is, “How does this benefit the bottom line?” The value of an investigator meeting needs to be properly defined and evaluated. Any subsequent[…]

Case Report Form Training

Case Report Forms.  In the world of clinical research, these forms are the basis for marketing approval.  Well-designed, they can foster faster, better and more accurate completion.  But be it paper-based or electronic, training users to use them can be a challenge. Even if trained correctly, there are often a series of delays from after[…]

Clinical Investigator Training and Site Staff’s Transcripts

Clinical investigator training as well as site personnel training has been part of the clinical research process for well over a decade now.  However, site personnel are constantly forced to retake training. This is because sponsors often do not recognize, nor do they have access to, completion credit for a given course or topic. This problem[…]

SOP Training for Clinical Research – Can it be Fun?

The mere mention of SOP training can make even the veterans among us shudder. But does it really have to be this way?  Does compliance training really differ from any other training?  Shouldn’t we apply the same principles of instructional design?  Does it always have to be the dull, boring, uninteresting, and monotonous “check here[…]