So, you’re the new Monitor, new kid on the block, etc. – doesn’t matter if you’re a newbie to the CRA arena (think gladiator) or you got assigned to a new clinical site; you have incredible power! You can wield the sword of ALCOA and bring sites to their knees; at the very least they surrender the charter of CAPA, at the very worst their data is branded and they get thrown to the lions (think BIMO).

You speak the universal languages of GCP, GXP, ICH, HIPAA and FDA and wear an armor of morality and ethics with a shield that defends the rights of research subjects but the most important weapons?

Common Sense and its partner Intuition/Gut Instinct.

Descartes stated “everyone has enough common sense but that is not enough, there is a method that must be followed”; and that method(s) is still being debated today.  Merriam-Webster defines it as ‘sound and prudent judgment based on a simple perception of the situation or facts’. Researcher Gary Klein, PhD reveals that, in fact, 90 percent of the critical decisions we make is based on our intuition.

While pouring over progress notes, flowcharts, records, lab slips, photographs, images, etc., whether it is paper or electronic that nagging question is always in the back of your mind

• Do I truly have enough evidence?
• Could it be a cut and paste error (EMR)?
• Do I take charting by exception (CBE) at face value?
• Should I be finding every single matching digit for digit in the source and the CRF?
• Or, a Monitor’s worst nightmare – is this a real patient?

Trust your inner voice. If you feel the tinniest bit uncomfortable, check it again – you’ll be glad you did.  When in the trenches you’ll be able to say with 100% confidence that the monitoring battle was won!

Have any good ‘war’ tips to share?

Susanne Panzera
Clinical & Quality Affairs