Over the past seven years I have traveled all over the United States and Canada and have even been to Japan once. Due to the great distance, airplane has been the most expedient method for me to travel. Given that, I have looked out of hundreds of airplane windows and am always enamored with the view. I never tire of trying to identify where I am, especially as I get closer to Cleveland Hopkins International Airport. I only live about 25 miles from the airport and really, how hard can it be to find a landmark from the sky? For whatever reason, I have the hardest time trying to do this. So you can imagine my aggravation when my husband accompanied me on a trip a few years back and on our decent into the airport he started to rattle off all of these landmarks and our location. Did I mention my husband has flown in an airplane about six times in his entire life? After I was done being aggravated at his skill, I really enjoyed finding landmarks, too. It was so easy once someone gave me a starting point. Wearing your ‘auditor’s hat’ during your monitoring visits can be just as easy and fun. You just need to have the right starting point and tools.
To start with, techniques used by auditors include knowing the ‘rules of the game’. This is done by knowing the governing regulations, the protocol you are monitoring, the contents of the investigator’s agreement with the sponsor, and any conditions of approval by the IRB.
As the federal regulations in the US can be vague, review of recent warning letters posted on the FDA website (http://www.fda.gov/) can provide insight as to how the FDA is currently interpreting the regulations that oversee sponsors, IRBs and clinical site investigators. Review them for a year or two and make notes of trends, i.e., the top five citations for clinical investigators. This working knowledge of the FDA warning letters is a valuable tool for a monitor.
When reviewing the protocol, play the devil’s advocate and look for labs or tests or other study procedures that are not typically required as standard of care for that disease process. These will be items that the investigative sites will have difficulty complying with. Interview your research coordinator and principal investigator and help them identify the labs, tests, and follow-up procedures that are not customary for their site. Go the extra mile and assist the site in ways they will ensure the protocol required labs, tests and procedures won’t be missed. During your future monitoring visits check to see if their action plan is effective.
Prior to monitoring at a site obtain a copy of the IRB standard operating procedures (SOPs) as they relate to approval. SOPs of particular importance are those concerning consenting the subject (i.e., who can consent, where are they to be consented, etc.) and adverse event and protocol deviation reporting requirements. Review them with your research coordinator and during your monitoring visits ensure they are being followed. Request a current copy at least yearly to ensure no changes have been made.
Finally, utilize tables and spreadsheets to identify trends and to confirm staff listed on the delegation log have been trained on the protocol (and revisions), have product training (if required), have IRB approval to participate on the study (if required), and have documentation of experience to participate on the study prior to them conducting any study related procedure, including consenting subjects.
If you have used auditing techniques while monitoring, please share your experiences below.
Photo Credit: Spixey (feeling the cold)