IMARC clinical monitors are constantly on the go monitoring in the field, from California to Connecticut, Vancouver to Miami. The monitors are no strangers to airport security lanes and the Transportation Security Administration agents (TSA). Some may even creatively compare monitors to TSA agents. Both groups of people are required to be familiar with federal regulations. The regulations exist to allow for monitors and TSA agents to execute their primary role; ensuring safety. Monitors ensure the safety of subjects in clinical trials and ensure compliance to 21 CFR 812 (device) or 21 CFR 312 (drug). TSA agents ensure safety of travelers and flight staff as well as ensure compliance with FAA regulations.
Our monitors know that there is A LOT to know in clinical research to protect patient safety and ensure compliance.
- Federal regulations
- Investigational plan
- IRB requirements
- Agreements between the sponsor and the investigator
- ISO 14115
- Good Clinical Practice
- NIH guidelines
- Sponsor requirements
- Internal site policies
To help sites, sponsors, and investigators navigate through the regulations and secure compliance, IMARC monitors use the FAIR Shake™. The FAIR Shake™ is an easy and comprehensive way to work through challenging situations in clinical research in which the solution or answer may not clear and straightforward. The FAIR Shake™ allows our monitors to be consistent, thorough monitors no matter what study, site, or problem they are working on. One answer at one site for one study might not be the same answer for another site for the same or different study. So how does IMARC keep it all straight? Give your question The FAIR Shake™:
- Federal Regulations
- Agreements between the sponsor and investigator
- Investigational Plan
- Requirements of the IRB
As a benefit of traveling to different sites across United States and Canada, our monitors often are treated to TSA Pre-Check, a new program offered at select airports designed to streamline the security process for those that are frequent fliers. Those selected for Pre-Check can keep their shoes and are not required to remove their computers from their bags. An IMARC monitor asked a TSA agent this morning, on a trip to visit a site in Chicago, “Am I able to keep on my coat?” The first TSA agent replied “’It’s up to the agent back there”-and pointed to the screening station, where 3 agents were standing. How was I supposed to know which one to ask or which agent makes the decision? What if they switch off making the decision and each one provides a different answer to different travelers? If I was at a different airport, is there a different person that gets to make the call if my coat stays on or not?
One of the cornerstones of IMARC’s monitoring approach is that all monitors are consistent and monitoring practices are strongly founded in the regulations. Monitors often hear sites complain that it is burdensome when one monitor wants it one way and then another monitor wants it a different way. This compliant of inconsistency between monitors is just one reason that the The FAIR Shake™is so valuable. It is not what the monitor wants; it is what is in Federal Regulations, Agreements between the sponsor and investigator, Investigational Plan, or Requirements of the IRB. There is no “M” in FAIR Shake™ for “Monitor Preference”.
To conclude our monitor’s experience, the TSA agent at the scanner directed the monitor to leave her coat on, stating “that’s a raincoat, you must take it off”. Oh really, says who? There was a sign on the wall above the bins that indicated “light coats” could be kept on the traveler. This lead the monitor to practice the FAIR Shake™ exercise in her head for the TSA again:
- Federal Regulations: Is it an FAA requirement that raincoats are removed?
- Agreements between the “sponsor” and “investigator”- What types of commitments/agreements has TSA made to the FAA? Would removal of raincoats be within the language of such agreement?
- Investigational Plan: Surely there is a protocol for security procedures that the TSA are required to know or reference often when questions arise relating to security screening. Is the restriction of raincoats clearly noted in the security screening protocol?
- Requirements (of the IRB): Each airport may elect to put in additional provisions to further extend the safety of its travelers, similar to the function of an IRB. Does the Cleveland Airport require that raincoats be removed?
As far as we know, the FAA does use the FAIR Shake™ method when travelers have tough questions, like “can I keep my rain coat on”, that don’t have straightforward answers. But maybe they should! Have you had a question or issue present itself recently where you could have used the FAIR Shake™ method? Want to learn more about the FAIR Shake™, down load our whitepaper!
Photo Credit: FlickrJunkie