Advice for what to do about a troublesome PI
This is going to be a long post. Lots of details that I feel are relevant.
TLDR: Horrible investigator. Not only rude, but questionable data collection and safety review procedures. Looking for suggestions on how to proceed or if I should just look the other way. Concerns about safety of participants & data quality.
Looking for advice on what to do (or not to do) about an extremely difficult PI. I want to emphasize that, while this PI is egotistical and condescending, I'm more concerned with the way they conduct their parts of the trials we conduct. A little bit of background: I work for a large CRO with multiple sites. Each site has 1 medical director and 3-4 other investigators reporting to them. Each trial is assigned 1 principal investigator out of the 4-5 at each CRU. When all of our prior PIs quit about 2 years, multiple investigators from other sites were temporarily relocated to our site until they could hire a new team. The first of our new investigators hired was our new medical director, who was great at first, but within the span of a few months became almost a new person.
First, their ego is insane. Extremely rude to technicians, nurses, paramedics, CRCs, etc. They've developed a reputation, and it seems most people have experienced them being condescending or rude. While this isn't that big of a deal (because haven't we all dealt with an egotistical doctor?), they often refuse to explain any of their decisions. If we disqualify a participant from a trial, the participant often wants to know why (this is many of their primary sources of income), and their response is usually along the lines of "because that's how I say it should be". I'm a CRC and am the one who communicates with our participants, so it puts me (and my fellow CRCs) in a really tough spot because we don't have an answer to give to the participant. We often get chastised or reported to our own manager that we're "questioning their judgement", something that they think we shouldn't do as CRCs. To clarify, we're not questioning judgement, but it's common for our PIs to miss certain parts of protocols, so we often point things out to help out our PIs. We routinely do this for the other PIs at our site, all of whom thank us for helping them and are very appreciative.
This investigator also seems to think that whatever they say goes. To a certain degree (mostly for safety things), I agree, but there are often certain protocol requirements that they will blatantly ignore. While I can't say that this definitively is the reason, it's worth noting that any protocol requirements they ignore (and thereby cause PDs), require them to do additional work. I have a study with them that requires a microscopic urine exam performed only if certain UA parameters are positive. Our lab doesn't automatically do it, requiring the investigator to order the test upon review of the UA. This investigator refuses, and we have lots of PDs because of it. When I noticed this was being missed, I tried to get the micro test done on a few UAs that were just collected that day (viability is only 24-hours) but got a nasty email from this PI saying that I need to confirm with the investigator before ordering labs. 100% agree, but they were also gone for the day (and are never reachable by phone or email after hours), and my actions did save us several PDs. They argued that this wasn't needed, but after raising the question to our client, the client confirmed that the micro exams were needed.
Second, there have been a few instances where I question the data they collect. For example, we recently had a study where they needed to perform a brief physical exam on 15 participants. I'm not a doctor and although it was not a full PE, the brief PE included assessments of 4-5 major organ systems. This PI documented completing several of these PEs within the same minute. For example, participant 1 had it documented as being completed at 19:01:05, while participant 2 had it documented as being completed at 19:01:20. They did this several times. I did point this out to the CRA, who said they agree, it seems very suspicious, but I don't think they will do anything about it. This investigator has also had similar behavior with our in-house CRAs, to the point where the PI told their manager to tell all the in-house CRAs that they should not directly communicate with the PIs; instead, he wants them to talk to the CRC to relay the message to the PI. Most of them ignore this though.
Third, there have been multiple instances of safety reviews being missed before approving a participant to proceed with study. I've only ever worked for this 1 CRO in my entire career, so I'm not sure how it works at other places, but we complete screening assessments, have the PI review and approve at screening. Then we check them into the CRU the day before dose and have the PI review and approve any safety assessments performed before dose before actually dosing them. It has happened many times where things are missed. Examples include them approving participants to dose who are still missing protocol-required safety labs (one was an entire chemistry panel, one was a pregnancy test, etc.). There was one time they approved several participants to dose before documenting review of the predose ECGs, and the most recent instance was approving 2 different participants to dose despite their medical history containing exclusionary things and another lacking a thorough pregnancy history (required per protocol) even being collected. Since this continuously happens at least once every other month, I'm genuinely concerned that they're not even reviewing things. Completely understand that mistakes happen and we're all human, but this is a recurring issue.
Looking for advice on what you would do in this situation. Most of these studies aren't actually ones that I'm assigned to as a CRC. However, I am the only senior CRC at my site and most others have <1 year of experience, so they may not realize that this is a trend with this PI. The PI is our medical director, and their boss is located remote in a different country and is the head of all medical affairs in our company. I've never met or even talked to this person, but I did consider sending an email to them to express these concerns. Lastly, since we had many other investigators come to our site from other sites previously, I am actually very close with one of the medical directors at a different site. I considered bringing these concerns up to the other medical director and getting their advice.
I'm just at a complete loss. Is this none of my business? Or is it my obligation to bring up these concerns since it's regarding safety/quality?