who's minding the shop?

If I were examining a site, I would key in on their policy for dealing with abnormal lab values.  Specifically, what happens when panic values are called in by the central lab?  Typically when a value is reported that is outside of 2 or 3 times the upper limit of normal, the lab will contact the site via phone and/or fax.  The problem is that most labs do not ask to speak with anyone working on the study, they are content with a fax sent over or even being put into voicemail.  That is fine for some scenarios because a panic value may not actually be of clinical significance.  However, what happens when the participant's safety is actually at risk?  Why should that participant's health be balancing on a sheet of paper sitting on a fax machine or a message stuck in voicemail?

I would envision a process where the person answering the phones takes note of the panic value and immediately notify the lead coordinator on the study or someone who is involved with the trial (a clinical manager would be ideal in this situation as they could triage the value to the appropriate party).  In this scenario phone calls from the lab about abnormal results would be resolved promptly and there would be no question about the response time to such alerts.  In my mind, if sites can be cited for not documenting the evaluation of labs expeditiously, then sites can also be cited for not responding to alert values quickly enough or not having a plan to promptly take care of such situations.  

On the other hand, central labs should take more responsibility for ensuring that alert values are resolved quickly.  They should have policies where phone calls should be taken and acknowledged by a person involved with the trial in some way.  Similarly a fax alert should not suffice because faxes can sit on the machine for hours without being checked.  

It's probably worth noting, however, that the clinical investigator is ultimately responsible for the safety of his/her trial participants, so if messages about lab values are left on a coordinator's voicemail for days, the investigator is the one at fault for not responding to them and taking action quickly.