Medical Records?

There are quite a few opinions out there on whether or not clinical research sites should request medical records for research participants that are not patients of the research facility.  Some people argue that without medical records there is no way to complete assess an individual's eligibility for a trial and there are absolutely no exceptions to this.  On the other hand some sites may argue that medical records are not necessary unless specific documentation about a condition (ie arthritis, cancer, MS) is required.  These sites may say that most records contain lots of extraneous information that is not clinically relevant to the trial, but must be documented in such a way that it greatly waters down the quality of the data from the site.  Not to mention that it leaves plenty for an overzealous monitor to scrutinize for possible study entry violations. 

So who is right?  The FDA does not explicitly require that copies of medical records be obtained for clinical trial participants, but good clinical practice would strongly advise that attempts to request records are made prior to enrolling a subject in a trial.  The federal regulations do mention that a clinical investigator needs to collect a complete and accurate case history of a subject and that this history does include past/current medical conditions, but those rules do not indicate how this history should be acquired.  In my opinion a site is more than welcome to use a medical history interview in the clinic to acquire a case history, but there should absolutely be some sort of documentation signed off by an investigator that the interview was deemed to be accurate/complete if this practice is utilized.  However I think that if copies of medical records can be obtained, that is always preferable to ensure total collection of a case history and to protect the site in the event of an audit (even if it does open doors to much more work by site staff in recording extra medical conditions, having an investigator review those records, and fighting with monitors over questionable findings).    

I guess the take home message here is that while the clinical investigator is ultimately responsible for the eligibility of research participants, there is no substitute for outside, objective information that verifies a subject's case history.  Most clinical research staff (investigator's included) are truly trying to do a good job with honest data collection and documentation, but there are those out there who will leave out exclusionary conditions or medications just to see a person enrolled in a trial (remember, this is one reason that audits occur). With all the discussion lately about the FDA tightening the reins on clinical research, it's more important than ever for research sites to ensure that GCP is followed tightly and medical records are an excellent way to prove this.