As monitors, we often encounter sites that utilize Standard Operating Procedures (SOPs) to help ensure clinical research trials are consistently conducted according to FDA regulations.  According to the International Conference on Harmonisation (ICH), SOPs are “detailed, written instructions to achieve uniformity of the performance of a specific function.”  While most would not argue the value of SOPs when it comes to the successful completion of a clinical trial, it’s important to take a closer look and think about them critically prior to implementation.

In the movement to “go green” and reduce overhead, some clinical sites are moving away from printing every piece of correspondence regarding a research study.  While this may reduce the cost for printer/paper toner, not to mention the time to print and file all correspondence, is this a wise decision?

CBS recently revisited an important consumer health topic – the misrepresentation of stem cell treatments on the internet. In the 60 Minutes investigation, Dr. Joanne Kurtzberg of Duke University comments that there are ‘huge dangers’ of injecting unregulated stem cell treatments into a patient’s blood or spinal fluid because “little fragments and debris would get trapped somewhere in the blood stream and could cause a stroke, or in the brain [they] could cause an inflammatory reaction.” You can read the transcript here, and find the videos from the previous installments of the story from 2010 here and here.

Today there is no national standard for the competence or credentials of healthcare vendors. There is no specific requirement for licensure, certification, registration, or education of healthcare vendors. However, the Joint Commission recognizes a few standards that affect anyone who may directly impact the quality and safety of patient care. Clinical monitors are not directly involved in patient care, but we can have impact on the safety and quality of the care of patients being treated in clinical research trials. In fact, GCP is our standard for ensuring data is accurate and credible and that trial subjects are protected from harm. Because of this influence, some healthcare institutions are considering monitors as healthcare vendors. Thus we are faced with the same dilemma the pharmaceutical and medical device representatives are dealing with at this time – vendor credentialing.