Compliance In Focus

Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study.  What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC).  Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked.  Some of the major responsibilities of the CRC are:

The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and lead to sites being less inclined to follow regulations. The coordinator-monitor relationship is critical to the research process as it serves as a link between sponsors, investigators, and regulatory authorities.

During a company meeting recently, talk turned to Delegation of Responsibilities (also known as Delegation of Authority, or DOA) logs. It is common practice for investigators to delegate certain study tasks to other members of the study team (coordinators, Physician Assistants, technicians, etc.). As pointed out by the FDA in their 2009 Guidance for Industry: Investigator Responsibilities, “When tasks are delegated by an investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated.” Sites and sponsors often choose to utilize delegation logs as a way to document those assigned responsibilities, although the log itself is not required by the federal regulations.

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.