Compliance In Focus

During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans.  But what about back-up coordinators- are they trained and ready?

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

Gamification is defined as “the process of turning an activity or task into a game or something resembling a game.” This concept has been leveraged in the fields of education and marketing to create engagement with a topic or product by using game playing techniques such as point scoring, achievement badges, or virtual currency.

Please take time to review Emily Haglund’s article “Risk Management in Clinical Research Process and Application” that was recently posted on GxP Lifeline.  The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

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:

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

When it comes to the Battle of the Sexes you may be surprised to hear this competition is a popular one in the field of health research. On Tuesday, September 22, 2014 the National Institutes of Health (NIH) announced that it will be distributing $10.1 million in grants to scientists and research facilities studying a host of topics, from drug addiction to migraines.  These funds are intended to help support the inclusion of more research subjects, particularly females, in studies that require a little more representation of the XX chromosomes in their laboratory subjects. This means the participation of more female animals, even cell lines, in research laboratories.  The remainder of the awarded money will be used to supplement analysis of gender differences in the studies’ resulting data.

I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be?  The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances  I observe as I conduct clinical investigator audits. Let me elaborate.

An article was recently published in the Clinical Researcher entitled “Increasing Provider Engagement in Clinical Research Starts with Research Awareness:  Leveraging Education and Technology to Improve Participation”.  In this article, the authors indicated that whether directly or indirectly involved with clinical trials, increasing research awareness may increase health outcomes, study accrual, and patient safety.  Subsequently, the ability to enroll in a clinical research trial may improve patient care for some individuals and result in better outcomes for future patients.  Without increasing accrual, sites and sponsors are not able to efficiently conduct clinical trials.

Advancements are always being sought out to improve clinical research administration, with better patient care as the ultimate goal.  According to an article on The Association of Academic Health Centers website, the current administrative landscape for clinical trials is exceedingly complex.  Many interdependent functions are spread across the research enterprise, which often results in the establishment of administrative structures and small bureaucracies operating as separate, unconnected silos that lack policies or formal procedures for communications and interaction.  The article goes on to explain that the life cycle of a clinical research project involves stakeholders from different realms of academic health center administration who possess various skills and knowledge about clinical research or business functions.

Most of us have been there before.  In an attempt to get that last item completed before the end of another long day on the job in the field of clinical research we inadvertently scribe the wrong date on the research record we are completing.  We are all human after all, and mistakes do happen from time to time.  Sometimes we know instantly and can correct ourselves, and others someone else points out the discrepancy that we may have over looked.  It’s how we respond after we are made aware that we have made the mistake that I want to focus on for this blog post because there are multiple different options one can take.

I came across an article describing the benefits to having a shortened informed consent form.  As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.

You may be familiar with IMARC Research’s History of Clinical Research (HCR).  We recently released an eBook about it that briefly describes all of the images that currently make up the timeline.  If you have visited our office, you may have also been given a guided tour of one of our most renowned resources.  Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

For a sponsor or investigator, selecting the right Contract Research Organization (CRO) to help with the monitoring and management of a clinical trial can be crucial to a successful outcome.

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

Coming from a background of working as a patient care nurse in the ICU, I would witness the consent process on a daily basis for biopsies, bronchoscopies, chest tubes, arterial lines, etc... These were non-research procedures; they were procedures to assist in the treatment of the critically ill. When I first started a career in research, I already knew that obtaining consent was more than a piece of paper and that it was a discussion and a process, but “a consent is a consent” for standard treatment in a hospital or for research, right? WRONG- I found out very quickly through IMARC’s training program that obtaining consent in research involves so many different specific elements, different from an informed consent for non-research procedures.

I recently came across this article describing the benefits to having a shortened informed consent form.  As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.

Today's blog was submitted by guest blogger, Melissa Byrn.  Melissa is affialiated with the Office of Clinical Research at a large academic research organization and will be contributing blogs to IMARC Research.

ICH GCP E6 4.8.3 states that neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial, and special care must be taken to assure it is met when dealing with populations whose very nature places them in a situation where they might be more easily coerced or influenced.

You did it!

IMARC Monitors sometimes have a challenging job; they are often on the road, trying to balance work and home life.  They juggle multiple studies from different Sponsors, have many relationships to maintain, sites to visit, and reports to write.  At IMARC we want to always provide the very best monitoring services we can.  In order to do that we must have great monitors on staff, so, what makes a great Monitor?

Today's blog was submitted by guest blogger, Melissa Byrn.  Melissa is affialiated with the Office of Clinical Research at a large academic research organization and will be contributing blogs to IMARC Research.

IMARC monitors are all over North America on a weekly basis traveling to a wide range of sites from the small community hospital to the large medical center that also serves as a teaching institution. What makes a periodic monitoring visit a Good Visit? To those in the medical field, they may determine a good visit by the notability or prestigiousness of the facility itself. To the general population in the outside world, they may say - destination. After all, who wouldn’t want to be monitoring at the site next to the sunny, beautiful beach in southern Florida versus next to the corn field out in no man’s land? If you ask an insider, a monitor, the response would sound something like- “That visit was great. The research coordinator – she (he) was a ROCK STAR!” 

In research, we are always dealing with acronyms.  Using the story below, do you know all of the acronyms represented?

There is a new development in the story of Henrietta Lacks, the woman whose cancerous cells were obtained without her consent and developed into the immortal HeLa cell line.  You may recall that Henrietta presented to John Hopkins in Baltimore Maryland in 1951 and was treated for cervical cancer.  During her treatment, her doctors obtained a sample of healthy cervical cells along with a sample of the cancerous ones for testing.  Unexpectedly, Dr. George Otto Gey was able to keep the cells alive in a culture and they have been used without Henrietta’s permission in numerous research studies ever since.  In fact, you can still obtain a sample of HeLa cells today.  Unfortunately, Henrietta was never even informed of this and it wasn’t discovered until over 20 years later when Johns Hopkins contacted her children to see if they would be willing to give blood samples in order to better understand the immortal cells.  Not only has the Lacks family had no say in how Henrietta’s cells could be used, but they themselves have struggled to receive adequate medical care because the family has never been compensated in any way for their mother’s contribution to science.

The New York Times published an article that poses an important question to researchers- Do new medical procedures, products, and drugs work better than the old practices that they commonly replace?  It is a similar question that consumers are faced with every time a new version of their favorite cell phone is released- it is new, but is it necessarily better?

One of the fundamental principles of Clinical Research is: “if it is not documented, it is not done”. The attributes of source documentation, we, as research personnel, should be looking for are ALCOA: Attributable, Legible, Contemporaneous, Original and Accurate.  (The IMARC ALCOA Checklist is a helpful tool for understanding the importance of these qualities.)

Often clinical research trials are conducted through large, academic medical centers. This is understandable as the cost of a research department infrastructure can be beyond the budget for a community hospital.  Yet for those community hospitals willing to become involved in clinical research trials, the dividends to the institution, its staff, and the community are phenomenal. A few of these benefits are reviewed.

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans.  But what about back-up coordinators - are they trained and ready?

Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.

Informed consent is arguably the most important aspect of patient protection in clinical research. The informed consent process is intended to protect the rights and welfare of subjects by educating them about their potential participation in a clinical trial. Unfortunately, informed consent remains an issue today. In fact, the FDA has sent out many warning letters regarding informed consent over the last few years.

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

A project that has long been in the mind of Sandra Maddock’s has come to life.  The challenge was how to translate key events in clinical history into a series of images that depicted both the amazing and tragic events that have impacted medical research.

You did it!

Clinical Research Monitoring is a vital part of the Clinical Trial process, and one of the most prominent skills you’ll find in an effective monitor is exceptional communication.  Whether you’re contacting a site, writing a confirmation letter, drafting a report, or talking to an investigator, your communication skills, or lack thereof, will determine how well you are perceived and will ultimately affect your effectiveness in the clinical trial process.

We’re often asked- What makes a good monitor? What’s involved in the day-to-day of being a CRA? Well, it’s no secret that a good monitor often wears and juggles many hats; from reporter, to auditor, to traveler. And like many with this New Year quickly unfolding there are some resolutions from those that live out the day-to-day of clinical research monitoring:

As part of the Patient Protection and Affordable Act, the Sunshine Act requires medical device, pharmaceutical and similar companies to report any payment or other transfer of value to the Health and Human Services (HHS). This will effect many companies that conduct clinical research and clinical trials, but the question remains- will this negatively impact physician’s willingness to participate in research?

Recently we sent out a tweet asking this simple question: What Motivates YOU in Clinical Research? We were excited to see this answered, and retweeted by those in our industry.

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

We recognize that it might not be easy to quickly grasp the concept behind the FAIR Shake™ training program, so we have posted a video on our company website that we believe will give you a better understanding of the training program.  Sandra Maddock, CEO and President of IMARC, is featured in the video and walks you through the training methodology.

We live in a fast-paced world; a world where new technology and innovation develops in rapid succession.  We are always seeking the “latest and greatest” in technology.  Intertwined in this world of technology and innovation, lies the world of clinical research.  People who are ill or disease-ridden have faith and hope that a miracle cure or life saving device is just around the corner.  But what happens when society as a whole loses faith in clinical research?  Who will volunteer for research studies when trust in the system fails?

Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.

Each sector of the research industry faces its own unique challenges. For instance, take clinical research involving drugs versus devices. While some aspects of the research process and clinical trial are the same, their differences require special attention to have a compliant and well-controlled study. Likewise, an article titled, “Combating the challenges of medical device development,” investigates how medical device development is similar to other product development- but still faces unique challenges.

With all due respect to this iconic Hawaii5-0 quote, an interesting thing happened recently at work, IMARC’s CEO Sandra Maddock was taken away in handcuffs!  Check out IMARC's Facebook page for pictures of our jail-bird being “arrested”.  Not such an unusual story in todays post-ENRON world, but this “arrest warrant” involved raising “bail money” for the Muscular Dystrophy Association’s “2012 West Cleveland Executive MDA Lock-Up™”.   The Muscular Dystrophy Association (MDA), nationally headquartered in Tucson, AZ is the largest non-governmental sponsor of research investigating the causes of and effective treatment for neuromuscular diseases.

A new report was published by the Institute of Medicine (IOM), which outlines ten recommendations to achieve a better health care system. The report, “Best Care at Lower Cost- The Path to Continuously Learning Health Care in America,” touched on elements that directly influence our industry. The ten recommendations fell into three main categories:

As those of us who work in clinical research know, there’s always another study that needs volunteers and never enough volunteers for that study.  If you’re wanting to volunteer for a study, you can always check out ClinicalTrials.gov for information about current studies worldwide.  This site is a registry and results database for federally and privately supported clinical trials.  This site, developed by the National Institutes of Health, was designed to provide valid and correct information about clinical studies.

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:

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?

Whether on the site or sponsor level, in clinical research we are asked to use Good Documentation Practices (GDP) during the conduct of a clinical trial.  One might assume that a quick visit to the FDA website would produce the list of practices.  However, there is no Code of Federal Regulations for GDP.

As questioned in this issue of the Journal of Clinical Research Best Practices - why does the clinical research industry have such a high turnover rate for clinical research personnel?

I came across a recently published article, “Clinical Trials Have Gone Global: Is This a Good Thing?” published by Lang and Siribaddana. The title immediately caught my attention and begs the question: why is there a trend of clinical trials going over seas, and what are the possible consequences? The paper is divided sub-headings that pose the following enquiries:

This blog was written by a newer monitor with IMARC Research.  This is her experience, and certainly not representative of all research coordinators and monitors.  We thank her for sharing this, and hope others who have made the similar transition will chime in with their experiences!

Everyone has a “To-Do” List or lists; Things to do at work, at home, during the week, on the weekends, sometimes even on vacations.  To-do lists pile up and add up.  Just when you think that your list may be shortening, more to-do’s get added on or new lists are started.

For a sponsor or investigator, selecting the right Clinical Research Organization (CRO) to help with the monitoring and management of a clinical trial can be crucial to a successful outcome.

I recently came across this article describing the benefits to having a shortened informed consent form. As a monitor who has had experience with reviewing informed consents, as well as a former research coordinator who has obtained consent from study participants, I have mixed feelings on the topic.

Please take time to download IMARC's most recent white paper, written by Brandy Smith, Chief Clinical Officer for IMARC.  In summary, regulations that govern clinical research were put in place to protect clinical research subjects, and during FDA inspection, the extent to which a clinical researcher complied with those regulations – or protected patients – will come under scrutiny. If in doubt about the appropriate documentation practices, read though the regulations in question and think to yourself, how can I document my compliance with the regulation?    Oftentimes we make decisions in order to meet the regulations, but neglect to take that extra step to document our actions. If someone was to review your work, would it be clear that the regulations were followed?  The patients protected?  Please take time to review and let us know what you think.

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.

1. I will not complain when my travel plans are disrupted.
   Too loudly.
   To strangers.
   Except I will start complaining loudly to you, sir to my left, who is under the impression that he has purchased my seat as well as his own.
2. I will not get frustrated when I don't get an immediate reply to an e-mail.
   I realize that the study I have e-mailed for information about is only one of a dozen studies that the Research Coordinator is responsible for, in addition to her clinic hours, in her part-time position with the site. I realize that the in-house contact is fielding questions from fourteen sites and the Project Manager and Regulatory Affairs and Clinical Safety, and even still she usually manages to respond to me within the hour. I realize that the world does not revolve around the fact that I leave for the airport in fifteen minutes.
3. I will show my appreciation for the contributions made by the Research Coordinator.
   He has a million other things to do, and yet he clears off his desk so that I can have a comfortable place to work. He offers me coffee and shows me where the bathroom is and runs all the photocopies I request. He shows incredible grace and understanding when I enter query after query in his hard work. And after I deconstruct his hard work, he welcomes me back in two months for another visit. The least I can do is send an e-mail after our visit to thank him for his efforts.
4. I will be more productive during my travel time – but I will think twice before writing a report on the redeye back from the West Coast.
   I know from experience and way too much time spent on edits that sometimes it’s just not worth it. 
5. I will ask study staff at each site, How can I help make this better?
   Because no matter how overwhelmed a site is, because no matter how experienced and organized a coordinator is – there is something I can do to help make things run just a little more smoothly, and I’m genuinely happy to help in any way I can.

Here's to science and success in the New Year!

The process of obtaining approval for new medical devices can be a long and windy road.  This complicated and sometimes confusing process may soon get a little easier, according to an Industry News press release.