Clinical Researcher—November 2018 (Volume 32, Issue 9)
Nikki Couturier, BSRT (T) (CT), CCRC, ACRP-CP; Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP
Do you remember when you thought life would be like a feel-good movie where you (the protagonist) have a dream or goal in mind, there is a temporary setback, but all ends well without too much struggle? In real life, you are more likely to find that while the temporary setback is, indeed, temporary, it not only involves intense layers of complexity, but the goal seems confusing and ever-changing.
Have you had your dream career or goal take on an “Inception” feel rather than a “Breakfast Club” feel? Have you ever really had all your obstacles resolved in a day—in any setting? Just look around at where you work right now; is there any better term than layered complexity for the systems and processes involved in clinical trial conduct these days?
“Basic” Isn’t So Basic, Anymore
Lifelong learning is a core tenet of being successful in one’s career, but what we’re describing here isn’t lifelong learning. The research industry is highly complex, to the point that “basic” training becomes a cycle of intense training and re-training lasting a year or more. It becomes understandable that training new employees can be a full-time job—and in our company, it is. We have a position dedicated to clinical research coordinator (CRC) training, and we still need to bring in dozens of other people to help.
It takes at least 20 hours minimum to onboard a new hire and train them on our company culture, policies, and general knowledge about the clinical research enterprise, such as phases of studies and how clinical research impacts the world’s health and healthcare costs. For a CRC, the training is exponentially more in depth, taking an additional 240 hours for the “basics” of what they are likely to encounter in their everyday responsibilities (see Figure 1).
|Figure 1: Elements of Basic Training for CRCs
Good Clinical Practice
Investigational Product Reconciliation and Storage
Principal Investigator Responsibilities and Delegation
Informed Consent Process
Pre-Study Visits and Site Initiation Visit Processes
Patient Visit Documentation
ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) Source Data Principles
Adverse Event/Serious Adverse Event (AE/SAE) Reporting
Monitoring Visit Conduct
Software Training (Clinical Trial Management System, eRegulatory, eSource, Electronic Data Capture, Interactive Web Response System, Patient Recruitment Portals, Institutional Review Board Portals, etc.)
Off to the Races?
Imagine that after the initial training, this new CRC is “trained” and up and running on four enrolling trials. Off they go, right? Sure, in a perfect world, but this is research we are talking about, and right when you and the CRC think they can manage to keep their head above water, something changes. The CRC receives a protocol amendment or clarification letter. Patients cannot be reached and miss scheduled visits. A new sub-investigator starts and trial training and delegation need to be documented. A patient has an SAE. The CRC has an undertrained clinical research associate (CRA) visiting from the sponsor and is being given bad direction from them. (We are certain that CRA trainers have the same issues we do, but that doesn’t change the fact that misdirection from our clients’ representatives can set CRC training back significantly.)
After the initial, multi-month training, the CRC reaches deeper layers of learning week after week, almost without fail and without break. Reading about something just doesn’t cut it when it’s time to put information into action. Training and re-training are a constant at the site level for at least the first year.
Oddly, when an error occurs (even when it’s not the site’s fault), the response from many CRAs is to tell the CRC what went wrong and to document that as “re-training.” It seems to be our answer for any problem that arises—like a big Band-aid we apply when our knee gets skinned. In adult learning theory, though, most information needs to be explained at least seven times before it is fully understood. Dedicated instruction is a help, but it is the sheer volume of information a new CRC needs to learn that is the problem. With all of the general training added to the hundreds of pages of training in each protocol, what is the math on hearing those items seven times apiece to be proficient?
Keeping the Pipeline Healthy
The biggest complaint we receive from CRCs during their exit interviews is that they felt undertrained for the demands of the job. Despite literally several hundred hours of dedicated, specific training, the job of a CRC is so complex that some people feel we failed to prepare them. Those among us who appreciate deep complexity as being enthralling and invigorating learn to adore this work, but how high is the barrier to entry being set in this industry for even “beginners”? Many articles have been written about the difficulty finding and training CRAs at an ample pace, and what we are discussing is the same problem at the site level for CRCs.
To be successful, the industry needs many patients in many trials. Additional patients bring with them the need for ever-more investigators and CRCs.
Our core focus as a site is to find research participants who qualify for research studies, educate them about their roles and responsibilities as a participant, capture the highest quality data possible, provide the best possible patient care, and meet all deadlines that the sponsor requires to help in their endeavor to get their drug or device to market as fast and safely as possible. Intellectually, we are all united in this endeavor. However, actions speak louder than words, and the disjointed use of vendors and electronic systems, the lack of payment to sites from sponsors for the overhead involved in having well-trained CRCs, and the incredible complexity of trial protocols at least threaten—and often succeed at—defiance of our collective goals for seeing research thrive.
Nikki Couturier, BSRT (T) (CT), CCRC, ACRP-CP, (email@example.com) is the Contract and Budget Manager and a member of the Quality Assurance and Compliance Committee at IACT Health.
Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, (firstname.lastname@example.org) is the Chief Implementation and Operations Officer and a member of the Quality Assurance and Compliance Committee at IACT Health.