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Assessing past performances

Monday, May 11, 2015

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The adage “Keep the past in the past” does not apply to clinical research best practices.

A retrospective reflection of past experience/performance has multiple benefits. It can help correct or prevent deficits, especially through a “lessons learned” discussion following a trial’s conclusion. Whether with clinical operations or site staff, transparent discussions of deficiencies that occurred during a study prevent similar errors and assist with future resolutions.

Assessment of past performance also can serve as a teaching tool. A training process that integrates case studies not only provides the trainee an interactive learning process; it also allows the trainer to assess ability to problem solve and identify areas of strength or weakness. 

How to prepare for your first monitoring visit
(For a new Study Coordinator, or one inheriting trials without a predecessor to train her)

  • Review the correspondence section of the regulatory binder, specifically prior emails from monitors or study team members, to acquaint yourself with the current status of the trial.
  • Review IRB correspondence, protocol and ICF approval letters. The IRB approval letter clarifies the study status, any amendments and the IRB continuing review date. The ICF approval date will clarify the most recent ICF version/approval, crucial to consenting study patients.
  • Review prior monitoring letters. The monitoring visit follow-up letter is a recap of what occurred at the last visit and any pending items. It contains specific actions required for resolution.
  • Look through the binder or correspondence for contact information for your monitors. In an email or phone call, introduce yourself and your situation, ask the monitor to prioritize the most crucial tasks requiring resolution, the specific CRFs/eCRFs/patient source documents to retrieve/address for the next visit and the most critical tasks to tackle before they arrive.

I continuously assess my performance, how I train and how I interact with site staff. This allows me to objectively reflect on what was positively, or poorly, completed. My accomplishments motivate me, while my deficiencies humble and stifle overconfidence, preventing repetition of errors. Self-assessment is a continuous journey toward excellence: It is impossible to attain perfection, but in pursuit of our personal best we continuously evolve and perfect our efforts.  

Reflection of past performance can be bittersweet. When I started in clinical research as a new Study Coordinator (SC), I was in a backlogged research practice bereft of proper oversight and staff for nearly six weeks. My Principal Investigator (PI) was a successful internal medicine physician who had to prioritize patient care over clinical trials while she sought to hire the right nurse for her research practice. In me she saw enthusiasm, willingness and the opportunity to train someone new to research to successfully manage her studies. And so to the horror of the research administrator at the clinic, I had a monitoring visit scheduled during my second week on the job. My PI was a global thinker; she quickly could assess what was required to achieve the end result. She knew an experienced monitor would be the most effective indoctrination to clinical trial conduct and process.

Unfortunately, her creative thinking challenged the established institutional training plan and an old-school administrator mired in policy. Things were done a certain way, and deviations severely resisted. So instead of applauding the plan to have the monitor train me, the administrator tried to present a scenario to me of rigorous expectation beyond my limited experience. Her unfair description of the monitor’s role—finding and escalating errors—contributed to my growing apprehension of my ability to perform my new role. Instead of eagerly anticipating the opportunity to learn, I dreaded what surely would be a fault-finding session.    

How could I prepare adequately for something I knew nothing about? I did not yet understand the content or purpose of the study folders I had inherited, but I grasped that neatness was more optimal than disarray, so I grouped each chart according to study number.  

To my relief, the monitor was detailed, organized and an incredibly patient teacher. His first words, thoughtful and effective: “I know how overwhelming all of this is. I am here to help you through it.” I felt comfortable, relieved and extremely motivated. He knew what I needed to hear to transform my reluctance into enthusiasm. 

He immediately set me to work reviewing regulatory binders, protocols and clinical research fundamentals. This allowed me to assimilate information quickly, yet comprehensively. I learned the true definition of site management: a CRA and SC working together to solve problems, not a task master and subordinate. 

He explained each step of a monitoring visit, preparation, conduct and follow up, including detailed review of the prior visit follow-up letter and how to identify and start to resolve items pending from the previous visit. He explained monitoring query forms and helped me address and resolve each pending data clarification, from verifying blood pressure results on a Case Report Form (CRF) to explaining how to correct data in source documents and helping me comb through medical records to complete missing CRF data. He even gave me a note-to-file template and helped me craft my first memo-to-file to report protocol deviations. Nothing was too menial or time consuming.

Most importantly, he taught me how an inexperienced SC can best become familiarized with the role and prepare for future monitoring visits. 

When faced with a seemingly insurmountable problem, thinking beyond outdated processes can lead to creative solutions that both resolve and prevent problems. My PI provided an alternate training plan that allowed me to step into my role sooner than if she had complied with the established procedure.

Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles. Currently she works in relationship development/study startup in the CRO industry. Email ebwcra@yahoo.com

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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